Archive for January, 2017
$NAKD and #BendonLimited Announce #LOI to #Merge
Transformative Merger Expected to Create a Powerful Portfolio of Innerwear, Sleepwear & Swimwear Brands
Naked Brand Group Inc. (NASDAQ:NAKD) (“Naked” or the “Company”), an innovative innerwear fashion and lifestyle brand, and Bendon Limited (“Bendon”), a global leader in intimate apparel and swimwear renowned for best in category technology and design throughout its 70 year history, announced today that they have entered into a Letter of Intent (the “LOI”) for a proposed merger of the companies (the “Merger”). Expected benefits of this proposed merger include:
- Bendon would gain immediate access to the U.S. capital markets enabling it to further grow the business globally, both organically and through future strategic acquisitions;
- The Naked brand would be able to leverage Bendon’s well-established global wholesale and retail distribution channels;
- The combined entity would capitalize on the industry-leading expertise of Carole Hochman, Naked’s Chief Executive Officer, to strengthen its global intimate apparel and sleepwear brand portfolio; and
- Operating synergies through integrated supply chain management and administrative functions.
Bendon’s brands include Heidi Klum Intimates and Swimwear, Stella McCartney Lingerie and Swimwear, Bendon, Bendon Man, Davenport, Evollove, Fayreform, Hickory, Lovable (in Australia and New Zealand) and Pleasure State. Bendon’s brands are distributed globally through over 4,000 doors across 34 countries, as well as through a growing network of 60 company-owned Bendon retail and outlet stores in Australia, New Zealand and Ireland. Bendon is headquartered in Auckland, and maintains additional offices in Sydney, New York, London and Hong Kong. For the fiscal year ended 2016, Bendon generated approximately NZ $144 million (US $100 million) in net sales.
Ms. Hochman stated, “We are extremely excited about the potential of this proposed merger, and look forward to capitalizing on Bendon’s scale and expertise to further expand the Naked brands. The Bendon team has built a phenomenal business, and by leveraging their infrastructure, product and geographic knowledge, and talent, we believe that we can accelerate our growth in the innerwear fashion and lifestyle market.”
Justin Davis-Rice, Executive Chairman of Bendon, commented, “This is a transformative merger that will create a powerful creative, marketing, operational and capital markets platform. As a publicly traded company in the U.S., we expect to have an opportunity to accelerate our growth and strengthen our position as a global leader in intimate apparel, swimwear, innerwear fashion and lifestyle brands through both organic growth and strategic acquisitions. We are also delighted to partner with industry pioneer, Carole Hochman, who brings unrivalled experience to our company and whose expertise is expected to not only strengthen our existing brands but to provide us with an unprecedented opportunity to develop our sleepwear business, a product category that represents a significant growth opportunity.”
Eric Watson, Executive Chairman of Cullen Investments, Bendon’s majority shareholder, added, “This is an incredible opportunity for Bendon to strengthen its leadership in the industry and drive the continued growth of the business as a consolidator of globally recognized brands.”
Carole Hochman, who will become Chief Creative Officer of the merged company, is considered one of the single most influential women in the intimate apparel and sleepwear business in the United States with experience that extends more than 30 years. She was the driving force behind the Carole Hochman Design Group, for which she served as Chief Creative Officer until her departure in 2013 and for which she was previously CEO until its acquisition by Komar in 2010. Under Carole’s leadership, Carole Hochman Design Group manufactured the Carole Hochman brand of sleepwear, loungewear and daywear, in addition to numerous other sleepwear collections including Christian Dior, Oscar de la Renta, Ralph Lauren, Jockey, Donna Karan, Tommy Bahama and Betsey Johnson.
As stated in the LOI, Mr. Davis-Rice will join Naked’s board of directors, effective immediately. Concurrent with the completion of the proposed Merger, Ms. Hochman would retain a seat on the board of the combined company.
Terms of Letter of Intent
The LOI with Bendon provides that the Company would issue the holders of ordinary shares of Bendon an aggregate of 118,812,163 shares of common stock of the Company, subject to adjustment, representing approximately 93.6% of the combined company. Completion of the Merger is subject to the negotiation of a definitive merger agreement (the “Merger Agreement”), satisfaction of the conditions negotiated therein and approval of the Merger by the Company’s stockholders. Accordingly, there can be no assurance that a Merger Agreement will be entered into or that the proposed Merger will be consummated. Further, readers are cautioned that those portions of the LOI that describe the proposed Merger, including the consideration to be issued therein, are non-binding.
Pursuant to the terms of the LOI, the Company’s management as well as certain insiders will agree to sign voting agreements pursuant to which each such person will grant a proxy and/or agree to vote for the Merger at any meeting of stockholders. In addition, key employees of Bendon will be offered employment with the Company, to be effective upon completion of the Merger. Upon completion of the Merger, the Board of the Company would be comprised of Ms. Hochman, Mr. Davis-Rice and several additional members to be identified and nominated by Bendon.
Pursuant to the terms of the LOI, the Company has agreed to adhere to a no-shop provision until the earlier of the date the Merger Agreement is executed or the LOI is terminated. If the Merger Agreement is not executed by February 10, 2017, or the Merger is not consummated within six months thereafter (each a “Merger Milestone”), the Company will be required to issue to Bendon 2.5 million shares of common stock; provided, however, that the Company shall not be required to issue Bendon such shares if Bendon’s action(s) or lack thereof has been the principal cause of or resulted in the failure of the parties to achieve a Merger Milestone.
Assuming Naked and Bendon enter into the Merger Agreement, the parties will look to seek shareholder approval from Naked’s shareholders in the first quarter of 2017, subject to SEC review of the proxy statement to be filed by the parties for the proposed transaction.
About Naked:
Naked was founded on one basic desire – to create a new standard for how products worn close to the skin fit, feel, and function. Naked’s women’s and men’s collections are available at www.wearnaked.com, and Naked has a growing retail footprint for its innovative and luxurious innerwear products in some of the leading online and department stores in North America including Nordstrom, Bloomingdale’s, Dillard’s, Soma, Saks Fifth Avenue, Amazon.com, BareNecessities.com, and more. In 2014, renowned designer and sleepwear pioneer Carole Hochman joined Naked as Chief Executive Officer, Chief Creative Officer, and Chairwoman with the goal of growing Naked into a global lifestyle brand. In June 2015, Naked announced a strategic partnership with NBA Miami HEAT (now Chicago Bulls) star Dwyane Wade. The 3-time NBA Champion, 11-time All Star, and Olympic Gold Medalist joined the Company’s Advisory Board, and is the Creative Director for a signature collection of men’s innerwear launching 2016. Naked is now headquartered in New York City and plans to expand in the future into other apparel and product categories that can exemplify the mission of the brand, such as activewear, swimwear, sportswear and more. http://www.nakedbrands.com/
About Bendon:
Bendon is a global leader in intimate apparel and swimwear renowned for its best in category innovation in design, and technology and unwavering commitment to premium quality products throughout its 70-year history. Bendon has a portfolio of 10 highly productive brands, including owned brands Bendon, Bendon Man, Davenport, Evollove, Fayreform, Hickory, Lovable (in Australia and New Zealand) and Pleasure State, as well as licensed brands Heidi Klum Intimates and Swimwear and Stella McCartney Lingerie and Swimwear.
In October 2014 Bendon announced supermodel and television host Heidi Klum as the Creative Director and face of Bendon’s flagship Intimates collection, succeeding Elle Macpherson after 25 years with the brand. Bendon products are distributed through over 4,000 doors across 34 countries as well as through a growing network of 60 company-owned Bendon retail and outlet stores in Australia, New Zealand and Ireland. Bendon’s global supply chain is one of its strongest assets, controlling sourcing, manufacturing and production at over 30 partner facilities across Asia. The company has more than 700 staff at offices and stores in Auckland, Sydney, New York, London and Hong Kong and is poised for continued meaningful growth as it opens additional retail stores and expands its current portfolio of products. http://www.bendongroup.com/
Additional Information about the Proposed Merger and Where to Find It
In connection with the proposed Merger, Naked intends to file relevant materials with the Securities and Exchange Commission, or the SEC, including a proxy statement. Investors and security holders of Naked are urged to read these materials when they become available because they will contain important information about Naked, Bendon and the proposed Merger. The proxy statement and other relevant materials (when they become available), and any other documents filed by Naked with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and securityholders may obtain free copies of the documents filed with the SEC by Naked by directing a written request to: Naked Brand Group Inc., 95 Madison Avenue, 10th Floor, New York, New York 10016, Attention: Investor Relations. Investors and securityholders are urged to read the proxy statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed Merger.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities
Participants in the Solicitation
Naked and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Naked in connection with the proposed Merger. Information regarding the special interests of these directors and executive officers in the proposed Merger will be included in the proxy statement referred to above. Additional information regarding the directors and executive officers of Naked is also included in Naked’s Annual Report on Form 10-K for the year ended January 31, 2016 and the proxy statement for Naked’s 2016 Annual Meeting of Stockholders. These documents are available free of charge at the SEC’s web site (www.sec.gov) and from Investor Relations at Naked at the address described above.
Forward-Looking Statements Safe Harbor
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve a number of risks and uncertainties related to operating performance and outlook of Naked and the combined businesses of Naked and Bendon following the Merger, as well as other future events and their potential effects on Naked and the combined company that are subject to risks and uncertainties. The following factors, among others, in the future could cause Naked’s or Bendon’s actual results, performance, achievements or industry results to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. These factors include, but are not limited to, statements relating to the possibility that Naked and Bendon are able to execute the Merger Agreement when expected or at all; the structure, timing and completion of the proposed Merger; Naked’s continued listing on the NASDAQ Capital Market until closing of the proposed Merger; the combined company’s listing on the NASDAQ Capital Market after closing of the proposed Merger; the benefits of the Merger, including future financial and operating results of the combined company, Naked and Bendon’s plans, objectives, expectations and intentions, and the ability to realize the expected synergies or savings from the proposed Merger in the amounts or in the timeframe anticipated; the risk that competing offers or acquisition proposals will be made; the ability to integrate Naked’s and Bendon’s businesses in a timely and cost-efficient manner; the inherent uncertainty associated with financial projections; the potential impact of the announcement or closing of the proposed Merger on customer, supplier, employee and other relationships. In addition, these forward-looking statements necessarily depend upon assumptions, estimates and dates that may be incorrect or imprecise and involve known and unknown risks, uncertainties and other factors. Accordingly, any forward-looking statements included in this announcement do not purport to be predictions of future events or circumstances and may not be realized. Forward-looking statements can be identified by, among other things, the use of forward- looking terms such as “believes,” “expects,” “may,” “will,” “should,” “seeks,” “anticipates,” “intends,” “continues,” “could,” “estimates,” “plans,” “potential,” “predicts,” “goal,” “objective,” or the negative of any of these terms, or comparable terminology, or by discussions of our outlook, plans, goals, strategy or intentions. Forward-looking statements speak only as of the date made. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we assume no obligation to update any of these forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting these forward-looking statements.
Investors:
ICR
Jean Fontana/Megan Crudele, 203-682-8200
jean.fontana@icrinc.com
or
Media:
ICR
Alecia Pulman/Brittany Fraser, 203-682-8200
NakedBrandsPR@icrinc.com
$GLBS Announces Update Regarding #PrivatePlacement
ATHENS, GREECE– (Jan 13, 2017) – Globus Maritime Limited (“Globus,” or the “Company”), (NASDAQ: GLBS), a dry bulk shipping company, announced today that its previously disclosed private placement and conversion of debt will not occur as planned. The transaction was previously described in the Company’s press release issued on November 28, 2016 and Current Report on Form 6-K filed with the Securities and Exchange Commission on November 29, 2016. These transactions with multiple parties had to all close simultaneously, but one party has not agreed to consummate the transaction.
This news release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The securities offered have not been registered under the U.S. Securities Act of 1933, as amended, or any other securities laws and may not be offered or sold in the United States or to a U.S. person absent registration or an applicable exemption from registration requirements.
About Globus Maritime Limited
Globus is an integrated dry bulk shipping company that provides marine transportation services worldwide and presently owns, operates and manages a fleet of dry bulk vessels that transport iron ore, coal, grain, steel products, cement, alumina and other dry bulk cargoes internationally. Globus’ subsidiaries own and operate five vessels with a total carrying capacity of 300,571 DWT and a weighted average age of 8.8 years as of December 31, 2016.
Safe Harbor Statement
This communication contains “forward-looking statements” (as defined in Section 21E of the Securities Exchange Act of 1934, as amended). Forward-looking statements provide the Company’s current expectations or forecasts of future events. Forward-looking statements include statements about the Company’s expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts or that are not present facts or conditions. Words or phrases such as “anticipate,” “believe,” “continue,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “will” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The Company’s actual results could differ materially from those anticipated in forward-looking statements for many reasons specifically as described in the Company’s filings with the Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements, which speak only as of the date of this communication. Globus undertakes no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this communication or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks Globus describes in the reports it will file from time to time with the Securities and Exchange Commission after the date of this communication.
For further information please contact:
Globus Maritime Limited
Athanasios Feidakis
CEO, CFO
+30 210 960 8300
a.g.feidakis@globusmaritime.gr
Capital Link – New York
Nicolas Bornozis
+1 212 661 7566
globus@capitallink.com
$BVXV #Universal #Flu #Vaccine Candidate Efficacy Highlighted In Recent Study
NESS ZIONA, Israel, January 12, 2017 —
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), developer of the Universal Flu Vaccine candidate M-001, reports the publication this week of an article titled, “Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune responses against 2014/15 epidemic strain” in the prestigious peer-reviewed scientific journal Vaccine.
The Vaccine article reports that blood plasma samples from people who received M-001 in 2011 (as part of BiondVax’s BVX-005 clinical trial in the elderly) showed significantly increased protective antibodies against the new epidemic 2014/15 flu strain (A/Swiss) – a strain which did not exist when M-001 was administered to the BVX-005 participants.
Despite the $4.3 billion market[1], current flu vaccines have many shortcomings including that they are specific to just 3 or 4 existing flu strains, and must be reformulated each year. Furthermore, seasonal flu vaccine effectiveness is only about 40% on average[2], and as low as 9% in the elderly[3] who are the most at risk group. Conversely, as a universal flu vaccine candidate, M-001 is designed to provide improved and broad protection against all current and future seasonal and pandemic flu strains.
The study reported in Vaccine offers evidence of the broadening protective effects offered by M-001, a significant advantage over current flu vaccines.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientist and co-inventor of M-001, commented, “We consider this study to provide validation of M-001’s potential. It is a promising indication that our vaccine may provide improved protection against future flu strains, including potentially pandemic strains that don’t yet exist!”
The article also discusses M-001’s mechanism of action. It is available online at http://www.sciencedirect.com/science/article/pii/S0264410X1631297X.
About BiondVax Pharmaceuticals Ltd
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, general business conditions in the industry, changes in regulatory and legal compliance environments in which BiondVax engages, the adequacy of available cash resources to fund product development and commercialization and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
1. EvaluatePharma: Quoted by Edison Research http://www.edisoninvestmentresearch.com/research/report/biondvax-pharmaceuticals/preview/ [accessed 12 January 2017].
2. CDC: Seasonal influenza vaccine effectiveness, 2005-2016. https://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm [accessed 11 January 2017].
3. CDC: Interim adjusted estimates of seasonal influenza vaccine effectiveness – United States, February 2013. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6207a2.htm [accessed 11 January 2017].
BiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit http://www.biondvax.com.
For further information, please contact:
Joshua E Phillipson
Business Development
+972-8-930-2529 x5105
j.phillipson@biondvax.com
Kenny Green
Investor Relations
+1-646-201-9246
kenny@biondvax.com
$STRP #Settles With the #FCC
Straight Path Remains the Largest Holder of 39 GHz Spectrum and Significant Holder of 28 GHz, Continuing Its Leadership in Developing 5G Wireless Technology
Straight Path Communications Inc. (NYSE MKT:STRP), one of the largest holders of flexible mobile and fixed-use wireless millimeter wave spectrum, today announced a comprehensive settlement with the Federal Communications Commission (FCC) related to the company’s wireless spectrum licenses. As part of the agreement, the FCC has terminated its investigation of Straight Path, and Straight Path can now move forward with the vast majority of its nationwide 39 GHz spectrum fully intact, and its 28 GHz spectrum unchanged. Both of these spectrum bands, 28 and 39 GHz, were the recent beneficiaries of a dramatic rule change instituted in July 2016 by the FCC’s Spectrum Frontiers Report & Order. The change allows these bands to be used for mobile wireless and is central to the industry-wide push to 5G, in order to provide higher speeds to hundreds of millions of consumers and businesses throughout the U.S.
Straight Path Communications CEO Davidi Jonas commented on the FCC settlement:
“We are pleased that we were able to achieve a comprehensive settlement with the FCC, which allows us to move forward as the largest holder of 39 GHz spectrum, with about 95 percent of the total licenses commercially available at this time, as well as a significant holder of 28 GHz in major markets, including New York and San Francisco. These licenses allow us to continue as a leader in the next frontier of telecommunications.
“Straight Path Communications’ spectrum is part of the bedrock for 5G and will play an important role in the development of this next-generation ecosystem, underscored by activities already underway by leading wireless carriers and equipment manufacturers in the U.S.
“Post-settlement, Straight Path Communications holds an average of 620 MHz in the top 30 U.S. markets and covers the entire nation with 39 GHz spectrum. Additionally, the Company has retained all of its 28 GHz spectrum licenses.
“With this settlement, we have cleared the way for a review of strategic alternatives to maximize shareholder value. To represent us in our endeavors, we have retained Evercore, a premier independent investment banking advisory firm.
“We look forward to continuing our role in the important development and deployment of 5G technology. This includes accelerating the innovative hardware and software we are developing for Fixed 5G® in our Gigabit Mobility Lab in Plano, Texas, under the guidance of our CTO, Jerry Pi, a renowned pioneer in millimeter wave 5G.”
At 8AM ET TODAY (Thursday, January 12) Straight Path Communications will host a media call to discuss this announcement. For dial-in information please email: pmb@skdknick.com
Settlement terms
Straight Path will move forward with a full national network of 735 licenses, including deep coverage in major markets, totaling more than 175 billion MHz-PoPs in 39 GHz spectrum, while agreeing to return 93 of its 828 39 GHz spectrum licenses to the FCC. Straight Path will also move forward with all of its 28 GHz spectrum, totaling approximately 39 billion MHz-PoPs, covering many key markets. Straight Path agreed to pay $15 million in installments over a nine-month period. The company also agreed to proceed with its plan to market its spectrum assets to maximize shareholder value. Straight Path agreed to pay the FCC 20 percent of the value received from a sale of its spectrum assets. If Straight Path does not announce a transaction within 12 months, it will pay another $85 million to the FCC (or return its spectrum licenses to the FCC).
About 5G and Frequency Bands 28 GHz and 39 GHz
5G is the next chapter of wireless innovation. As outgoing FCC Chairman Tom Wheeler stated: “If the United States is going to continue to be a world leader in wireless, we need to speed the deployment of 5G, here, on our shores.”
Unlike 4G, 5G technology relies on uncongested spectrum bands such as 28 GHz and 39 GHz that are free of interference. Compared to today’s 4G networks, 5G could allow wireless carriers to deliver data to users at speeds 10 times as fast, and with only 1 millisecond of delay. Straight Path Communications has been a leader in championing the use of these bands to unlock the potential of 5G technology. The company is a contributing member of ATIS 3GPP, the leading standard-setting body for 5G, and worked closely with the FCC to help adopt “Spectrum Frontiers” rules that open up new spectrum bands, including 28 GHz and 39 GHz, for flexible mobile and fixed-use wireless broadband.
About Straight Path Communications Inc.
Straight Path (NYSE MKT: STRP) holds an extensive portfolio of 39 GHz and 28 GHz wireless spectrum licenses. Straight Path is developing next generation wireless technology through its Straight Path Ventures subsidiary. Straight Path holds licenses and conducts other business related to certain patents through its Straight Path IP Group subsidiary. Additional information is available on Straight Path’s websites.
Corporate: www.straightpath.com
Spectrum: www.straightpath39.com
Safe Harbor
In this press release, all statements that are not purely about historical facts, including, but not limited to, those in which we use the words “believe,” “anticipate,” “expect,” “plan,” “intend,” “estimate, “target” and similar expressions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. While these forward-looking statements represent our current judgment of what may happen in the future, actual results may differ materially from the results expressed or implied by these statements due to numerous important factors, including, but not limited to, those described in our Annual Report on Form 10-K for the fiscal year ended July 31, 2016 and our other periodic filings with the SEC (under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”). We are under no obligation, and expressly disclaim any obligation, to update the forward-looking statements in this press release, whether as a result of new information, future events or otherwise.
Straight Path Communications Inc.
Yonatan Cantor, 804-433-1523
yonatan.cantor@straightpath.com
$APOP Receives #Patent Notice of Allowance from #USPTO
Method of treatment patent provides important protection in type I diabetes, inflammatory bowel disease, graft versus host disease and transplant rejection
TEL AVIV, Israel, Jan. 12, 2017 — Cellect Biotechnology Ltd. (Nasdaq:APOP) (TASE:APOP), a developer of stem cells isolation technology, announces today that it has received a formal notice of allowance around a key method of treatment patent (Application No. 13/811,374) from the United States Patent & Trademark Office. The allowed claims relate to the engineering of regulatory immune cells with enhanced apoptotic activity to be used for immunomodulation for treating or preventing immune related disorders.
The patent that we expect to be granted based on the allowed claims will protect Cellect’s technology and method when used for treating multiple medical conditions with significant unmet needs, such as type I diabetes, inflammatory bowel disease, graft versus host disease, and transplant rejection.
Shai Yarkoni, CEO, commented that: “This is a key milestone for us and an important initial accomplishment for our business in the US. Cellect has seven families of patents and patent applications to protect its core assets for enabling stem cell regenerative medicine.”
About Cellect Biotechnology Ltd.
Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ:APOP), (NASDAQ:APOPW), (TASE:APOP). The Company has developed a breakthrough technology for the isolation of stem cells from any given tissue, a technology that aims to improve a variety of stem cells applications.
The Company’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells for in quantity and quality that will allow stems cell related treatments and procedures. Cellect’s technology is applicable to a wide variety of stem cells related treatments in regenerative medicine and that current clinical trials are aimed at the cancer treatment of bone marrow transplantations.
Forward Looking Statements
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss our expectation that a patent will be issued based on the allowed patent, the potential of our technology and its proposed uses. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.’s final prospectus dated July 29, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. and in the Company’s period filings with the SEC and the Tel-Aviv Stock Exchange.
Contact Cellect Biotechnology Ltd. Eyal Leibovitz, Chief Financial Officer www.cellectbio.com + 972-9-974-1444 LifeSci Advisors Bob Yedid, Managing Director 646-597-6989 bob@lifesciadvisors.com
$TBIO Announces: #LifeLabs Selects #ICE #COLDPCR
Three-Year Renewable Agreement Also Includes Non-Exclusive License to ICP in Canada
New Patent Has Issued Covering ICE COLD-PCR Technology in Canada
Transgenomic, Inc. (TBIO) (NASDAQ: TBIO), today announced a licensing agreement with leading Canadian laboratory services provider LifeLabs, which has selected Transgenomic’s ICE COLD-PCR (ICP) technology as its mutation enrichment platform for cancer testing. The three-year, renewable agreement includes a non-exclusive license to the ICP technology in Canada. Separately, Transgenomic also announced issuance of a new Canadian patent for ICP.
“LifeLabs is among the largest laboratory service providers in North America, and we view their adoption of ICE COLD-PCR as a key validation of both the technology and our commercial model that focuses on licensing to a wide variety of molecular diagnostics partners worldwide,” commented Paul Kinnon, President and Chief Executive Officer of Transgenomic. “We believe that this sizable commercial licensing agreement is indicative of the growing traction in the marketplace we have been anticipating, and we believe that it will be followed by additional significant ICP agreements going forward.”
LifeLabs intends to use ICE COLD-PCR with tissue samples and is receiving a non-exclusive license to the ICP technology in Canada. The three-year renewable agreement also allows LifeLabs to benefit from technology improvements and additional product launches during its term.
“As the largest laboratory service provider in Canada, LifeLabs is committed to offering our customers access to advanced clinical genomic analyses made possible by major new technologies such as ICE COLD-PCR,” said Joby McKenzie, Senior Vice President, Business Development of LifeLabs. “We anticipate that this flexible, versatile mutation enrichment technology will be applied to other molecular testing applications as adoption of genomic and precision medicine expands.”
Recently-issued Canadian Patent No. 2792433, Full Cold-PCR Enrichment with Reference Blocking Sequence, covers the use of the ICE COLD-PCR method that enriches mutated DNA sequences in a background of normal DNA through to 2030. This method can be applied to the analysis of very low quantities of circulating tumor DNA found in a patient’s blood.
Transgenomic’s ICE COLD-PCR technology delivers up to a 500-fold increase in mutation detection compared to most current methods, with levels of detection routinely achievable down to 0.01%. This ultra-high sensitivity enables detection of low level mutations that allow accurate patient monitoring as well as stratification of cancer sub-populations. ICP works well with most patient samples, including tissue, blood, plasma, urine and other biofluids and it is compatible with most of the downstream genomic analytic platforms commonly available in laboratories today.
ICE COLD-PCR was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed worldwide rights to the technology to Transgenomic.
About LifeLabs
LifeLabs is a Canadian-owned company with over 50 years of experience providing laboratory testing services to help health care providers diagnose, treat, monitor and prevent disease in patients. In communities across British Columbia and Ontario, LifeLabs delivers cost-effective, convenient access to laboratory testing services essential for optimal outcomes in health care. LifeLabs employs over 5,000 professionally trained staff and delivers over 100 million laboratory tests, supporting over 19 million patient visits annually. In 2013, LifeLabs acquired BC Biomedical in British Columbia and CML HealthCare in Ontario, making LifeLabs the largest community laboratory in Canada. LifeLabs is indirectly owned by OMERS Administration Corporation, whose interest is managed by Borealis Infrastructure.
About Transgenomic
Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in oncology and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE COLD-PCR, which enables use of liquid biopsies for mutation detection. The company also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management’s current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets, expectations regarding new clients, projects and prospects, and MX-ICP’s ability to accelerate the Company’s growth and generate revenue. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic’s filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
Media:
BLL Partners
Barbara Lindheim, 212-584-2276
blindheim@bllbiopartners.com
or
Investors:
Transgenomic Investor Relations
investor.relations@transgenomic.com
$NETE #PayOnline New Client a Top #Russia C2C Accommodation Rental Service
Sutochno.ru receives over 700,000 online booking requests annually
MIAMI, FL–(Jan 12, 2017) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a provider of global mobile payment technology solutions and value-added transactional services, today announces that Sutochno.ru, the leading C2C short-term accommodation booking service in Russia, is now a client of PayOnline.
Sutochno.ru features over 70,000 property listings, which last year attracted more than 700,000 guests who used the platform to book short-term accommodations throughout Russia. Sutochno.ru differentiates itself from Airbnb by being more country specific and offering a more attractive pricing model for guests. Additionally, while Airbnb takes commissions from the guests, Sutochno.ru only charges the hosts a commission and an optional fee to have a priority position in the list of available properties.
“We are excited to partner with PayOnline for our payment processing needs. PayOnline provides us with a complete solution for all of our payment needs such as pre-authorization, escrowing and payment processing via all types of cards,” commented Yuri Kuznetsov, founder of Sutochno.ru. “Together with PayOnline we are developing innovative mechanisms specific to our business that will add convenience, security and enhance the user experience.”
“We are honored to see Sutochno.ru amongst our merchants; PayOnline has invested heavily in product development, and it is rewarding to see how merchants can utilize the capabilities of our platform to meet their business needs and provide an excellent experience to the end consumer,” commented Marat Abasaliev, CEO of PayOnline.
About Sutochno.ru
Sutochno.ru is a Russian based peer-to-peer marketplace allowing consumers to list their residential properties for other consumers to book on a short-term basis. The company was launched 5 years ago, currently serves over 700,000 guests on an annual basis and has over 70,000 active listings. Further information is available at www.sutochno.ru.
About Net Element
Net Element, Inc. (NASDAQ: NETE ) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US it aims to grow transactional revenue by innovating SME productivity services such as its cloud based, restaurant point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Further information is available at www.netelement.com.
Forward-Looking Statements
Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to whether the relationship with Sutochno.ru will positively impact the Company. Additional examples of such risks and uncertainties are : (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
Net Element
+1 (786) 923-0502
media@netelement.com
$HTM Announces Substantial Increase in the #SanEmidioII #Reservoir Capacity
BOISE, IDAHO–(Marketwired – Jan. 11, 2017) – U.S. Geothermal Inc. (the “Company”) (NYSE MKT:HTM), a leading and profitable renewable energy company focused on the development, production, and sale of electricity from geothermal energy, announced today that the estimate of the geothermal reservoir capacity associated with its San Emidio II project has increased from the earlier estimate of 10 net megawatts, to an estimated generation capacity of up to 47 net megawatts. This increased capacity is in addition to the current 10 megawatts being produced by the existing San Emidio I plant.
In early 2016, five 1,000 foot temperature gradient wells were drilled in the Southwest Zone and later in the year, two of those wells were deepened. Both wells intersected a high permeability, high temperature geothermal reservoir. Data from flow tests that took place in late 2016 on the two deepened wells were incorporated into a Probabilistic Power Density model developed by Geothermal Science Inc., an independent geothermal reservoir engineering company. Based on the flow rate and temperature produced by the two wells, and by measurement of pressure response across the wellfield, the model estimates that the area encompassed by the five wells drilled in 2016 (.18 square miles) has a 90% probability of 18.8 net megawatts of generation capacity as the Minimum. A larger area (1.4 square miles), defined by additional temperature gradient wells and geophysics, has a 50% probability of 47 net megawatts of generation capacity and was rated as the Most Likely outcome.
“This large increase in the size of the San Emidio II reservoir is an exceptional result from our development program,” said Dennis Gilles, Chief Executive Officer. “Having the ability to add a larger power plant to our San Emidio complex will help reduce capital and operating costs, and give us a very cost competitive project. Additionally, it will allow us to deploy two, or possibly three, of the previously acquired power plants whose acquisition we had announced in early 2016.”
The three remaining 1,000-foot-deep temperature gradient wells all have high temperature gradients and bottomhole temperatures indicating that an active geothermal resource exists below them. Permits to deepen these three remaining wells down into the production reservoir were received from the Bureau of Land Management and State of Nevada in late December. Subject to weather conditions, drilling to deepen those wells is planned for the first quarter of 2017. If the three wells intersect geothermal resource with similar permeability and temperature, the extent of the resource may be expanded and its power generation estimate increased. Additional permitting that will allow for more drilling to further expand the resource and to prepare for site development and construction activities is also underway.
About U.S. Geothermal Inc.:
U.S. Geothermal Inc. is a leading and profitable renewable energy company focused on the development, production and sale of electricity from geothermal energy. The company is currently operating geothermal power projects at Neal Hot Springs, Oregon, San Emidio, Nevada and Raft River, Idaho for a total power generation of approximately 45 MWs. The company is also developing an additional 90 MWs of projects at: the Geysers, California; a second phase project at San Emidio, Nevada; at Crescent Valley, Nevada; and the El Ceibillo project located near Guatemala City, Guatemala. U.S. Geothermal’s growth strategy is to reach 200 MWs of generation by 2021 through a combination of internal development and strategic acquisitions.
For more information, please visit our website at: http://www.usgeothermal.com
The information provided in this news release may contain forward-looking statements within the definition of the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995. Readers are cautioned to review the risk factors identified by the company in its filings with US and Canadian securities agencies. All statements, other than statements of historical fact, included herein, without limitation, statements relating to the future operating or financial performance, development schedules or estimated resources of U.S. Geothermal, are forward-looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. These forward-looking statements may include statements regarding perceived merit of properties; interpretation of the results of well tests; project development; resource megawatt capacity; capital expenditures; timelines; strategic plans; or other statements that are not statements of fact. Forward-looking statements involve various risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from U.S. Geothermal’s expectations include the uncertainties involving the availability of financing in the debt and capital markets; uncertainties involved in the interpretation of results of well tests; the need for cooperation of government agencies in the development and operation of properties; the need to obtain permits and governmental approvals; risks of construction; unexpected cost increases, which could include significant increases in estimated capital and operating costs; and other risks and uncertainties disclosed in U.S. Geothermal’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the United States Securities and Exchange Commission and Canadian securities regulatory authorities and in other U.S. Geothermal reports and documents filed with applicable securities regulatory authorities from time to time. Forward-looking statements are based on management’s expectations, beliefs and opinions on the date the statements are made. U.S. Geothermal Inc. assumes no obligation to update forward-looking statements if management’s expectations, beliefs, or opinions, or other factors, should change.
The NYSE MKT does not accept responsibility for the adequacy of this release.
Scott Anderson
Director of Investor Relations and Corporate Communications
U.S. Geothermal Inc.
208-424-1030
208-424-1027
sanderson@usgeothermal.com
$LTRX Preliminary Q2 Data Ahead of 19th Annual #NeedhamGrowthConference
Company Will Report Results for Second Quarter of Fiscal 2017 on Thursday, January 26, 2017
IRVINE, Calif., Jan. 11, 2017 — Lantronix, Inc. (the “Company”) (NASDAQ:LTRX), a global provider of secure data access and management solutions for Internet of Things (IoT) and information technology (IT) assets, today announced preliminary net revenue for its second fiscal quarter ended December 31, 2016.
The Company estimates net revenue for the second quarter of fiscal 2017 to be in the range of $10.9 -$11.1 million, representing year-over-year revenue growth in the range of 14-16%, compared with net revenue of $9.5 million for the second quarter of fiscal 2016.
“We experienced continued momentum with preliminary results showing year-over-year growth in sales in both our IoT and IT management product lines in the December quarter,” said Lantronix CEO Jeff Benck. “I’m grateful to our team for finishing the calendar year strong and demonstrating continued operational execution.”
Lantronix management will be presenting this week at the 19th Annual Needham Growth Conference in New York City. A webcast of the Company’s presentation will be available live on Thursday, January 12, 2017 at 9:20 a.m. Eastern Standard Time (6:20AM Pacific Standard Time) in the investor relations section of the Company’s website at www.lantronix.com.
The Company also announced that it will report its financial results for the fiscal year 2017 second quarter ended December 31, 2016 on January 26, 2017 after the close of the market. Management will host an investor conference call and audio webcast at 5:00 p.m. Eastern Standard Time (2:00 p.m. Pacific Standard Time) on Thursday, January 26, 2017 to discuss the Company’s fiscal year 2017 second quarter results.
To access the live conference call, investors should dial 1-844-802-2442 (US) or 1-412-317-5135 (international) and indicate that they are participating in the Lantronix Q2 FY 2017 call. The webcast will be available simultaneously via the investor relations section of the Company’s website at www.lantronix.com.
Investors can access a replay of the conference call starting at approximately 5:00 p.m. Pacific Standard Time on Thursday, January 26, 2017 at www.lantronix.com. A telephonic replay will also be available through February 2, 2017 by dialing 1-877-344-7529 (US) or 1-412-317-0088 (international) and entering passcode 10099548.
About Lantronix
Lantronix, Inc. is a global provider of secure data access and management solutions for Internet of Things (IoT) and information technology (IT) assets. Our mission is to be the leading supplier of IoT gateways that enable companies to dramatically simplify the creation, deployment, and management of IoT projects while providing secure access to data for applications and people.
With more than two decades of experience in creating robust machine to machine (M2M) technologies, Lantronix is an innovator in enabling our customers to build new business models and realize the possibilities of the Internet of Things. Our connectivity solutions are deployed inside millions of machines serving a wide range of industries, including data center, medical, security, industrial, transportation, retail, financial, environmental and government.
Lantronix is headquartered in Irvine, California, with offices in Europe and Asia. For more information, visit www.lantronix.com.
Learn more at the Lantronix blog, www.lantronix.com/blog, featuring industry discussion and updates. To follow Lantronix on Twitter, please visit www.twitter.com/Lantronix. View our video library on YouTube at www.youtube.com/user/LantronixInc or connect with us on LinkedIn at www.linkedin.com/company/lantronix.
Forward-Looking Statements
This news release contains forward-looking statements, including statements concerning our projected operating and financial performance. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. We have based our forward-looking statements on our current expectations and projections about trends affecting our business and industry and other future events. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial risks and uncertainties that could cause our results or experiences, or future business, financial condition, results of operations or performance, to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this news release. Some of the risks and uncertainties that may cause actual results to differ from those expressed or implied in the forward-looking statements are described in “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, as well as in our other filings with the SEC. In addition, actual results may differ as a result of additional risks and uncertainties of which we are currently unaware or which we do not currently view as material to our business. For these reasons, investors are cautioned not to place undue reliance on any forward-looking statements. The forward-looking statements we make speak only as of the date on which they are made. We expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof to conform such statements to actual results or to changes in our opinions or expectations, except as required by applicable law or the rules of the NASDAQ Stock Market, LLC. If we do update or correct any forward-looking statements, investors should not conclude that we will make additional updates or corrections.
© 2017 Lantronix, Inc. All rights reserved.
Lantronix Contact: E.E. Wang Director, Corporate Marketing and Investor Relations investors@lantronix.com ee.wang@lantronix.com 949-614-5879 Jeremy Whitaker Chief Financial Officer investors@lantronix.com
$KRNT Signs #Agreement with $AMZN
Kornit’s Digital Printing Technology Helps Amazon Expand Its On-Demand Production for Personalized Garment Decoration
ROSH-HA`AYIN, Israel, Jan. 11, 2017 — Kornit Digital (NASDAQ:KRNT), a worldwide market leader in digital textile printing technology, announced today that following previous purchases by Amazon, it has been selected to deliver a large number of on-demand textile production systems to Amazon in support of the company’s Merch by Amazon program.
U.S. online apparel sales in 2015 amounted to $90 billion, according to the Internet Retailer publication, representing 20% year over year growth. As the apparel market transitions to short cycle on demand customized garments, Kornit is focused on providing a fully personalized garment decoration solution with ultra-fast turnaround times.
“We are excited to have been selected as a garment printing solution provider for Amazon, and look forward to the business potential this relationship represents,” said Gabi Seligsohn, CEO of Kornit. “Kornit Digital is at the forefront of the digital direct-to-garment market, and we believe that Amazon’s decision is great testament to that. We are deeply committed to the success of our business with Amazon and reiterate our commitment to all of our customers to stay at the forefront of the DTG market and continue to provide them with the most advanced, cost effective production solutions.”
Through this agreement, Kornit will deliver the company’s flagship high-productivity system, the Avalanche 1000, to support Amazon’s expansion of production capacity for the company’s Merch by Amazon service. A self-service program for developers, Merch by Amazon is the simple way for content creators to increase revenue through the sale of t-shirts.
“Customer demand for graphic t-shirts offered through Merch by Amazon continues to grow rapidly, and more developers and content creators join the service every day,” said Miguel Roque, Director, Merch by Amazon. “Kornit’s ability to deliver solutions and support that meet our high quality and high volume manufacturing requirements will help us to continue expanding program capacity to meet customer requests.”
In conjunction with the commercial agreements, Kornit Digital has agreed to grant Amazon warrants to acquire over a five-year period up to 2,932,176 of Kornit Digital’s common shares at $13.03 per share, based on the volume weighted average closing prices of Kornit Digital common shares for the thirty trading days prior to January 10, 2017. Vesting is tied to payments made by Amazon in connection with the purchase of goods and services from Kornit Digital, the extent of which is more broadly described in a report on Form 6-K filed by Kornit with the SEC earlier today.
About Kornit Digital
Kornit Digital (NASDAQ:KRNT) develops, manufactures and markets industrial digital printing technologies for the garment, apparel and textile industries. Kornit delivers complete solutions, including digital printing systems, inks, consumables, software and after-sales support. Leading the digital direct-to-garment printing market with its exclusive eco-friendly NeoPigment printing process, Kornit caters directly to the changing needs of the textile printing value chain. Kornit’s technology enables innovative business models based on web-to-print, on-demand and mass customization concepts. With its immense experience in the direct-to-garment market, Kornit also offers a revolutionary approach to the roll-to-roll textile printing industry: Digitally printing with a single ink set onto multiple types of fabric with no additional finishing processes. Founded in 2003, Kornit Digital is a global company, headquartered in Israel with offices in the USA, Europe and Asia Pacific, and serves customers in more than 100 countries worldwide. For more information, visit Kornit Digital at www.kornit.com.
Investor contact: Michael Callahan, ICR (203) 682-8311 Michael.Callahan@icrinc.com
$DSCI #Acquires #MEDIHONEY Brand From Long-Term Partner
Secures 10-year Supply Source
Derma Sciences, Inc. (Nasdaq:DSCI), a tissue regeneration company focused on advanced wound and burn care, today announced that it has purchased the MEDIHONEY® brand and related intellectual property and goodwill from its long-term partner, New Zealand-based Comvita Limited. Consideration is an upfront payment of $13.25 million in cash, with an additional $5.0 million potentially payable in the form of an earn-out upon achievement of future annual sales milestones. Prior to the acquisition, Derma Sciences held the exclusive global license for the Comvita-owned MEDIHONEY brand and patents for the medical and professional market segments. The purchase eliminates Derma Sciences’ obligation of royalty payments to Comvita on the sale of MEDIHONEY products, which royalties amounted to $1.6 million in 2016.
Additional agreements entered into at the time of the acquisition include an exclusive medical honey supply agreement from Comvita to Derma Sciences for 10 years with fixed pricing terms for two years, a worldwide licensing agreement from Derma Sciences to Comvita to use the purchased intellectual property in the over-the-counter (OTC) market, and the continued manufacture of honey-based products by Derma Sciences for Comvita for OTC consumer product sales.
“Under Derma’s leadership, the MEDIHONEY brand has grown to be the largest line of medical-grade honey products for advanced wound care use in the world, totaling global sales of approximately $20.0 million in 2016,” said Stephen T. Wills, Executive Chairman of Derma Sciences. “What is important to Derma Sciences and to the healthcare professionals and patients who benefit from these important products, is security of supply. Under the terms of the deal, we have a new 10-year medical honey supply agreement with Comvita, which gives Derma Sciences cost certainty for the first two years and priority of medical honey supply with respect to its needs. Comvita has supplied us for more than a decade, and having the backing of Comvita, its supply chain, and related partnerships gives us the confidence to continue to invest in the growth of our MEDIHONEY business.”
About Derma Sciences, Inc.
Derma Sciences is a tissue regeneration company focused on advanced wound and burn care. It is engaged in the development and commercialization of novel proprietary regenerative products derived from placental/birth tissues for use in a broad range of clinical applications including the treatment of complex chronic wounds, acute wounds and localized areas of injury or inflammation, in addition to filling soft tissue defects or voids. The Company also markets TCC-EZ®, a gold-standard total contact casting system for diabetic foot ulcers. Derma Sciences’ MEDIHONEY® product line is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for barrier protection against microbes and other contaminants. The Company also offers a full product line of traditional dressings. For more information, please visit www.dermasciences.com.
Forward-Looking Statements
Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate” or “continue” are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release or that are otherwise made by or on behalf of the Company. Factors that may affect the Company’s results include, but are not limited to product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the Company’s actual results and forward-looking statements include but are not limited to, those discussed in the Company’s filings with the U.S. Securities and Exchange Commission.
Derma Sciences, Inc.
John Yetter, 609-514-4744
Chief Financial Officer
jyetter@dermasciences.com
or
Investors
LHA
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
$EXPI Nearly Triples #RealEstate #Agent Count in 2016
Over 1,500 Real Estate Professionals Joined eXp Realty in 2016 for a Total of 2,401
BELLINGHAM, WA–(January 11, 2017) – eXp World Holdings, Inc. (OTCQB: EXPI), the holding company for eXp Realty LLC, The Agent-Owned Cloud Brokerage®, announced today the Company ended 2016 with 2,401 real estate brokers and agents on its platform, representing an increase 1,537, or 178%, when compared to 864 at the end of 2015.
eXp Realty has now grown its family of agents and brokers across 42 states and D.C. in the U.S., as well as Alberta, Canada. The Company continues to attract top talent with its unique agent-centric model that allows agents and brokers to build their own businesses, while establishing a direct ownership interest the Company as a shareholder and partner.
“Our rapid growth in 2016 not only exceeded our goal of 2,200 agents by year-end, but also established us as one of the fastest growing brokerages in North America,” said Glenn Sanford, Founder, CEO and Chairman of eXp World Holdings, Inc. “Our model has resonated with quality real estate professionals, allowing us to attract some of the top producing agents as well as some of the highest ranking teams throughout the U.S. and Canada. These entrepreneurial, high-achieving professionals recognize agent ownership as a fundamental shift in the relationship between the agent and the brokerage firm. Looking ahead to 2017, we expect to continue our accelerated growth rate in both agent count and revenues as a result of our unique commitment to agent ownership, support and engagement.”
About eXp World Holdings, Inc.
eXp World Holdings, Inc. (OTCQB: EXPI) is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage®. As a full-service real estate brokerage, eXp Realty LLC provides 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers real estate professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information, please visit the Company’s Twitter, LinkedIn, Facebook, YouTube, or visit www.eXpWorldHoldings.com. For eXp Realty please visit: www.eXpRealty.com.
Safe Harbor Statement
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Investor Relations Contact:
Greg Falesnik
Managing Director
MZ Group – MZ North America
949-385-6449
Email contact
www.mzgroup.us
Media Contact:
Russ Cofano
President
eXp World Holdings, Inc.
573-825-0780
Email contact
Trade Contact:
Jason Gesing
CEO
eXp Realty, LLC
617-970-8518
Email contact
$SRPT #LicenseAgreement with Nationwide Children’s Hospital, #Galgt2 #GeneTherapy
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial stage developer of innovative RNA-targeted therapeutics, today announced it has entered an exclusive license agreement with Nationwide Children’s Hospital, for their Galgt2 gene therapy program developed by researcher Dr. Paul Martin, Ph.D.
“We are taking a multi-front approach in the battle against Duchenne muscular dystrophy,” said Edward Kaye, Sarepta’s chief executive officer. “We find this therapeutic approach to be of particular interest as it has the potential to treat all patients suffering from the disease regardless their mutation.”
The experimental program explores the potential surrogate gene therapy approach to Duchenne muscular dystrophy. As a “surrogate gene therapy approach”, the gene therapy looks to induce genes that make proteins that can perform a similar function as dystrophin, with the goal of producing a muscle cell that can function normally even when dystrophin is absent. It has the potential to be used broadly in several muscular dystrophies.
“We are pleased to have this opportunity to help advance our Galgt2 gene therapy program,” said Dr. Kevin Flanigan, the Principal Investigator leading the clinical trial. “Our goal is to have this program in the clinic during 2017 and begin to evaluate a therapy that has the potential to treat patients of all ages and disease severity.”
About Sarepta Therapeutics
Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at www.sarepta.com.
About The Research Institute at Nationwide Children’s Hospital
Named to the Top 10 Honor Roll on U.S. News & World Report’s 2016-17 list of “America’s Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric healthcare systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s faculty train the next generation of pediatricians, scientists and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded free-standing pediatric research facilities in the U.S., supporting basic, clinical, translational and health services research at Nationwide Children’s. The Research Institute encompasses three research facilities totaling 525,000 square feet dedicated to research. More information is available at NationwideChildrens.org/Research.
Forward-Looking Statements
This press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements about the exclusive license agreement Sarepta has entered into with Nationwide Children’s Hospital for their Galgt2 gene therapy program, the potential for this therapeutic approach to treat all patients suffering from DMD regardless of their mutation, age and disease severity, the expected clinical progress of the program in 2017, the potential for the gene therapy to be used in several muscular dystrophies, the gene therapy’s mechanism of action and potential efficacy and Sarepta taking a multi-front approach in the battle against DMD.
These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the expected benefits and opportunities related to the exclusive license agreement and related agreements between the parties may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development; the partnership between Sarepta and Nationwide Children’s hospital may not result in any viable treatments suitable for clinical research or commercialization due to a variety of reasons including that the results of additional research may not be consistent with past results or may not be positive or may otherwise fail to meet regulatory approval requirements for the safety and efficacy of product candidates or may never become commercialized products due to other various reasons including any potential future inability of the parties to fulfill their commitments and obligations under the agreements; and even if the agreements result in commercialized products, the parties may not achieve any significant revenues from the sale of such products.
Any of the foregoing risks could adversely affect Sarepta’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review Sarepta’s 2015 Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Internet Posting of Information
We routinely post information that may be important to investors in the ‘For Investors’ section of our web site at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.
Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com
or
W2O Group
Brian Reid, 212-257-6725
breid@w2ogroup.com
$XGTI Regains #Compliance with @Nasdaq #ListingRequirements
SARASOTA, Fla., Jan. 10, 2017 — xG Technology, Inc. (“xG” or the “Company”) (Nasdaq: XGTI, XGTIW), a leader in providing critical wireless communications for use in challenging operating environments, announced today that the Company has regained full compliance with all listing requirements of the Nasdaq Stock Market (“Nasdaq”).
In a letter received from the Listing Qualifications Department of Nasdaq on January 9, 2017, the Company was informed that it has regained compliance with the bid price and rights/warrants rules, as required by the Panel’s decision dated November 21, 2016, and is in compliance with other applicable requirements as set forth in the decision and required for listing on The Nasdaq Capital Market. Accordingly, the Panel has determined to continue the listing of the Company’s securities on The Nasdaq Stock Market and is closing this matter.
About xG Technology, Inc.
Founded in 2002, xG Technology has developed technologies that enable always-available, always-connected and always-secure voice, broadband data and video communications. The company’s brand portfolio includes xMax and Integrated Microwave Technologies (IMT).
xMax is a patented all-IP, software-defined cognitive radio network that delivers mission-assured wireless connectivity in any RF environment. It provides a solution to the challenges of interoperability, survivability and flexibility in expeditionary and critical communications networks. xMax incorporates advanced optimizing technologies that include spectrum sharing, interference mitigation, multiple-input multiple-output (MIMO) and software defined radio (SDR), making it ideal for wide area, as well as rapid emergency communication deployment in unpredictable environments and during fluid situations. xMax offers solutions for numerous industries worldwide, including military, emergency response and public safety, telemedicine and critical infrastructure.
IMT is a leading provider of mission-critical video solutions, advanced digital microwave systems and engineering, integration, installation and commissioning services serving the Broadcast, Sports & Entertainment and MAG (Military, Aerospace & Government) markets. Since its inception, IMT has focused on building a product portfolio that incorporates a high level of performance, reliability and build quality, extended operating ranges and compact form factors. IMT’s product lines include digital broadcast microwave video systems, compact microwave video equipment for licensed and license-free sports and entertainment applications, and wireless video solutions designed for use by state, local and federal police departments. More information on IMT can be found at www.imt-solutions.com.
Based in Sarasota, Florida, xG has over 100 patents and pending patent applications. xG is a publicly traded company listed on the NASDAQ Capital Market (symbol: XGTI) For more information, please visit www.xgtechnology.com
Cautionary Statement Regarding Forward Looking Statements
Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to xG Technology, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.
For More Information:
Daniel Carpini
xG Technology
daniel.carpini@xgtechnology.com
(941) 953-9035
$ONTX Discusses Target Indications and Clinical Development w/ StockNewsNow.com
LOS ANGELES, Jan. 10, 2017 — StockNewsNow.com, The Official MicroCap News Source™, today published an SNNLive Video Interview with Ramesh Kumar, President & CEO of Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with primary focus on Myelodysplastic Syndromes, according to the Company’s website (see here: www.onconova.com). The video interview was recorded on Wednesday, December 7th, 2016 at the LD Micro “Main Event” 2016 in Bel Air, CA.
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About Onconova Therapeutics, Inc.
Onconova Therapeutics is a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with primary focus on Myelodysplastic Syndromes. Onconova’s clinical and pre-clinical stage drug development candidates are derived from its extensive chemical library and are designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. The Company’s most advanced product candidate, rigosertib, is a small molecule inhibitor of cellular signaling and acts as a RAS mimetic. These effects of rigosertib appear to be mediated by direct binding of the compound to the RAS-binding domain (RBD) found in many RAS effector proteins, including the Raf and PI3 kinases. Rigosertib is protected by issued patents (earliest expiry in 2026) and has been awarded Orphan Designation for MDS in the United States, Europe and Japan. In addition to rigosertib, two other candidates are in the clinical stage, and several candidates are in pre-clinical stages. For more information, please visit http://www.onconova.com.
The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trial involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 global INSPIRE trial as 2nd-line treatment for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is suited for patients with advanced disease and provides long duration of exposure and ensures adequate dosing under a controlled setting.
The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial. INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first nine months of initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).
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$BIOC Secures In-Network #ProviderAgreement with #BlueCrossBlueShieldofTexas #BCBSTX
SAN DIEGO, Jan. 10, 2017 — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of clinically actionable liquid biopsy tests designed to improve the outcomes of cancer patients, announces that it has secured an in-network provider agreement with Blue Cross Blue Shield of Texas (BCBSTX), the largest provider of health benefits in that state.
“Determining the molecular status of a tumor can help physicians individualize treatment for their patients and our highly sensitive Target Selector™ platform can provide this important information from a simple blood sample,” said Biocept’s Senior Vice President and Senior Medical Director Veena Singh, MD. “Our liquid biopsy testing is changing the way physicians evaluate tumor status and monitor both response and resistance to treatment.”
“It is gratifying that health plans are seeing the value of our liquid biopsy approach for profiling and monitoring important cancer biomarkers,” said Michael Nall, President and Chief Executive Officer of Biocept. “Partnering with health insurers is a major focus of our business strategy, as it may increase physician access to this non-invasive technology for their patients and provide timely adjudication of claims for patients. Securing this in-network agreement is an important milestone for Biocept, as Texas is one of our largest markets and BCBSTX is the largest provider in that state. With this agreement, the number of patients with in-network access to our tests has grown to approximately 185 million, with some members having access via multiple plans.”
About Biocept
Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with information for treating and monitoring patients diagnosed with cancer. The Company’s patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in plasma (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient’s disease and therapeutic options. For additional information, please visit www.biocept.com.
Forward-Looking Statements Disclaimer Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the diagnosis and treatment of cancer, our ability to increase physician access to our technology, and our ability to provide timely adjudication of claims, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.
$EXEL Update on Dispute with $RHHBY Group Member #Genentech
— Genentech withdraws counterclaim —
— Exelixis relieved of $18.7 million of disputed costs —
— Genentech’s unilateral action does not otherwise resolve the dispute —
Exelixis, Inc. (Nasdaq:EXEL) announced today that Genentech, Inc. has withdrawn its counterclaim against Exelixis in the ongoing JAMS arbitration concerning alleged breaches of the parties’ collaboration agreement. Genentech had asserted a counterclaim for breach of contract, which sought monetary damages and interest related to cost allocations under the collaboration agreement. When notifying the arbitral panel, and Exelixis, of this unilateral action, Genentech further stated that it is changing the manner in which it allocates promotional expenses of the COTELLIC® (cobimetinib) plus Zelboraf® (vemurafenib) combination therapy.
As a result of Genentech’s decision to change its cost allocation approach, Exelixis is relieved of $18.7 million of disputed costs previously charged by Genentech. Exelixis has invoiced Genentech an additional $7.1 million with interest for expenses that Exelixis paid previously.
Genentech’s revised allocation applies retrospectively and prospectively and will substantially reduce Exelixis’ exposure to costs associated with promotion of the COTELLIC + Zelboraf combination in the United States. Exelixis and Genentech have shared promotional costs since commercial activities were initiated in early 2013. As detailed in previous regulatory filings, Exelixis charged its Profit and Loss Statement approximately $38 million for promotional costs through the third quarter of 2016. With the new approach that Genentech has adopted unilaterally, Exelixis’ liability for promotional costs will be reduced to approximately $15 million for the same period.
Other significant issues remain in dispute between the parties. Genentech’s action does not address the claims in Exelixis’ Demand for Arbitration related to Genentech’s clinical development, pricing and promotional costs for COTELLIC in the United States, nor does it fully resolve claims over revenue allocation. And, Genentech has not confirmed how it intends to allocate promotional costs incurred with respect to the collaboration’s promotion of other combination therapies that include cobimetinib for other indications that are in development and may be approved. Exelixis will continue to press its position before the arbitral panel to obtain a just resolution of these claims and the clarity it requires.
About the Dispute
On June 3, 2016, Exelixis filed a Demand for Arbitration before JAMS in San Francisco, California asserting claims against Genentech related to its clinical development, pricing and promotion of COTELLIC, and cost and revenue allocations in connection with COTELLIC’s promotion in the United States. The arbitration demand asserts that Genentech has breached the parties’ contract by, amongst other breaches, failing to meet its diligence and good faith obligations. The demand seeks various forms of declaratory, monetary, and equitable relief, including without limitation that the cost and revenue allocations for COTELLIC be shared equitably consistent with the collaboration agreement’s terms, along with attorneys’ fees and costs of the arbitration. Genentech had asserted a counterclaim for breach of contract, which sought monetary damages and interest related to the cost allocations under the collaboration agreement.
About Exelixis
Exelixis, Inc. (Nasdaq: EXEL) is a biopharmaceutical company committed to the discovery, development and promotion of new medicines with the potential to improve care and outcomes for people with cancer. Since its founding in 1994, three medicines discovered at Exelixis have progressed through clinical development to receive regulatory approval. Currently, Exelixis is focused on advancing cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL and VEGF receptors, which has shown clinical anti-tumor activity in more than 20 forms of cancer and is the subject of a broad clinical development program. Two separate formulations of cabozantinib have received regulatory approval to treat certain forms of kidney and thyroid cancer and are marketed for those purposes as CABOMETYX™ tablets (U.S. and EU) and COMETRIQ® capsules (U.S. and EU), respectively. Another Exelixis-discovered compound, COTELLIC® (cobimetinib), a selective inhibitor of MEK, has been approved in major territories including the United States and European Union, and is being evaluated for further potential indications by Roche and Genentech (a member of the Roche Group) under a collaboration with Exelixis. For more information on Exelixis, please visit www.exelixis.com or follow @ExelixisInc on Twitter.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ position that Genentech’s revised allocation approach will substantially reduce Exelixis’ exposure to costs associated with promotion of the COTELLIC + Zelboraf combination in the United States; Exelixis’ plan to continue to press its position before the arbitral panel to obtain a just resolution of the issues remaining in dispute with Genentech; Exelixis’ commitment to the discovery, development and promotion of new medicines with the potential to improve care and outcomes for people with cancer; Exelixis’ focus on advancing cabozantinib; and the continued development of cobimetinib. Words such as “will,” “may,” “committed,” “focused,” “potential,” or other similar expressions identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: that Genentech/Roche may not account for promotional expenses in accordance with Exelixis’ expectations; Exelixis’ dependence on its relationship with Genentech/Roche with respect to cobimetinib and ability to maintain its rights under the collaboration; risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 3, 2016, and in Exelixis’ future filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Exelixis, the Exelixis logo, COMETRIQ and COTELLIC are registered U.S. trademarks, and CABOMETYX is a U.S. trademark.
Exelixis, Inc.
Susan Hubbard, 650-837-8194
EVP, Public Affairs and Investor Relations
shubbard@exelixis.com
or
For Exelixis, Inc.
Hal Mackins, 415-994-0040
hal@torchcomllc.com
$RAVE Restaurant Group Names #ScottCrane as #CEO
DALLAS, Jan. 9, 2017 — RAVE Restaurant Group, Inc. (NASDAQ:RAVE) today announced that the Board of Directors has named Scott Crane as Chief Executive Officer, effective today. Crane succeeds Interim CEO Clinton J. Coleman, who will remain in his role as a member of the Board, where he has served since 2007.
“Scott is dynamic leader with a proven track record of growth with success,” said Mark Schwarz, Chairman of RAVE Restaurant Group, Inc. “An entrepreneur at an early age, Scott’s restaurant industry focus has led to a succession of managerial roles of progressively greater responsibility and achievement throughout his career, including most recently growing the Smashburger concept from scratch to a thriving, profitable business that led to its highly successful transaction with Jollibee Foods Corporation last year at an enterprise valuation of $335 million. Scott is an exceptional leader who will contribute greatly to the culture, growth and success at Rave. I am confident his expertise and keen understanding of the fast casual category will be a true asset to the continuing development of our Company.”
Crane most recently served as President and Chief Executive Officer of the high-growth fast casual dining company Smashburger, where he led its development from a two-unit start up concept in 2007 to a global company with more than 330 corporate and franchise locations operating in 35 states and seven countries with annual sales in excess of $350 million at the time of his departure in 2016. Previously, Mr. Crane was at Fugate Enterprises, Inc., one of the largest Pizza Hut franchisees in the country, where he was responsible for the operation of 210 Pizza Hut units, in addition to Taco Bell, Wing Street, Sonic and Blockbuster Video locations.
“Under Scott’s leadership, Smashburger has been broadly credited as being the leading fast casual brand in ‘better burger’ segment, receiving numerous business and consumer accolades including Forbes No. 1 Most Promising Company, Inc. 500 list of fastest growing private companies, Technomic’s #1 Social Media Brand and numerous “top” franchisor awards,” said Clinton Coleman, Board Member and Interim CEO at RAVE Restaurant Group, Inc. “To support the Company’s continued growth under Scott’s leadership, RAVE recently announced a $3 million capital raise by way of a registered rights offering, which is projected to be completed in February 2017.”
“I am excited to be joining RAVE at this particular time and look forward to leading it into the next phase of success and delivering results for its guests, employees, franchisees and all stakeholders,” said Crane. “I look forward to working with the Rave team as we unlock the enormous potential of the Pie Five concept and continue to introduce consumers to the new and growing category of fast casual pizza. I also have tremendous respect for and am excited to lead Pizza Inn, a brand rich with tradition that has served more than three generations of American families.”
About RAVE Restaurant Group, Inc.
Founded in 1958, Dallas-based RAVE Restaurant Group [NASDAQ: RAVE] owns, operates and franchises more than 300 Pie Five Pizza Co. and Pizza Inn restaurants domestically and internationally. Pie Five Pizza Co. is a leader in the rapidly growing fast-casual pizza space offering made-to-order pizzas ready in under five minutes. Pizza Inn is an international chain featuring freshly made pizzas, along with salads, pastas, and desserts. The Company’s common stock is listed on the Nasdaq Capital Market under the symbol “RAVE”. For more information, please visit www.raverg.com.
Contact:
Jami Zimmerman
RAVE Restaurant Group, Inc.
469-384-5132
$CTIC Announces Progress Of Lead Programs And Strategic Objectives For 2017
SEATTLE, Jan. 9, 2017 — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced positive progress on its lead programs in addition to key business priorities for 2017.
“Throughout 2016 we maintained our commitment to bringing new therapies to patients with unmet medical needs, and were successful in working with the FDA to remove the full clinical hold on pacritinib and get it back on the development track for the benefit of myelofibrosis patients,” said Richard Love, Interim President and Chief Executive Officer of CTI BioPharma. “The PERSIST-2 clinical trial of pacritinib was highlighted as one of six late-breaking data presentations at the American Society of Hematology conference in December. We believe this oral presentation was well received by the hematology/oncology community, which recognizes the unmet need for myelofibrosis patients who are ineligible to receive or are not benefitting from the approved JAK1/JAK2 inhibitor, ruxolitinib. Additionally, the PIX306 confirmatory trial of our commercial product PIXUVRI(R)(pixantrone) continues to progress toward an announcement of top-line results later this year. If positive, this trial could provide the opportunity for full approval and label expansion by EMA, and discussions with the FDA about accelerated PIXUVRI approval in the US for the treatment of patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. We have also made significant effort at reducing our expenses and believe we are well positioned moving into 2017.”
Recent Progress Update
Pacritinib
In January 2017, CTI BioPharma announced the U.S. Food and Drug Administration (FDA) removed the full clinical hold on studies being conducted under the Investigational New Drug (IND) application for pacritinib.
In December 2016, data from the randomized Phase 3 PERSIST-2 clinical trial comparing pacritinib with physician-specified best available therapy (BAT), including ruxolitinib, for treatment of patients with myelofibrosis whose baseline platelet counts are less than 100,000 per microliter was one of six late-breaking oral presentations at the American Society of Hematology Annual Meeting. Patients in the trial were randomized to receive 200 mg pacritinib twice daily (BID), 400 mg pacritinib once daily (QD), or BAT. In those patients who had a chance to reach Week 24 (the primary analysis time point) at the time the clinical hold was imposed, the trial showed a statistically significant response rate in spleen volume reduction (SVR) in patients treated with pacritinib compared to BAT irrespective of prior treatment with ruxolitinib. The co-primary endpoint of reduction of Total Symptom Score (TSS) was not achieved but trended toward improvement in TSS. Although secondary objectives could not be evaluated formally due to the study not achieving one of the primary objectives, when the two pacritinib dosing arms were evaluated separately versus BAT, pacritinib BID showed a higher percent of SVR and TSS responses compared to BAT; whereas, pacritinib given QD showed only a higher percent SVR responses compared to BAT. There was no significant difference in overall survival (OS) across treatment arms, censored at the time of clinical hold. The most common treatment-emergent adverse events (AEs), occurring in 20 percent or more of patients treated with pacritinib within 24 weeks, of any grade, were gastrointestinal (generally manageable diarrhea, nausea and vomiting) and hematologic (anemia and thrombocytopenia) and were generally less frequent for BID versus QD administration. The most common serious treatment-emergent AEs (incidence of ≥5 percent reported in any treatment arm irrespective of grade) were anemia, thrombocytopenia, pneumonia and acute renal failure none of which exceeded 8 percent individually in any arm. The presentation was also selected to be part of the “2017 Highlights of ASH” program designed to review significant scientific updates presented at ASH with hematologists/oncologists at five locations across the U.S.
PIXUVRI®
In January 2017, CTI BioPharma received a €7.5 million milestone payment from its partner Servier following achievement of a milestone associated with patient enrollment in the Phase 3 PIX306 clinical trial of PIXUVRI. The trial is a post-authorization trial as part of the conditional marketing authorization of PIXUVRI in the European Union (E.U.) The PIX306 is comparing PIXUVRI and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell non-Hodgkin lymphoma (NHL). The trial continues to enroll patients.
2017 Key Objectives
Advance Marketing Authorization Application in E.U. and define regulatory pathway in U.S. for pacritinib. CTI BioPharma continues to have dialogue with the European Medicines Authority (EMA) on the Marketing Authorization Application (MAA) for pacritinib that had been previously filed by its former partner, Baxalta. At the time of the filing only data from the first Phase 3 clinical trial of pacritinib, PERSIST-1, was available. With the availability of results from the PERSIST-2 clinical trial and the recent completion of the PERSIST-2 clinical study report, CTI BioPharma believes that the best strategy currently to achieve marketing authorization is to utilize the combined clinical evidence from both Phase 3 trials. Accordingly, CTI BioPharma is evaluating whether to update the current application with the additional data from PERSIST-2 or to resubmit the MAA. Under either plan, CTI BioPharma would expect to pursue marketing authorization for the treatment of patients with myelofibrosis who are ineligible to receive, intolerant of or have insufficient response to the approved JAK1/JAK2 inhibitor, ruxolitinib.
CTI BioPharma also intends to discuss with the FDA the future development of pacritinib.
Initiate PAC203 trial. CTI BioPharma expects to initiate the PAC203 trial in the second quarter of 2017. The trial plans to enroll up to approximately 105 patients with primary myelofibrosis who have failed prior ruxolitinib therapy to evaluate the safety and the dose response relationship for efficacy (spleen volume reduction at 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID.
Secure ex-U.S. partner for pacritinib. CTI BioPharma intends to secure a partnership for the development and commercialization of pacritinib in certain territories outside the U.S.
Release top-line results of PIX306. CTI BioPharma expects to complete enrollment in the ongoing PIX306 trial of PIXUVRI and release top-line results by the end of 2017.
Financial
CTI BioPharma’s preliminary, unaudited estimates of its cash and cash equivalents balance as of December 31, 2016 is approximately $44.0 million. In January 2017, we received a €7.5 million milestone payment from Servier. CTI BioPharma expects that its cash burn (a non-GAAP financial measure), excluding cash inflows from future business development activities and proceeds from capital markets financing activities, would be approximately $65-75 million for 2017. The Company expects to meet its cash requirements for 2017 with existing cash and by partnering one or more product assets during the course of the year.
About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia, or AML, myelodysplastic syndrome, or MDS, chronic myelomonocytic leukemia, or CMML, and chronic lymphocytic leukemia, or CLL, due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.
In August 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high risk myelofibrosis including, but not limited to, patients with disease-related thrombocytopenia (low platelet counts); patients experiencing treatment-emergent thrombocytopenia on other JAK2 inhibitor therapy; or patients who are intolerant of, or whose symptoms are not well controlled (sub-optimally managed) on other JAK2 therapy.
Pacritinib was evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis, with one trial in a broad set of patients without limitations on platelet counts, the PERSIST-1 trial; and the other in patients with low platelet counts, the PERSIST-2 trial. The PERSIST-1 trial met its primary endpoint of spleen volume reduction (35 percent or greater from baseline to Week 24 by MRI/CT scan). The PERSIST-2 trial met one of its co-primary endpoints, that of spleen volume reduction. The co-primary endpoint of reduction of Total Symptom Score (TSS) was not achieved but trended toward improvement in TSS.
Clinical studies under the investigational new drug (IND) for pacritinib were subject to a full clinical hold issued by the FDA in February 2016. In January 2017, the FDA removed the full clinical hold and stated that clinical trials may be resumed.
About PIXUVRI® (pixantrone)
PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. In May 2012, the European Commission granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory B-cell aggressive NHL. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.pixuvri.eu. PIXUVRI does not have marketing approval in the United States.
In September 2014, CTI BioPharma entered into an exclusive license and collaboration agreement, with Servier with respect to the development and commercialization of PIXUVRI. Under the agreement, CTI BioPharma retains full commercialization rights to PIXUVRI in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, the United Kingdom and the U.S. while Servier has exclusive rights to commercialize PIXUVRI in all other countries.
About CTI BioPharma
CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a commercial presence in Europe with respect to PIXUVRI® and a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington, with offices in London and Milan under the name CTI Life Sciences Limited. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI BioPharma’s securities. Such statements include, but are not limited to, expectations with respect to our ability to be able to interpret clinical trial data and results despite not satisfying the pre-specified minimum evaluable patient goal, expectations with respect to the potential therapeutic utility of pacritinib, including pacritinib’s potential to achieve treatment goals across patients with myelofibrosis, regardless of baseline characteristics, and statements regarding CTI BioPharma’s expectations with respect to the development of CTI BioPharma, its financial position and its product and product candidate portfolio, including strategies and plans for achieving marketing authorization and other approvals, partnerships, and the initiation or completion of clinical strials. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. In particular, meaningful interpretation of PERSIST-2 may not be possible because the pre-specified minimum evaluable patient goal was not met. The statements are based on assumptions about many important factors and information currently available to us to the extent we have thus far had an opportunity to fully and carefully evaluate such information in light of all surrounding facts, circumstances, recommendations and analyses. Risks that contribute to the uncertain nature of the forward-looking statements include, among others: risks associated with the biopharmaceutical industry in general and with CTI BioPharma and its product and product candidate portfolio in particular, risks associated with the pace or geography of enrollment of its clinical trials, risks associated with the commencement or outcome of preclinical and clinical studies, that trial results observed to date may differ from future results or that different conclusions or considerations may qualify such results once existing data has been more fully evaluated, that CTI BioPharma may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities or will not be in a position to submit regulatory submissions as or when projected, risks related to the actions of regulatory bodies and other governmental authorities, risks related to changes in laws and regulations, product quality, product efficacy, study protocol, data integrity or patient safety issues, risks related to the costs of developing, producing and selling PIXUVRI, pacritinib and CTI BioPharma’s other product candidates, and other risks, including, without limitation, competitive factors, technological developments, and that CTI BioPharma may not achieve previously announced goals and objectives as or when projected as well as other risks listed or described from time to time in CTI BioPharma’s most recent filings with the SEC on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI BioPharma does not intend to update any of the statements in this press release upon further developments.PIXUVRI is a registered trademark of CTI BioPharma Corp.
CTI BioPharma Contacts:
Ed Bell
+1 206-272-4345
ebell@ctibiopharma.com
$WOOF to #Acquire #VCA
All-cash transaction valued at approximately $9.1 billion VCA shareholders to receive $93 per share of VCA common stock VCA to be a separate business unit within Mars Petcare
MCLEAN, Va. and LOS ANGELES, Jan. 9, 2017 — Mars, Incorporated and VCA Inc. (NASDAQ:WOOF) today announced that they have entered an agreement under which Mars will acquire all of the outstanding shares of VCA for $93 per share, or a total value of approximately $9.1 billion including $1.4 billion in outstanding debt. The transaction price represents a premium of approximately 41 percent over VCA’s 30-day volume weighted average price on January 6, 2017, and a premium of approximately 31 percent over VCA’s closing price on January 6, 2017. The agreement has been unanimously approved by the boards of directors of both companies.
VCA joins Mars Petcare, one of the world’s leading pet care providers. Pet care has been an important part of Mars for over 80 years. The transaction reaffirms Mars’ commitment to the pet care industry and the veterinary profession, and once completed will help drive Mars Petcare’s purpose to create A Better World for Pets. Mars Petcare’s portfolio of Veterinary Services businesses includes BANFIELD® Pet Hospital, BLUEPEARL® and PET PARTNERS™. Together with VCA, these businesses will provide an unprecedented level of access to high quality veterinary care for pets, from wellness and prevention to primary, emergency and specialty care. Mars Petcare is already an industry leader in pet nutrition with global brands that include ROYAL CANIN®, PEDIGREE® and WHISKAS®. Mars has a growing business in pet DNA testing through the WISDOM PANEL®, and in 2015 also acquired pet technology provider WHISTLE.
“We are thrilled to welcome VCA to the Mars family and to our portfolio of brands and businesses around the world,” said Mars Chief Executive Officer Grant F. Reid. “VCA is a leader across pet health care and the opportunity we see together—for pets, pet owners, veterinarians and other pet care providers —is tremendous. We have great respect for VCA, with whom we share many common values and a strong commitment to pet care. Together, we will be able to provide even greater value, better service and higher quality care to pets and pet owners.”
Since its founding in 1986, VCA has grown from one facility in Los Angeles to nearly 800 animal hospitals with 60 diagnostic laboratories throughout the United States and Canada. Through organic growth and a series of acquisitions, VCA has become one of the largest and most diverse pet healthcare companies, operating across four divisions including veterinary services, laboratory diagnostics, imaging equipment and medical technology, and pet care services.
“Joining the Mars family of brands provides significant value to our stockholders while also preserving the Company’s values and a culture focused on investing in our people and facilities to promote excellence in pet care and long-term growth,” said VCA Chief Executive Officer Bob Antin. “Mars has a long-standing commitment to pet health, wellness and nutrition. We will work together every day to continue to provide the quality care and excellent service VCA is known for to our clients and their pet families.”
“We have always been impressed by VCA and the excellent services it offers to pets across diverse business segments,” said Mars Global Petcare President Poul Weihrauch. “VCA’s industry-leading partnerships with veterinarians and pet care providers together with its expertise in veterinary services, diagnostics and technology will position Mars to deliver accessible, quality care and continue to create a better world for pets. VCA’s philosophy of partnering with the veterinary profession and educational institutions is aligned with our core values and culture. We look forward to together providing the best care possible for pets.”
As one of the world’s leading pet care providers, Mars Petcare is committed to attracting, developing and retaining the best veterinarians and pet care professionals in the world, supporting them in their efforts to provide cutting edge delivery of healthcare to pets and to advancing the profession.
VCA to be a distinct and separate business unit within Mars Petcare
Upon completion of the transaction, VCA will operate as a distinct and separate business unit within Mars Petcare, alongside its other Veterinary Services businesses, BANFIELD® Pet Hospital, BLUEPEARL® and PET PARTNERS™, and will continue to be led by Bob Antin, Chief Executive Officer, President, Chairman and a founder of VCA. The company will remain headquartered in Los Angeles, California and will remain focused on its business model and strategic objectives.
Closing Conditions
The transaction is subject to certain customary closing conditions, including, among other things, VCA shareholder approval and customary regulatory approvals. Mars has committed financing for the purchase of VCA. We expect the transaction to close in Q3 2017.
Advisors
Morgan Stanley & Co. LLC and BDT & Co. are Mars’ financial advisors, and Skadden, Arps, Slate, Meagher & Flom is providing legal advice on the acquisition, with Simpson Thacher & Bartlett providing legal advice for the debt financing and McDermott Will & Emery assisting on antitrust matters. J.P. Morgan is providing financing to Mars for the transaction.
Barclays is acting as exclusive financial advisor to VCA, and Akin Gump Strauss Hauer & Feld LLP and Potter Anderson Corroon LLP are serving as legal advisors.
About Mars, Incorporated
Based in McLean, Virginia, Mars has net sales of more than $35 billion, six business segments including Petcare, Chocolate, Wrigley, Food, Drinks, Symbioscience, and more than 80,000 Associates worldwide that are putting its Principles into action to make a difference for people and the planet through its performance. Mars brands include: Petcare – PEDIGREE®, ROYAL CANIN®, WHISKAS®, BANFIELD® Pet Hospital, CESAR®, SHEBA®, DREAMIES® and NUTRO®; Chocolate – M&M’S®, SNICKERS®, DOVE®, GALAXY®, MARS®, MILKY WAY® and TWIX®; Wrigley – DOUBLEMINT®, EXTRA®, ORBIT® and 5™ chewing gums, SKITTLES® and STARBURST® candies, and ALTOIDS® AND LIFESAVERS® mints. Food – UNCLE BEN’S®, DOLMIO®, EBLY®, MASTERFOODS®, SEEDS OF CHANGE® and ROYCO®; Drinks – ALTERRA COFFEE ROASTERS™, THE BRIGHT TEA COMPANY™, KLIX® and FLAVIA®; Symbioscience – COCOAVIA® and WISDOM PANEL®.
For more information, please visit mars.com. Follow us: facebook.com/mars, twitter.com/marsglobal, youtube.com/mars, linkedin.com/company/mars
About VCA Inc.
VCA is a leading provider of pet health care services in the country delivered through nearly 800 small animal veterinary hospitals in the US and Canada, a preeminent nationwide clinical laboratory system that services all 50 states and Canada (Antech Diagnostics), the leading animal diagnostic imaging company in the market (Sound), and Camp Bow Wow (CBW), the nation’s Premier Doggy Day and Overnight Camp® franchise.
Forward Looking Statements
This document contains forward-looking statements within the meaning of the securities laws with respect to the proposed transaction between the Company, Mars and certain subsidiaries of Mars. We have included herein statements that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We generally identify forward-looking statements in this document using words like “believe,” “intend,” “expect,” “estimate,” “may,” “plan,” “should,” “could,” “forecast,” “looking ahead,” “possible,” “will,” “project,” “contemplate,” “anticipate,” “predict,” “potential,” “continue,” or similar expressions. You may find some of these statements below and elsewhere in this document. These forward-looking statements are not historical facts and are inherently uncertain and outside of our control. Any or all of our forward-looking statements in this document may turn out to be incorrect. They can be affected by inaccurate assumptions we might make, or by known or unknown risks and uncertainties. Many factors mentioned in our discussion in this document will be important in determining future results. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect the Company’s business and the price of the common stock of the Company; (ii) the failure to satisfy or obtain waivers of the conditions to the consummation of the proposed transaction, including the adoption of the merger agreement by the stockholders of the Company and the receipt of certain governmental and regulatory approvals; (iii) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (iv) the effect of the announcement or pendency of the proposed transaction on the Company’s business relationships, operating results and business generally; (v) risks that the proposed transaction disrupts current plans and operations of the Company, including the risk of adverse reactions or changes to business relationships with customers, suppliers and other business partners of the Company; (vi) potential difficulties in the hiring or retention of employees of the Company as a result of the proposed transaction; (vii) risks related to diverting management’s attention from the Company’s ongoing business operations; (viii) potential litigation relating to the merger agreement or the proposed transaction; (ix) unexpected costs, charges or expenses resulting from the proposed transaction, (x) competitive responses to the proposed transaction; and (xi) legislative, regulatory and economic developments.
The foregoing list of factors is not exclusive. Additional risks and uncertainties that could affect the Company’s financial and operating results are included under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission (the “SEC”) on February 26, 2016, and the Company’s more recent reports filed with the SEC. The Company can give no assurance that the conditions to the proposed transaction will be satisfied, or that it will close within the anticipated time period. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which statements were made. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Additional Information and Where to Find It
This document is being made in respect of the proposed transaction between the Company, Mars and certain subsidiaries of Mars. In connection with the proposed transaction, the Company will file relevant materials with the SEC, including a preliminary proxy statement on Schedule 14A. Following the filing of the definitive proxy statement with the SEC, the Company will mail the definitive proxy statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the proposed transaction. The Company also plans to file with the SEC other documents regarding the proposed transaction. INVESTORS AND SECURITY HOLDERS OF THE COMPANY ARE URGED TO CAREFULLY READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) IN THEIR ENTIRETY AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE PROPOSED TRANSACTION THAT THE COMPANY WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE PROPOSED TRANSACTION. When completed, a definitive proxy statement and form of proxy will be mailed to the stockholders of the Company. The definitive proxy statement, the preliminary proxy statement and other relevant materials in connection with the proposed transaction (when they become available), and any other documents filed by the Company with the SEC, may be obtained free of charge at the SEC’s website (http://www.sec.gov) or through the investor relations section of the Company’s website (http://investor.vca.com).
Participants in Solicitation
This document does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities. The Company and its directors, executive officers and certain employees may be deemed to be participants in the solicitations of proxies from the Company’s stockholders with respect to the meeting of stockholders that will be held to consider the proposed transaction. Information about the persons who may, under the SEC rules, be considered to be participants in the solicitation of stockholders of the Company in connection with the proposed transaction, is set forth in the proxy statement for the Company’s 2016 Annual Meeting of Stockholders filed with the SEC on March 4, 2016. Stockholders may obtain additional information regarding the direct and indirect interests of any such persons who may, under the SEC rules, be considered to be participants in the solicitation of stockholders of the Company in connection with the proposed transaction, including the interests of the Company’s directors and executive officers in the proposed transaction, which may be different than those of the stockholders of the Company generally, by reading the proxy statement and other relevant documents regarding the proposed transaction when they become available, which the Company will file with the SEC. Copies of these documents (when they become available) may be obtained free of charge as described in the preceding paragraph.
$ARIA to be #Acquired by #TakedaPharmaceutical
– Significantly Enhances Takeda’s Global Oncology Portfolio –
– Accretive to FY2018 Underlying Core Earnings –
– Reinforces Takeda’s Commitment to Developing Medicines for Patients Living with Cancer –
Strategic Highlights
- Highly strategic deal which transforms global oncology portfolio and pipeline by expanding into solid tumors and reinforcing existing strength in hematology
- Accretive to Takeda’s Underlying Core Earnings by FY2018 and generates immediate and long-term revenue growth
- Attractive value drivers include two very innovative precision medicines, Iclusig® (ponatinib) and brigatinib, an exciting early stage pipeline and cost synergies
- Iclusig is a globally commercialized product with continued strong sales growth potential
- Brigatinib approval in the U.S. is expected in the first half of 2017, with peak sales potential over $1 billion and the potential to be the best-in-class ALK inhibitor
- Takeda will leverage ARIAD’s research and development capabilities and platform
- Takeda retains financial flexibility with no impact on dividend policy
Takeda Pharmaceutical Company Limited (TSE:4502) (“Takeda”) and ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) (“ARIAD”) today announced that they have entered into a definitive agreement under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or an enterprise value of approximately $5.2 billion. The transaction has been approved unanimously by the boards of directors of both companies, and is expected to close by the end of February 2017, subject to required regulatory approvals and other customary closing conditions. Sarissa Capital, the holder of 6.6% of ARIAD’s common shares, as well as each of the members of ARIAD’s Board of Directors have agreed to tender their shares to Takeda pursuant to the offer.
“The acquisition of ARIAD is a unique opportunity that will enable us to positively impact the lives of more patients worldwide, advance our strategic priorities and generate attractive returns for our shareholders,” said Christophe Weber, president and chief executive officer of Takeda. “This is a very exciting time for Takeda as we will broaden our hematology portfolio and transform our global solid tumor franchise through the addition of two innovative targeted therapies. Opportunities to acquire such high-quality, complementary targeted therapies do not come often, and we are very excited about the potential for this transaction to benefit patients, our shareholders and other stakeholders.”
Paris Panayiotopoulos, president and chief executive officer of ARIAD, said, “We are very pleased to combine with Takeda, which will allow us to not only accelerate our mission to discover, develop and deliver precision therapies to patients with rare cancers, but also deliver immediate and meaningful value to our shareholders through a substantial cash premium. This exciting transaction is a testament to the hard work and dedication of ARIAD’s talented team of employees. We have tremendous respect for Takeda, and I believe our shared commitment to innovation and research-driven cultures will provide for a smooth transition.”
“This transaction is a great outcome for shareholders of ARIAD and Takeda. Both ARIAD and Takeda are passionate about helping cancer patients, and I believe the talent and resources of Takeda coupled with ARIAD’s pipeline and people will accelerate the development of cancer treatments. I would like to extend my deepest gratitude to the management team and everyone at ARIAD for their unrelenting dedication,” said Alexander J. Denner, Ph.D., Chairman of the Board of ARIAD.
Highly strategic deal which transforms global oncology portfolio and pipeline by expanding into solid tumors and reinforcing existing strength in hematology
The acquisition of ARIAD brings two innovative targeted therapies that will expand and enhance Takeda’s existing oncology portfolio. Brigatinib, an investigational drug product, has the potential to add a differentiated, global therapy in a genetically-defined subpopulation of non-small cell lung cancer (NSCLC). The addition of Iclusig will broaden Takeda’s strong hematology franchise to include chronic myeloid leukemia (CML) and a subset of acute lymphoblastic leukemia (ALL). Together, these two innovative targeted therapies will position Takeda for sustainable long-term growth in oncology.
Takeda’s track record of successful oncology product launches [ADCETRIS® (Brentuximab Vedotin), NINLAROTM (ixazomib) and VELCADE® (bortezomib)] means it has the experience and expertise required to deliver the successful launch of brigatinib and to ensure that it achieves global reach and share of voice thereafter.
Accretive to Takeda’s Underlying Core Earnings by FY2018 and generates immediate and long-term revenue growth
The transaction is a compelling opportunity for Takeda shareholders. It will provide immediate revenue, bring considerable long-term revenue potential and deliver synergy savings.
ARIAD provided calendar year 2016 revenue guidance for Iclusig of $170-180 million, and Takeda expects significant long-term revenue potential from the two lead assets.
Takeda projects the acquisition of ARIAD to be accretive to Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch.
Attractive value drivers include two very innovative medicines, Iclusig and brigatinib, an exciting early stage pipeline and cost synergies
Iclusig, a commercialized therapy with continued strong sales growth potential, delivers immediate value. Brigatinib, an investigational drug product with peak annual sales potential of over $1 billion, will generate significant long-term value for Takeda. U.S. approval is expected in the first half of 2017 with global filing thereafter. Beyond Iclusig and brigatinib, ARIAD’s commitment and expertise in targeted kinase inhibition linked to strong translational science generated further pipeline opportunities which provide additional long-term upside potential.
Takeda will leverage ARIAD’s R&D capabilities and platform, and largely absorb its R&D costs within Takeda’s existing R&D budget. G&A cost synergies will be fully captured by FY2018.
Takeda retains financial flexibility with no impact on dividend policy
The transaction will be funded by up to $4.0 billion of new debt and the remainder from existing cash. FY2017 Net Debt/EBITDA is estimated at approximately 2.6x, which is expected to remain investment grade. The transaction has no impact on Takeda’s dividend policy.
Transaction terms
The acquisition is structured as an all cash tender offer by a subsidiary of Takeda for all of the outstanding shares of ARIAD common stock, followed by a merger in which remaining shares of ARIAD would be converted into the right to receive the same $24.00 cash per share price paid in the tender offer and ARIAD will become an indirect wholly owned subsidiary of Takeda.
The transaction is subject to the tender of a majority of the outstanding shares of ARIAD common stock as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close by the end of February 2017.
Takeda Pharmaceuticals U.S.A, a wholly owned subsidiary of Takeda, has established Kiku Merger Co., Inc. to effect the transaction.
(1) | Tender offeror | Kiku Merger Co., Inc. |
(2) | Target company | ARIAD Pharmaceuticals, Inc. |
(3) | Class of shares to be acquired | Common stock |
(4) | Tender offer price | $24.00 per share |
(5) | Acquisition amount(Aggregate tender offer price) | Approximately $5.4 billion (estimate)* The amount is an estimated amount calculated by multiplying the number of the target company’s shares (fully diluted basis) by the tender offer price per share. It does not include advisory fees. |
(6) | Payment | Cash* Funded by up to $4.0 billion of new debt and the remainder from existing cash. |
(7) | Period of tender offer | From January, 2017 to February, 2017** The initial period of the tender offer will commence within 10 business days following execution of the merger agreement with ARIAD [January 8, 2017 (U.S.)], and will close 20 business days after commencement. If the situation arises whereby the conditions of the tender offer are not satisfied, the period of the tender offer will be extended, but the extension period will not exceed May 2017 (or August 2017 if antitrust clearance not received). |
(8) | Minimum number of shares to be purchased | Consummation of the tender offer will occur once the majority of shares outstanding of the company have been tendered and other customary closing conditions have been satisfied. |
(9) | Financial advisor to Takeda | Evercore Partners |
(10) | Legal counsel to Takeda | Cleary Gottlieb Steen & Hamilton LLP |
(11) | Financial advisor to ARIAD | J.P. Morgan Securities LLC, Goldman, Sachs & Co., Lazard |
(12) | Legal counsel to ARIAD | Paul, Weiss, Rifkind, Wharton & Garrison LLP |
Overview of ARIAD
(1) | Company name | ARIAD Pharmaceuticals, Inc. | ||||
(2) | Headquarters | 125 Binney Street, Cambridge, Massachusetts 02142, USA | ||||
(3) | Representative | Paris Panayiotopoulos, President and Chief Executive Officer | ||||
(4) | Business description | ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts is focused on discovering, developing and commercializing precision therapies for patients with rare cancers. ARIAD is working on new medicines to advance the treatment of rare forms of chronic and acute leukemia, lung cancer and other rare cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. | ||||
(5) | Capital | US$1,339 million (Additional paid-in capital as of December 31, 2015) | ||||
(6) | Date of establishment | April, 1991 | ||||
(7) | Major shareholdersand percentage ofshares held* | Wellington Management Group LLP | 8.8% | |||
FMR LLC | 7.8% | |||||
Vanguard Group Inc. | 6.8% | |||||
Others | ||||||
(8) | Relationships between Takeda | Capital relationship | Not applicable | |||
Personnel relationship | Not applicable | |||||
Transactional relationship | Not applicable | |||||
(9) | Operating result and financial conditions for the last three years (consolidated) | |||||
Accounting period | Fiscal year ended December 31, 2013 | Fiscal year ended December 31, 2014 | Fiscal year ended December 31, 2015 | |||
Net assets(US$ in thousands) | 185,517 | 80,801 | (103,141) | |||
Total assets(US$ in thousands) | 370,894 | 603,116 | 546,692 | |||
Net assets per share(US$) | 1.01 | 0.43 | (0.55) | |||
Revenue(US$ in thousands) | 45,561 | 105,412 | 118,804 | |||
Operating profit(US$ in thousands) | (273,566) | (160,195) | (217,276) | |||
Net loss(US$ in thousands) | (274,158) | (162,602) | (231,156) | |||
Net loss per share(US$) | (1.49) | (0.87) | (1.23) | |||
* As reported in the 13F filings. Percentage of shares is calculated by dividing the number of shareholdings (as of the end of September 2016) by the number of total shares outstanding of the target company.
Change in ownership before and after acquisition
(1) | Number of shares already acquired | 0 sharesPercentage of voting rights: 0% |
(2) | Number of shares to be acquired | 194,389,661 shares*Percentage of voting rights: 100% (planned)* Total shares outstanding |
Schedule
(1) | Board meeting resolution | January 6, 2017 |
(2) | Signing date | January 8, 2017 |
(3) | Commencement date and settlement date of the tender offer | From January, 2017 to February, 2017**The initial period of the tender offer will commence within 10 business days following execution of the merger agreement with ARIAD [January 8, 2017 (U.S.)], and will close 20 business days after commencement. If the conditions of the tender offer are not satisfied, the period of the tender offer will be extended, but the extension period will not exceed May 2017 (or August 2017 if antitrust clearance not received). |
(4) | Completion of acquisition | By the end of February, 2017 (planned)* |
* Fulfillment of the terms and conditions of the U.S. Antitrust Law and the satisfaction of certain other customary conditions are required to complete the acquisition.
Outlook
FY2016
At this stage we expect minimal impact on Underlying Revenue and Underlying Core Earnings. We do expect to incur transition and integration expenses, however, these expenses are not material to the current year result. We will incorporate the financial impact in our FY2016 consolidated earnings forecast and announce at the third quarter earnings conference in February 2017.
FY2017 and beyond
It is expected that the acquisition of ARIAD will be accretive to Takeda’s Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch. Takeda’s financial guidance, including EPS, for FY2017 will be announced when Takeda reports earnings for FY2016 in May 2017.
Conference Call Webcast Information
Takeda will host a media/investors conference call at 7:30 p.m. EST January 9, 2017 (9:30 a.m. JST January 10, 2017) to discuss the transaction.
You can listen to the conference call at the following link:
http://www.Takeda.com/investor-information/results/
A replay of the conference call will be available within 24 hours.
In light of this announcement, ARIAD will not be presenting today at the 35th Annual J.P. Morgan Healthcare Conference.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. Additional information about Takeda is available through its corporate website, www.Takeda.com.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel, Canada and Japan.
In the U.S., Iclusig is a kinase inhibitor indicated for the:
- Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
- Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.
Limitations of use:
Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.
IMPORTANT SAFETY INFORMATION
Based on the Phase 2 48 mo. follow-up analysis (N=449), except where noted
IMPORTANT U.S. SAFETY INFORMATION, INCLUDING THE BOXED WARNING
WARNING: ARTERIAL OCCLUSION, VENOUS THROMBOEMBOLISM, HEART FAILURE, and HEPATOTOXICITY
See full prescribing information for complete boxed warning.
- Arterial occlusion has occurred in at least 35% of Iclusig® (ponatinib)-treated patients including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Interrupt or stop Iclusig immediately for arterial occlusion. A benefit-risk consideration should guide a decision to restart Iclusig.
- Venous Thromboembolism has occurred in 6% of Iclusig-treated patients. Monitor for evidence of thromboembolism. Consider dose modification or discontinuation of Iclusig in patients who develop serious venous thromboembolism.
- Heart Failure, including fatalities occurred in 9% of Iclusig treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
- Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.
Warnings and Precautions
Arterial Occlusions: Arterial occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease have occurred in at least 35% of Iclusig-treated patients from the phase 1 and phase 2 trials. In the phase 2 trial, 33% (150/449) of Iclusig-treated patients experienced a cardiac vascular (21%), peripheral vascular (12%), or cerebrovascular (9%) arterial occlusive event; some patients experienced more than 1 type of event. Fatal and life-threatening events have occurred within 2 weeks of starting treatment, with doses as low as 15 mg per day. Iclusig can also cause recurrent or multi-site vascular occlusion. Patients have required revascularization procedures. The median time to onset of the first cardiac vascular, cerebrovascular, and peripheral vascular arterial occlusive events was 193, 526, and 478 days, respectively. Patients with and without cardiovascular risk factors, some age 50 years or younger, experienced these events. The most common risk factors observed with these events were hypertension, hyperlipidemia, and history of cardiac disease. Arterial occlusive events were more frequent with increasing age and in patients with a history of ischemia, hypertension, diabetes, or hyperlipidemia. In patients suspected of developing arterial occlusive events, interrupt or stop Iclusig.
Venous Thromboembolism: Venous thromboembolic events occurred in 6% (25/449) of Iclusig-treated patients with an incidence rate of 5% (13/270 CP-CML), 4% (3/85 AP-CML), 10% (6/62 BP-CML) and 9% (3/32 Ph+ ALL). Events included: deep venous thrombosis, pulmonary embolism, superficial thrombophlebitis, and retinal vein thrombosis with vision loss. Consider dose modification or discontinuation of Iclusig in patients who develop serious venous thromboembolism.
Heart Failure: Fatal or serious heart failure or left ventricular dysfunction occurred in 6% of Iclusig-treated patients (29/449). Nine percent of patients (39/449) experienced any grade of heart failure or left ventricular dysfunction. The most frequently reported heart failure events were congestive cardiac failure and decreased ejection fraction (14 patients each; 3%). Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig. Consider discontinuation if serious heart failure develops.
Hepatotoxicity: Iclusig can cause hepatotoxicity, including liver failure and death. Fulminant hepatic failure leading to death occurred in a patient within one week of starting Iclusig. Two additional fatal cases of acute liver failure also occurred. The fatal cases occurred in patients with BP-CML or Ph+ ALL. Severe hepatotoxicity occurred in all disease cohorts, with 11% (50/449) experiencing grade 3 or 4 hepatotoxicity. The most common forms of hepatotoxicity were elevations of AST or ALT (54% all grades, 8% grade 3 or 4, 5% not reversed at last follow-up), bilirubin, and alkaline phosphatase. Hepatotoxic events were observed in 29% of patients. The median time to onset of hepatotoxicity event was 3 months. Monitor liver function tests at baseline, then at least monthly or as clinically indicated. Interrupt, reduce or discontinue Iclusig as clinically indicated.
Hypertension: Treatment-emergent elevation of systolic or diastolic blood pressure (BP) occurred in 68% (306/449) of Iclusig-treated patients. Fifty-three patients (12%) experienced treatment-emergent symptomatic hypertension as a serious adverse reaction, including hypertensive crisis. Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. In patients with baseline systolic BP<140 mm Hg and baseline diastolic BP<90 mm Hg, 80% (229/285) experienced treatment-emergent hypertension; 44% (124/285) developed Stage 1 hypertension, 37% developed Stage 2 hypertension. In 132 patients with Stage 1 hypertension at baseline, 67% (88/132) developed Stage 2 hypertension. Monitor and manage blood pressure elevations during Iclusig use and treat hypertension to normalize blood pressure. Interrupt, dose reduce, or stop Iclusig if hypertension is not medically controlled. In the event of significant worsening, labile or treatment-resistant hypertension, interrupt treatment and consider evaluating for renal artery stenosis.
Pancreatitis: Pancreatitis occurred in 7% (31/449, 6% serious or grade 3/4) of Iclusig-treated patients. The incidence of treatment-emergent lipase elevation was 42% (16% grade 3 or greater). Pancreatitis resulted in discontinuation or treatment interruption in 6% of patients (26/449). The median time to onset of pancreatitis was 14 days. Twenty-three of the 31 cases of pancreatitis resolved within 2 weeks with dose interruption or reduction. Check serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated. Consider additional serum lipase monitoring in patients with a history of pancreatitis or alcohol abuse. Dose interruption or reduction may be required. In cases where lipase elevations are accompanied by abdominal symptoms, interrupt treatment with Iclusig and evaluate patients for pancreatitis. Do not consider restarting Iclusig until patients have complete resolution of symptoms and lipase levels are less than 1.5 x ULN.
Increased Toxicity in Newly Diagnosed Chronic Phase CML: In a prospective randomized clinical trial in the first-line treatment of newly diagnosed patients with chronic phase (CP) CML, single agent Iclusig 45 mg once-daily increased the risk of serious adverse reactions 2-fold compared to single agent imatinib 400 mg once-daily. The median exposure to treatment was less than 6 months. The trial was halted for safety in October 2013. Arterial and venous thrombosis and occlusions occurred at least twice as frequently in the Iclusig arm compared to the imatinib arm. Compared to imatinib-treated patients, Iclusig-treated patients exhibited a greater incidence of myelosuppression, pancreatitis, hepatotoxicity, cardiac failure, hypertension, and skin and subcutaneous tissue disorders. Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.
Neuropathy: Peripheral and cranial neuropathy have occurred in Iclusig-treated patients. Overall, 20% (90/449) of Iclusig-treated patients experienced a peripheral neuropathy event of any grade (2%, grade 3/4). The most common peripheral neuropathies reported were paresthesia (5%, 23/449), neuropathy peripheral (4%, 19/449), hypoesthesia (3%, 15/449), dysgeusia (2%, 10/449), muscular weakness (2% 10/449) and hyperesthesia (1%, 5/449). Cranial neuropathy developed in 2% (10/449) of Iclusig-treated patients (<1%, 3/449 – grade 3/4). Of the patients who developed neuropathy, 26% (23/90) developed neuropathy during the first month of treatment. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness. Consider interrupting Iclusig and evaluate if neuropathy is suspected.
Ocular Toxicity: Serious ocular toxicities leading to blindness or blurred vision have occurred in Iclusig-treated patients. Retinal toxicities including macular edema, retinal vein occlusion, and retinal hemorrhage occurred in 2% of Iclusig-treated patients. Conjunctival irritation, corneal erosion or abrasion, dry eye, conjunctivitis, conjunctival hemorrhage, hyperaemia and edema or eye pain occurred in 14% of patients. Visual blurring occurred in 6% of patients. Other ocular toxicities include cataracts, periorbital edema, blepharitis, glaucoma, eyelid edema, ocular hyperaemia, iritis, iridocyclitis, and ulcerative keratitis. Conduct comprehensive eye exams at baseline and periodically during treatment.
Hemorrhage: Serious hemorrhage events including fatalities, occurred in 6% (28/449) of patients treated with Iclusig. Hemorrhage occurred in 28% (124/449) of patients. The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML, and Ph+ ALL. Gastrointestinal hemorrhage and subdural hematoma were the most commonly reported serious bleeding events occurring in 1% (4/449) each. Most hemorrhagic events, but not all, occurred in patients with grade 4 thrombocytopenia. Interrupt Iclusig for serious or severe hemorrhage and evaluate.
Fluid Retention: Fluid retention events judged as serious occurred in 4% (18/449) of patients treated with Iclusig. One instance of brain edema was fatal. For fluid retention events occurring in >2% of the patients (treatment-emergent), serious cases included: pleural effusion (7/449, 2%), pericardial effusion (4/449, 1%), and edema peripheral (2/449, <1%).
In total, fluid retention occurred in 31% of the patients. The most common fluid retention events were peripheral edema (17%), pleural effusion (8%), pericardial effusion (4%) and peripheral swelling (3%).
Monitor patients for fluid retention and manage patients as clinically indicated. Interrupt, reduce, or discontinue Iclusig as clinically indicated.
Cardiac arrhythmias: Arrhythmias occurred in 19% (86/449) of Iclusig-treated patients, of which 7% (33/449) were grade 3 or greater. Arrhythmia of ventricular origin was reported in 3% (3/86) of all arrhythmias, with one case being grade 3 or greater. Symptomatic bradyarrhythmias that led to pacemaker implantation occurred in 1% (3/449) of Iclusig-treated patients.
Atrial fibrillation was the most common arrhythmia and occurred in 7% (31/449) of patients, approximately half of which were grade 3 or 4. Other grade 3 or 4 arrhythmia events included syncope (9 patients; 2.0%), tachycardia and bradycardia (2 patients each 0.4%), and electrocardiogram QT prolonged, atrial flutter, supraventricular tachycardia, ventricular tachycardia, atrial tachycardia, atrioventricular block complete, cardio-respiratory arrest, loss of consciousness, and sinus node dysfunction (1 patient each 0.2%). For 27 patients, the event led to hospitalization.
In patients with signs and symptoms suggestive of slow heart rate (fainting, dizziness) or rapid heart rate (chest pain, palpitations or dizziness), interrupt Iclusig and evaluate.
Myelosuppression: Myelosuppression was reported as an adverse reaction in 59% (266/449) of Iclusig-treated patients and grade 3/4 myelosuppression occurred in 50% (226/449) of patients. The incidence of these events was greater in patients with AP-CML, BP-CML, and Ph+ ALL than in patients with CP-CML.
Severe myelosuppression (Grade 3 or 4) was observed early in treatment, with a median onset time of 1 month (range <1-40 months). Obtain complete blood counts every 2 weeks for the first 3 months and then monthly or as clinically indicated, and adjust the dose as recommended.
Tumor Lysis Syndrome: Two patients (<1%, one with AP-CML and one with BP-CML) treated with Iclusig developed serious tumor lysis syndrome. Hyperuricemia occurred in 7% (31/449) of patients. Due to the potential for tumor lysis syndrome in patients with advanced disease, ensure adequate hydration and treat high uric acid levels prior to initiating therapy with Iclusig.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Postmarketing cases of reversible posterior leukoencephalopathy syndrome (RPLS—also known as Posterior Reversible Encephalopathy Syndrome (PRES)) have been reported in Iclusig-treated patients. RPLS is a neurological disorder that can present with signs and symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances. Hypertension is often present and diagnosis is made with supportive findings on magnetic resonance imaging (MRI) of the brain. If RPLS is diagnosed, interrupt Iclusig treatment and resume treatment only once the event is resolved and if the benefit of continued treatment outweighs the risk of RPLS.
Compromised Wound Healing and Gastrointestinal Perforation: Since Iclusig may compromise wound healing, interrupt Iclusig for at least 1 week prior to major surgery. Serious gastrointestinal perforation (fistula) occurred in one patient 38 days post-cholecystectomy.
Embryo-Fetal Toxicity: Based on its mechanism of action and findings from animal studies, Iclusig can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at exposures lower than human exposures at the recommended human dose. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Iclusig and for 3 weeks after the last dose.
Most Common Adverse Reactions: Overall, the most common non-hematologic adverse reactions (≥20%) were abdominal pain, rash, constipation, headache, dry skin, fatigue, hypertension, pyrexia, arthralgia, nausea, diarrhea, lipase increased, vomiting, myalgia and pain in extremity. Hematologic adverse reactions included thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia.
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning.
Iclusig is a registered trademark of ARIAD Pharmaceuticals, Inc.
Additional Information
The tender offer described in this press release has not yet commenced. This press release is provided for informational purposes only and does not constitute an offer to purchase or the solicitation of an offer to sell any securities. At the time the tender offer is commenced, Takeda and its wholly owned subsidiary, Kiku Merger Co., Inc., intend to file with the Securities and Exchange Commission (the “SEC”) a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and ARIAD intends to file with the SEC a Solicitation/Recommendation Statement on Schedule 14D 9 with respect to the tender offer. Takeda, Kiku Merger Co., Inc. and ARIAD intend to mail these documents to the ARIAD stockholders. Investors and shareholders should read those filings carefully when they become available as they will contain important information about the tender offer. Those documents may be obtained without charge at the SEC’s website at www.sec.gov. The offer to purchase and related materials may also be obtained (when available) for free by contacting the information agent for the tender offer.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking information related to Takeda, ARIAD and the proposed acquisition of ARIAD by Takeda that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements in this document include, among other things, statements about the potential benefits of the proposed acquisition, anticipated earnings accretion and growth rates, Takeda’s and ARIAD’s plans, objectives, expectations and intentions, the financial condition, results of operations and business of Takeda and ARIAD, ARIAD’s products, ARIAD’s pipeline assets, and the anticipated timing of closing of the acquisition. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions to closing the acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including uncertainties as to how many of ARIAD’s stockholders will tender their shares in the tender offer and the possibility that the acquisition does not close; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Takeda’s common stock and on Takeda’s operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; the uncertainties inherent in research and development, including the ability to sustain and increase the rate of growth in revenues for ARIAD’s products despite increasing competitive, reimbursement and economic challenges; whether and when any drug applications may be filed in any jurisdictions for any indications or any additional indications for ARIAD’s products or for ARIAD’s pipeline assets; whether and when the FDA or any other applicable regulatory authorities may approve any such applications, which will depend on its assessment of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by the FDA or other regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of ARIAD’s products and ARIAD’s pipeline assets; and competitive developments.
Many of these factors are beyond Takeda’s control. Unless otherwise required by applicable law, Takeda disclaims any intention or obligation to update forward-looking statements contained in this document as the result of new information or future events or developments.
Media and Investor Contacts
Takeda Investor Contact
Noriko Higuchi, +81 (0) 3-3278-2306
noriko.higuchi@Takeda.com
or
Takeda Media outside Japan
Shawn Goodman, 415-250-0766
shawn.goodman@Takeda.com
or
Japanese Media
Tsuyoshi Tada, +81 (0) 3-3278-2417
tsuyoshi.tada@Takeda.com
or
Kal Goldberg, Finsbury, 646-805-2005
kal.goldberg@finsbury.com
or
Chris Ryall, Finsbury, 646-805-2078
chris.ryall@finsbury.com
or
ARIAD Investor Contact
Manmeet Soni, 617-503-7298
manmeet.soni@ariad.com
or
ARIAD Media Contacts
Steve Frankel, Jed Repko, Leigh Parrish,
Joele Frank, Wilkinson Brimmer Katcher
212-355-4449
$NWMH Ends Year on High Note, Announces Final #Acquisition of 2016
HERNANDO, FL / January 9, 2017 / National Waste Management Holdings, Inc. (OTC PINK: NWMH) (“National Waste”), a growing and emerging vertically integrated solid waste management company, today announces that it has acquired Northeast Data Destruction and Recycling, LLC, located in Kingston, New York.
The transaction, which closed December 31, 2016, expands National Waste Management’s base operations in Upstate New York, where the Company is responding to customer demand for cardboard recycling and document destruction, hard drive destruction, and other data destruction.
“Acquiring Northeast Data Destruction and Recycling extends our reach to Kingston, New York, allowing us to offer roll-off services as we plan future expansion of this location. We are currently searching for a good building – either to buy or move into – that will best suit our needs and the needs of our new client base in the area,” says Louis “Tiny” Paveglio, CEO of National Waste Management. “The acquisition enables our sales team to offer the additional services in both locations, and at the same time enables us to trim overhead costs.”
National Waste Management’s acquisition strategy calls for at least one acquisition per quarter, subsequently diversifying revenue streams. The acquisition of Northeast Data Destruction and Recycling demonstrates management’s commitment to this aggressive business model.
“We are proud to announce our final acquisition of 2016, an achievement on par with our goal to become vertically integrated via strategic acquisition,” says National Waste Management CFO Dali Kranzthor. “We have more acquisitions in the pipeline and look forward to another year of building value for National Waste and its shareholders.”
About National Waste Management Holdings Inc.
National Waste Management Holdings Inc. is a growing and emerging vertically integrated solid waste management company with a concentration on C&D collection, hauling and recycling. National Waste services Florida’s west coast and upstate New York and is a distinguished leader in solid waste services. More information may be found at the Company’s website: http://www.nationalwastemgmt.com.
This release contains certain statements that are, or may be deemed to be, forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934, and are made in reliance upon the protections provided by such Acts for forward-looking statements. We have identified forward-looking statements by using words such as “expect,” “believe,” and “should.” Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company’s Form SEC filings.
Communications Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com
$ARDM to Present at 9th Annual #BiotechShowcaseConference on January 9
Aradigm Corporation (Nasdaq:ARDM) (the “Company”) today announced that President and Chief Executive Officer, Igor Gonda, Ph.D., will present an overview of the Company at the 9th Annual Biotech Showcase Conference on Monday, January 9, 2017, at 5:00 p.m. Pacific time. The event will be held at the Hilton San Francisco Union Square, San Francisco, California.
Interested parties can access a live audio webcast and slide presentation at www.aradigm.com. An archived presentation and the presentation slides will be available on the Company’s Web site for 30 days.
About Aradigm
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm is completing Phase 3 development of Pulmaquin® (an investigational proprietary formulation of ciprofloxacin for inhalation) for the treatment of non-cystic fibrosis bronchiectasis. Aradigm’s inhaled ciprofloxacin formulations including Pulmaquin are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax. In addition, Aradigm has a pipeline composed of programs to prevent diseases in tobacco smokers through smoking cessation and a diagnostic program to detect aspirations of gastrointestinal fluid into the respiratory tract. More information about Aradigm can be found at www.aradigm.com.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.
Aradigm Corporation
Nancy Pecota, 510-265-8800
Chief Financial Officer
$BIOS Announces Amendment to Credit Agreement and New #SeniorLoanFacility
DENVER, Jan. 06, 2017 — BioScrip, Inc. (NASDAQ:BIOS) (“BioScrip” or the “Company”), a leading national provider of infusion and home care management solutions, today announced that it has entered into an agreement to amend its existing Credit Agreement (the “Amendment”), dated July 31, 2013, among BioScrip, the guarantors, SunTrust Bank as administrative agent, and a syndicate of lenders. Additionally, BioScrip and the guarantors under the existing Credit Agreement announced a new $25 million senior loan facility.
The amended Credit Agreement, together with the new senior loan facility, as approved by BioScrip’s lenders, includes the following benefits:
- $25 million new senior loan facility from existing lenders, providing $19 million in incremental liquidity and a $6 million reduction in existing revolver balances
- Revised covenants, under which the Company anticipates full compliance
- Revised commitment reduction schedule, which the Company believes it can comfortably manage
About BioScrip
BioScrip, Inc. is a leading national provider of infusion and home care management solutions. BioScrip partners with physicians, hospital systems, skilled nursing facilities, healthcare payors, and pharmaceutical manufacturers to provide patients access to post-acute care services. BioScrip operates with a commitment to bring customer-focused pharmacy and related healthcare infusion therapy services into the home or alternate-site setting. By collaborating with the full spectrum of healthcare professionals and the patient, BioScrip provides cost-effective care that is driven by clinical excellence, customer service, and values that promote positive outcomes and an enhanced quality of life for those it serves.
Forward-Looking Statements – Safe Harbor
This press release includes statements that may constitute “forward-looking statements,” that involve substantial risks and uncertainties. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the fact that they do not relate strictly to historical or current facts. In some cases, forward-looking statements can be identified by words such as “may,” “should,” “could,” “anticipate,” “estimate,” “expect,” “project,” “outlook,” “aim,” “intend,” “plan,” “believe,” “predict,” “potential,” “continue” or comparable terms. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Important factors that could cause or contribute to such differences include but are not limited to risks associated with: the Company’s ability to integrate the acquisition of Home Solutions, the Company’s ability to grow its core Infusion revenues, the Company’s ability to continue to experience positive results from its financial improvement plan to reduce operating costs; the Company’s ability to comply with the covenants in its debt agreements; the success of the Company’s initiatives to mitigate the impact of the Cures Act on its business; reductions in federal, state and commercial reimbursement for the Company’s products and services; increased government regulation related to the health care and insurance industries; as well as the risks described in the Company’s periodic filings with the Securities and Exchange Commission. The Company does not undertake any duty to update these forward-looking statements after the date hereof, even though the Company’s situation may change in the future. All of the forward-looking statements herein are qualified by these cautionary statements.
For Further Information: Investor Contacts Jeffrey M. Kreger Chief Financial Officer (720) 697-5200 jeffrey.kreger@bioscrip.com David Clair ICR, Inc. (646) 277-1266 david.clair@icrinc.com
$PTX Appoints #KenPina as #GeneralCounsel and #CCO
MORRISTOWN, N.J., Jan. 06, 2017 — Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), a specialty pharmaceutical company with a focus on pain and CNS conditions, today announced the appointment of Ken Piña as Senior Vice President, General Counsel and Chief Compliance Officer. Mr. Piña will report directly to John Sedor, Chairman and Chief Executive Officer, and will serve as the Company’s senior in-house counsel, overseeing the legal and compliance area, and establishing legal and compliance strategies.
“Ken brings to Pernix extensive legal and life sciences experience with a notable record of achievement in developing and leading global legal and business initiatives for pharmaceutical companies,” said John Sedor, chairman and chief executive officer. “As our general counsel and chief compliance officer, Ken will be responsible for developing and managing our company’s legal and compliance strategies and related functional areas. He will also fill a vital role as a key member of Pernix’s Executive Leadership Team. We are delighted to welcome Ken to our company.”
Most recently, Mr. Piña was a Founder and the Managing Principal of Core Risks Ltd. (CRL), which was acquired by Jardine Lloyd Thompson. His practice focused on corporate compliance and ethics programming, enterprise risk and crisis-management program development and litigation support on behalf of a diverse client base. Prior to joining CRL, Mr. Piña served Senior Vice President, Chief Legal Officer and Secretary for Henkel Corporation, a consumer products and specialty chemical company. Before joining Henkel, he worked at Rhone-Poulenc Rorer Pharmaceuticals Inc., where he held positions of increasing responsibility, including Vice President, General Counsel and Secretary.
“Pernix has a talented team and an impressive product portfolio which represent a compelling opportunity for all of the Company’s stakeholders,” Mr. Piña said. “I look forward to supporting Pernix’s continuing efforts to enhance its operations and bring important pain management and CNS products to patients and physicians.”
Mr. Piña received his Juris Doctorate from the Dickinson School of Law, Pennsylvania State University, earned his B.S. degree from the Rutgers University College of Pharmacy. He has served as an adjunct professor of food and drug law at Temple University and as a lecturer in law at the Villanova School of Law. He is also co-editor of the industry text, An Introduction to Food and Drug Law and Regulation (FDLI).
About Pernix Therapeutics
Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its integrated Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc. To learn more about Pernix Therapeutics, visit www.pernixtx.com.
CONTACT Investor Relations Matthew P. Duffy, 212-915-0685 LifeSci Advisors, LLC matthew@lifesciadvisors.com
$NETE #UnifiedPayments Launches Payment Acceptance for #ReservHotel
Unified Payments enables payment acceptance services for leading travel distribution and booking provider
MIAMI, FL–(Jan 6, 2017) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a provider of global mobile payment technology solutions and value-added transactional services, today announces that its subsidiary Unified Payments has entered into an agreement and launched payment acceptance services for ReservHotel, a leading provider of travel distribution and booking solutions for hotels worldwide.
This contract further highlights Net Element’s capabilities as a global payment acceptance platform that facilitates cross-border transactions through a comprehensive range of services that includes on-boarding interface, extensive suite of fraud protection solutions, data analytics and reporting tools.
ReservHotel is a travel distribution and booking solutions company that offers Global Distribution System (“GDS”) connecting to over 500,000 travel agencies around the world, an award winning booking engine, channel management services to seamlessly manage rates and promotions on Hotels.com, Expedia, Booking.com, Hotelbeds.com, Travelocity, Orbitz, Trivago and Agoda, web solutions, analytics and voice reservation services. Its clients include Couples Resorts, Grand Lucayan Bahamas, Palace Resorts, Pueblo Bonito Oceanfront Resorts and Spas and Peermont Global among others. ReservHotel is a member of the Caribbean Hotel Association and certified by TripAdvisor.
“We are fortunate to be partnering with ReservHotel, a premier travel booking solution provider for independent hotels worldwide,” commented Oleg Firer, CEO of Net Element.
“We are excited about partnering with Net Element; not only can they provide a comprehensive solution for our hotel client’s payment needs, but they can adapt to work with different currencies and countries around the world which is critical for our independent hotels,” commented Luis Barberi, CEO of ReservHotel.
About ReservHotel
ReservHotel is an international marketing and service company for hotels worldwide. ReservHotel’s signature, high-tech, reservation systems have propelled its growth and success in this select markets since 1991. The influence of ReservHotel technological advancements has been widespread making it one of the largest and most innovative hotel representative companies in this industry today. Based in Miami, Florida, USA, ReservHotel’s extended presence reaches throughout the world with international offices in Mexico, Brazil, South Africa, Australia, and now Brussels, Belgium where its European Headquarters are located. Further information is available at: https://www.reservhotel.com.
About Net Element
Net Element, Inc. (NASDAQ: NETE) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US, we are growing transactional revenue with innovative services including our cloud based, restaurant point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as Russia, UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Further information is available at www.netelement.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether the relationship with ReservHotel will be beneficial to the Company, whether Net Element can secure any additional financing and if such additional financing will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
Contact:
Net Element, Inc.
media@netelement.com
+1 (786) 923-0502
$HALO Announces #Phase2 Advanced #Pancreatic #Cancer Meets Key Endpoints
-Study shows statistically significant improvement in progression-free survival (PFS) in all evaluable patients and in patients with high levels of hyaluronan (HA), a potential new biomarker- -Stage 2 of HALO 202 shows 91 percent improvement in median progression-free survival of HA-High patients in PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm- -Stage 2 Primary endpoint of reduction in Thromboembolic Events achieved- -Company to host conference call at 8:00 a.m. ET to discuss the results-
SAN DIEGO, Jan. 5, 2017 — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported topline results from the combined analysis of Stages 1 and 2 and Stage 2 alone of its HALO 202 study, a Phase 2 randomized, multi-center clinical trial of lead investigational drug PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients.
Among the findings, the overall study population showed a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving ABRAXANE and gemcitabine alone. Stage 2 of the study, which completed enrollment in February 2016, showed a 91 percent improvement in median PFS for HA-High patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm, and achieved its primary endpoint to evaluate and demonstrate a reduction in the rate of thromboembolic events in the PEGPH20 arm.
“These findings confirm our confidence in the development of PEGPH20 in this difficult to treat cancer,” said Dr. Helen Torley, president and CEO. “We are pleased by the overall consistency of both the efficacy and safety data which are supportive of our ongoing Phase 3 clinical trial, HALO 301, currently underway at more than 160 sites worldwide.”
Dr. Sunil R. Hingorani, the principal investigator leading this trial, and a pancreas cancer expert at Fred Hutchinson Cancer Research Center and professor at University of Washington School of Medicine, said: “The Study 202 data confirm for the first time in a randomized Phase 2 trial using the current standard of care that a biopsy-based biomarker for hyaluronan content can potentially identify patients who will have a meaningfully greater response when PEGPH20 is added to their treatment. The analysis suggests statistically significant and clinically important progress in this very difficult to treat cancer. The median PFS is a notable increase over the current standard of care and supports ongoing exploration in the current Phase 3 study.”
Pancreas cancer is the third-leading cause of cancer related death in the United States, and more than 65,000 people in the U.S. and top five European countries are diagnosed annually with advanced cases of the disease.
Webcast and Conference Call
Halozyme will host a webcast and conference call to discuss the results, today, Jan. 5 at 8:00 a.m. ET/5:00 a.m. PT. Presenting on the call will be Dr. Torley and Dr. Athena Countouriotis, chief medical officer. Two leading pancreas cancer experts will also participate: Dr. Hingorani, and Dr. Eileen M. O’Reilly, associate director of the David M. Rubenstein Center for Pancreatic Cancer Research, attending physician, member at Memorial Sloan Kettering Cancer Center and Professor of Medicine at Weill Cornell Medical College.
The call will be webcast live through the “Investors” section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit http://www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may also be accessed by calling 877-410-5657 (domestic callers) 334-323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 24712688.
About HALO 301 and HALO 202
HALO 301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The trial will be conducted at approximately 200 sites with two primary endpoints, progression free survival and overall survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE® (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone. Secondary endpoints also include objective response rate and overall survival. More information may be found at clinicaltrials.gov (search HALO 301 or trial identifier NCT02715804) or www.HALO301.com.
HALO 202 (Halo 109-202) is a phase 2 multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. A second primary endpoint assesses the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival.
About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies.
FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.
About Halozyme
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreas cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE™ drug delivery platform. Halozyme is headquartered in San Diego. For more information visit http://www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible activity, benefits and attributes of PEGPH20, the possible method of action of PEGPH20, its potential application to improve cancer therapies and statements concerning future actions relating to the development of PEGPH20) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company’s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission.
Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
$GNVC Signs #OptionAgreement for #GeneEditing, #CellTargeting from @WUSTLmed
Provides Exclusive Access to Gene Editing and Pulmonary Endothelial Targeting Technologies Complements and Expands Applications for the AdenoVerse™ Gene-Delivery Platform
GAITHERSBURG, Md., Jan. 5, 2017 — GenVec, Inc. (NASDAQ: GNVC), a clinical-stage gene delivery company, announced today that it has entered into an exclusive option agreement with Washington University in St. Louis to license intellectual property and technology related to gene editing and pulmonary endothelial cell targeting. If the option is exercised, the license will allow broad utilization of technology developed by David T. Curiel, M.D., Ph.D., professor of radiation oncology and Jeffrey Arbeit, M.D., professor of surgery at Washington University School of Medicine. GenVec plans to initially focus on research utilizing the technology to develop treatments for hemophilia.
“This agreement provides GenVec with the foundation to establish a proprietary and differentiated program using an individual’s pulmonary endothelium as a site for protein production,” said Douglas Swirsky, president and CEO of GenVec. “Proprietary vectors from our AdenoVerse platform are well suited for the delivery of gene editing payloads and could be useful in emerging therapeutic approaches to the long-term correction of genetic disorders such as those that cause blood factor deficiencies.”
“We are excited to have the opportunity to expand our collaboration with Washington University,” said Douglas E. Brough, Ph.D, chief scientific officer of GenVec. “Combining gene editing and pulmonary endothelial cell targeting approaches with GenVec’s AdenoVerse technology offers a unique and compelling platform to provide patients with proteins that they are deficient in to potentially address hemophilia and numerous other unmet medical needs.”
About Washington University School of Medicine in St. Louis
Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient-care institutions in the nation, currently ranked sixth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.
About GenVec
GenVec is a clinical-stage gene delivery company focused on developing a pipeline of cutting-edge therapeutics and vaccines using its proprietary AdenoVerse platform. The company is a pioneer in the design, testing and manufacture of adenoviral-based product candidates that can deliver on the promise of gene-based medicine. GenVec’s lead product candidate, CGF166, is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and balance disorders. In addition to its internal and partnered pipeline, the company is also focused on opportunities to license its proprietary technology platform, including vectors and production cell lines, for the development and manufacture of therapeutics and vaccines to the biopharmaceutical industry. Additional information about GenVec is available at www.genvec.com and in the company’s various filings with the Securities and Exchange Commission.
Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including with respect to expansion of the reach of GenVec’s technology platform, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of GenVec’s proposed product candidates (such as marketing, regulatory, patent, product liability, supply, competition and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec’s business, financial conditions and results of operations are contained in GenVec’s filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. The forward-looking statements speak only as of the date of this presentation, and GenVec assumes no duty to update forward-looking statements.
Contact:
Rena Cohen
(240) 632-5501
ir@genvec.com
$QTNT #Positive #MosaiQ #Results Performance Evaluation Study for #BloodGrouping
- Root-cause investigation completed and corrective actions implemented
- Performance evaluation study for antigen typing achieves targeted endpoints
- Completion of European field trials expected in the first half of 2017
JERSEY, Channel Islands, Jan. 05, 2017 — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported positive results from its MosaiQ™ performance evaluation study for antigen typing. The Company continues to expect European field trials for MosaiQ™, for blood grouping and the initial disease screening panel, to be completed during the first half of 2017.
“We believe the positive results from the performance evaluation study demonstrate the power and potential of MosaiQ™. Prior to commencing the study, we successfully completed the root-cause investigation previously announced and implemented all necessary corrective actions,” said Paul Cowan, Chairman and Chief Executive Officer of Quotient. “Results from the performance evaluation study demonstrate our confidence in being able to transfer existing blood grouping tests to the MosaiQ™ platform and that the MosaiQ™ instrument is robust.”
MosaiQ™, Quotient’s next-generation automation platform for blood grouping and donor disease screening, is a transformative and highly disruptive testing platform designed to address the $3.4 billion global transfusion diagnostics market. Utilizing a single instrument platform, MosaiQ™ is designed to undertake a comprehensive characterization of donor and patient blood (i.e. blood grouping) and all mandated serological and molecular disease screening tests for donor blood. Adoption of MosaiQ™ by donor- and patient-testing laboratories is expected to deliver substantial efficiencies and material cost savings, while also improving patient outcomes.
Antigen Typing Performance Evaluation Study – Results
Microarrays incorporating assays to identify ABO, Rhesus and Kell blood-group antigens were used in the performance evaluation study. Below is a summary of the results.
Blood Group |
Specificity | Total Samples |
True Positive |
False Positive |
True Negative |
False Negative |
Concordance (%) |
Sensitivity (%) |
Specificity (%) |
||||||||||||||||||||||
ABO | A | 804 | 297 | 0 | 507 | 0 | 100.0 | % | 100.0 | % | 100.0 | % | |||||||||||||||||||
B | 804 | 93 | 0 | 711 | 0 | 100.0 | % | 100.0 | % | 100.0 | % | ||||||||||||||||||||
Rhesus | D | 804 | 631 | 0 | 169 | 4 | 99.5 | % | 99.4 | % | 100.0 | % | |||||||||||||||||||
C | 804 | 502 | 0 | 302 | 0 | 100.0 | % | 100.0 | % | 100.0 | % | ||||||||||||||||||||
c | 804 | 657 | 0 | 143 | 4 | 99.5 | % | 99.4 | % | 100.0 | % | ||||||||||||||||||||
E | 804 | 264 | 0 | 540 | 0 | 100.0 | % | 100.0 | % | 100.0 | % | ||||||||||||||||||||
e | 804 | 781 | 0 | 22 | 1 | 99.9 | % | 99.9 | % | 100.0 | % | ||||||||||||||||||||
Kell | K | 804 | 78 | 0 | 726 | 0 | 100.0 | % | 100.0 | % | 100.0 | % |
Microarrays used in the study were manufactured at the Company’s Eysins, Switzerland facility (printing, wet process and final assembly), with microarrays from multiple production lots being used. Samples were acquired from donor-collection agencies and processed using MosaiQ™ instruments incorporating final hardware and the latest version of the instrument software. Results using MosaiQ™ were compared with results generated by the donor-collection laboratories providing the samples – using predicate technologies (i.e., the Beckman Coulter PK7300 or manual testing).
Performance evaluation studies for antibody screening/identification and the initial disease screening panel (to screen for CMV and Syphilis) are underway.
MosaiQ™ – Serological Disease Screening Panel
Activities with the Company’s development partner for the full serological disease screening panel have achieved their targeted milestones, prior to final internal development studies and optimization using microarrays manufactured at the Eysins, Switzerland facility and MosaiQ™ instruments.
About MosaiQ™
MosaiQ™ has been designed to offer a breadth of diagnostic tests unmatched by existing commercially available transfusion diagnostic instrument platforms, spanning blood grouping, serological disease screening for donor testing and nucleic acid testing (or molecular disease screening) for donor testing.
Once approved, MosaiQ™ will be the first fully automated solution for blood grouping, providing for the comprehensive characterization of donor and patient blood, with turnaround times significantly quicker than existing methods. Widespread adoption of MosaiQ™ is expected to improve patient outcomes through better and easier matching of donor and patient blood, given cost-effective extended antigen typing offered by MosaiQ™. Improved patient outcomes from the use of MosaiQ™ include the potential for reduced incidence of adverse events associated with transfusion, including alloimmunization where patients develop antibodies to foreign antigens introduced through transfused blood.
MosaiQ™ will also offer the opportunity for substantial cost savings and a range of operational efficiencies for donor and patient testing laboratories, including:
- elimination of the need for expensive, routine manual testing typically undertaken by highly skilled technicians;
- simplification of required consumables and testing processes;
- consolidation of multiple instrument platforms in donor testing laboratories;
- significant reduction in sample volume requirements;
- significant reduction in waste, including the number and volume of patient/donor samples required, consumables and reagent waste; and
- more streamlined processes for matching donor units to patients.
Quotient expects to develop additional applications for MosaiQ™, starting with nucleic acid testing for donor molecular disease screening, upon completion of assay development for the blood grouping and serological disease screening applications.
About Quotient Limited
Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQTM technology platform to address the $3.4 billion global transfusion diagnostics market. The Company’s operations are based in Switzerland, Scotland and the US.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include statements regarding our expectations of continued growth and the development, regulatory approval, commercialization and impact of MosaiQTM. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or denials of regulatory approvals or clearances for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expanded product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or field trial studies; adverse results in connection with any ongoing or future legal proceeding; continued or worsening adverse conditions in the general domestic and global economic markets; as well as the other risks set forth in the Company’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements.
The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.
CONTACT: Paul Cowan, Chairman & Chief Executive Officer – CEO@quotientbd.com; +1 267 756 0842
$ETRM #vBloc #Neurometabolic #Therapy Now at #MedStarHealth, #RoperStFrancis
ST. PAUL, Minn., Jan. 5, 2017 — EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Company’s vBloc® Neurometabolic Therapy has now been implanted at two additional vBloc Institutes – MedStar Health in Maryland and Roper St. Francis in South Carolina. In order to qualify as a vBloc Institute, a medical center or hospital system must have integrated the Company’s vBloc Therapy and its vBloc® Achieve support program into its practice. MedStar Health and Roper St. Francis are the twelfth and thirteenth vBloc Institute programs to have integrated vBloc Therapy and the vBloc® Achieve care delivery program into their practice to fight obesity. vBloc Institutes have previously been established at the following medical centers/hospital systems: VA North Texas Health Care System: Dallas VA Medical Center, NIX Medical (San Antonio), Hartford Hospital, Hackensack University Medical Center, South Florida Surgery and Bariatric Institute, University of Texas Medical Branch (UTMB), Smart Dimensions Weight Loss, Christiana Institute of Advanced Surgery (CHRIAS), Beltline Surgery Center, Winthrop University Hospital and Sky Ridge Medical Center.
vBloc Therapy works to control sensations of hunger using a pacemaker-like device that is implanted under the skin during a safe, minimally-invasive procedure that does not alter or remove any patient anatomy. This device can be adjusted to optimize patients’ therapy needs. Patients feel the sensation of fullness, empowering them to eat less, control their appetite, make healthier choices and lose weight without the major lifestyle implications of traditional weight loss surgeries.
vBloc Achieve is a comprehensive, personalized weight loss support program to help vBloc patients reach and maintain health goals. While vBloc Therapy addresses hunger signals and cravings, vBloc Achieve provides emotional support and helps patients make positive lifestyle changes, including health, balanced eating and regular exercise that are essential to long-term weight-loss success.
vBloc Therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a BMI of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as Type 2 diabetes, high blood pressure, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last 5 years.
About MedStar Health
MedStar Health is a not-for-profit health system dedicated to caring for people in Maryland and the Washington, D.C., region, while advancing the practice of medicine through education, innovation and research. MedStar’s 30,000 associates, 6,000 affiliated physicians, 10 hospitals, ambulatory care and urgent care centers, and the MedStar Health Research Institute are recognized regionally and nationally for excellence in medical care. As the medical education and clinical partner of Georgetown University, MedStar trains more than 1,100 medical residents annually. MedStar Health’s patient-first philosophy combines care, compassion and clinical excellence with an emphasis on customer service. For more information, visit MedStarHealth.org.
About Roper St. Francis
Roper St. Francis is Charleston, South Carolina’s only private, not-for-profit hospital system with a specific focus on community outreach. The healthcare system has three hospitals strategically located across the region: Roper Hospital on the Charleston peninsula, Bon Secours St. Francis Hospital in West Ashley and Roper St. Francis Mount Pleasant Hospital in Mount Pleasant. Roper St. Francis is among Charleston’s largest employers with more than 5,800 employees. The healthcare system has a robust, active medical staff of nearly 800 doctors representing every medical specialty and provides services in more than 125 locations in seven counties.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the vBloc® System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ vBloc® System has received U.S. Food and Drug Administration approval and CE Mark.
Information about the vBloc® System and vBloc® Neurometabolic Therapy
You should not have an implanted vBloc® System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the vBloc System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.
Talk with your doctor about the full risks and benefits of vBloc Therapy and vBloc System. For additional prescribing information, please visit www.enteromedics.com.
If you are interested in learning more about vBloc Neurometabolic Therapy, please visit www.vbloc.com or call 1-800-MY-VBLOC.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience with our vBloc® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our ability to regain and then maintain compliance with the Nasdaq continued listing requirements; our ability to commercialize our vBloc® System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our vBloc® System; physician adoption of our vBloc® System and vBloc® Neurometabolic Therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the annual report on Form 10-K filed March 28, 2016. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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