Archive for December, 2015

(AEZS) Closing of $16.65 Million Public Offering

Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the “Company”) today announced the closing of its previously announced underwritten public offering (the “Offering”) of 3.0 million common shares and warrants to acquire 2.1 million common shares with a combined purchase price of US$5.55 for one common share together with a warrant to purchase 0.7 of a common share, generating net proceeds of approximately US$15.0 million. In addition, the Company granted the underwriter a 45-day option to purchase up to an additional 330,000 common shares and/or warrants to purchase up to an additional 231,000 common shares, to cover over-allotments, if any. Prior to closing, the underwriter exercised its over-allotment option with respect to the warrants to acquire an additional 231,000 common shares, resulting in an issuance of warrants to acquire an aggregate of 2,331,000 common shares at closing.

The warrants are exercisable immediately and expire five years following issuance at an exercise price of US$7.10 per share. The warrants do not contain any price or other adjustment provision, except for customary adjustment provisions that apply in the event of certain corporate events or transactions that affect all outstanding common shares. The warrants may at any time be exercised on a “net” or “cashless” basis in accordance with a customary formula but do not contain an alternate cashless exercise feature contained in our previously issued Series B common shares purchase warrants. The warrants will not be listed on any stock exchange.

The Company intends to use the net proceeds from the Offering to continue to fund its ongoing drug development activities, for the potential addition of commercialized products to the Company’s portfolio, and for general corporate purposes, for working capital and to fund negative cash flow.

Maxim Group LLC acted as sole book-running manager, and H.C. Wainwright & Co., LLC acted as financial advisor to the Company in connection with the Offering.

In approving the Offering and listing the Common Shares issued and issuable thereunder, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual available to “Eligible Interlisted Issuers”, since the Company’s Common Shares are also listed on the NASDAQ Capital Market and had less than 25% of the overall trading volume of its listed securities occurring on all Canadian marketplaces in the twelve months immediately preceding the date on which application was made to TSX to approve the Offering.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, nor shall there be any sale of the Company’s securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.

 

Aeterna Zentaris Inc.
Philip Theodore, 843-900-3223
Senior Vice President
ptheodore@aezsinc.com

Monday, December 14th, 2015 Uncategorized Comments Off on (AEZS) Closing of $16.65 Million Public Offering

(CRMD) Enrollment and Dosing of First Patient

BEDMINSTER, N.J., Dec. 14, 2015  — CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of inflammatory and infectious diseases, today announced that the first patient has been enrolled and dosed in the LOCK-IT-100 (Catheter Lock Solution Investigational Trial) Phase 3 clinical study. The LOCK-IT-100 study will assess the efficacy and safety of Neutrolin® in preventing catheter-related bloodstream infections (CRBSIs) in subjects receiving hemodialysis therapy as treatment for end stage renal disease to support marketing approval in the United States.

“The start of our pivotal Phase 3 registration trial in the United States is a major milestone for CorMedix,” said Randy Milby, Chief Executive Officer of CorMedix. “The U.S. Food and Drug Administration (FDA) has designated Neutrolin as a Qualified Infectious Disease Product (QIDP), which provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity, and granted fast track, highlighting the large unmet need to prevent infections in the U.S. healthcare system.”

Despite all the recent improvements and initiatives in infection hygiene, there are 250,000 catheter-related blood stream infections in the United States annually with mortality rates of 20 to 25 percent. Catheter-related bloodstream infections result in extensive morbidity and mortality and prolonged hospital stays. It is estimated that there are approximately 127 million catheter days in hemodialysis in the United States per year.

Neutrolin is a novel formulation of taurolidine, citrate and heparin 1000 u/ml that provides a preventative solution, decreases the threat of infection and thrombosis to keep catheters operating safely and efficiently by optimizing catheter blood flow while minimizing infections in oncology, hemodialysis, and intensive care patients. Neutrolin has CE mark approval for use in the European Union.

“The potential to reduce or prevent complications from long-term catheter use in patients with end stage renal disease would improve quality of life for these patients with complex medical needs,” said Dr. Michael Allon, Professor of Medicine in the Division of Nephrology at the University of Alabama at Birmingham, and co-investigator of the CorMedix LOCK-IT-100 study. “Neutrolin could be a significant step forward in central venous catheter care.”

About the LOCK-IT-100 Trial
This Phase 3, prospective, multicenter, randomized, double-blind, placebo-controlled, active control study aims to demonstrate the efficacy and safety of Neutrolin in preventing CRBSIs in subjects receiving hemodialysis therapy as treatment for end stage renal disease.

The primary endpoint for the study is freedom from CRBSIs. The study will evaluate whether Neutrolin is superior to the active control heparin or normal saline control by documenting the incidence of CRBSI and the time until the occurrence of CRBSI. Key secondary endpoints are catheter patency which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction and catheter removal for any reason. An exploratory endpoint of biofilm analysis will evaluate the first 200 catheters removed.

Dr. Albert Matalon, a nephrologist and Associate Medical Director of Lower Manhattan Dialysis, CorMedix’s first dialysis site commented, “We are excited to have our four dialysis site locations participate in the inaugural first patient in CorMedix’s LOCK-IT-100 Trial. We hope we can contribute to CorMedix’s effort to improve outcomes in central venous catheter care in dialysis patients.”

About Neutrolin
Neutrolin is a novel formulation of taurolidine, citrate and heparin 1000 u/ml that provides a combination preventative solution, decreases the threat of infection and thrombosis to keep catheters operating safely and efficiently by optimizing catheter blood flow while minimizing infections in oncology, hemodialysis, and intensive care patients. Neutrolin has CE mark approval for use in the European Union.  Patients receive medication after every dialysis session which is typically three times per week to maintain catheter patency and prevent bloodstream infections.  The U.S. Food and Drug Administration (FDA) has designated Neutrolin as a Qualified Infectious Disease Product (QIDP), which provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity. Of note is the recent release of the end stage renal disease Prospective Payment System final rule from the Centers for Medicare & Medicaid Services (CMS), as it proposed an approach to pay for new drugs that suggests the agency is open to considering alternative reimbursement schemes for products that have been designated as priorities by the FDA under the GAIN Act or the Qualified Infectious Disease Product (QIDP) Act. CorMedix will be working with CMS to discuss Neutrolin specifically and hope to position it favorably in light of its potential to reduce infections and lower healthcare system costs.  The FDA also has granted Fast Tack designation to Neutrolin in recognition of the potential to address unmet medical need.

About CorMedix Inc.
CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix’s first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter-related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval. For more information, visit www.cormedix.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, should be considered forward-looking. Risks applicable to CorMedix are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Monday, December 14th, 2015 Uncategorized Comments Off on (CRMD) Enrollment and Dosing of First Patient

(NRX) FDA IND, Clinical Study of IV Pyridorin in Acute Kidney Injury

NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug (IND) application for clinical studies with intravenous Pyridorin® for the treatment of acute kidney injury.

Acute kidney injury (AKI) is a serious medical condition characterized by an abrupt loss of kidney function. AKI is estimated to affect up to 18 percent of hospital inpatients and is responsible for approximately 2 million deaths annually worldwide.1, 2 In Company sponsored preclinical studies, I.V. Pyridorin ameliorated renal oxidative stress and injury, enhanced functional recovery and reduced post-injury fibrosis. Additionally, a recently completed preclinical toxicity study of intravenous Pyridorin did not show signs of toxicity or intolerance to the drug.

“The clearance of our IND application for I.V. Pyridorin represents a significant milestone for our AKI program,” said Dr. Jaikrishna Patel, Chief Medical Officer. “We look forward to further investigating intravenous Pyridorin, which we believe has the potential to be an important treatment option for patients suffering from hospital-acquired AKI.”

About Acute Kidney Injury

Acute kidney injury (AKI) is a serious medical condition and significant cause of morbidity, extended hospitalizations and increased medical costs. AKI is characterized by an abrupt loss of kidney function that usually develops within a few hours to a few days, and occurs when the kidneys suddenly become unable to filter water and waste products from the body. AKI is most common in patients who have been hospitalized for other critical conditions or in patients who require surgery. Major causes of hospital-acquired AKI include decreased renal perfusion during surgery, contrast nephropathy and cancer therapy with nephrotoxic drugs such as cisplatin.

About Pyridorin®

Pyridorin is an investigational compound with a distinct chemical structure that inhibits the formation of advanced glycation end-products (AGEs). AGEs have been implicated in the development of diabetic nephropathy. In people with diabetes, elevated glucose reacts with proteins to form complexes that are then deposited within the kidney leading to damage that interferes with normal kidney function. AGEs also lead to the generation of highly reactive molecules such as carbonyls and reactive oxygen species that can damage both the outside of the cell and important structures within the cell.

About NephroGenex, Inc.

NephroGenex (Nasdaq: NRX) is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases. Since our inception, we have collaborated with the leading scientific experts to build a portfolio of intellectual property and novel drug candidates. Our clinical program has been designed and implemented in collaboration with world leading clinical investigators in kidney disease. Our product pipeline includes an oral formulation of Pyridorin, which is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy, as well as an intravenous formulation of Pyridorin to treat acute kidney injury.

Cautionary Note on Forward-Looking Statements

This press release contains certain statements that are, or may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning and include, but are not limited to, statements regarding the outlook for our future business and financial performance. Forward-looking statements are based on our current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may differ materially from those in the forward-looking statements due to global political, economic, business, competitive, market, regulatory and other factors and risks, including the items identified in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2015, and the “Risk Factors” sections of our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2015, June 30, 2015 and September 30, 2015 filed with the SEC on May 13, 2015, August 12, 2015 and November 12, 2015, respectively, as well as in other filings that we may make with the SEC in the future. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements.

1. Lewington AJP, Certa J, Mehta RL Raising Awareness of Acute Kidney Injury: A Global Perspective of a Silent Killer. Kidney Int. 2013;84(3):457-467

2. Chawla L, Kimmel P. Acute Kidney Injury and Chronic Kidney Disease. Kidney Int. 2012;82(5):516-524.

 

Investors
The Trout Group
Michael Levitan, 646-378-2920
mlevitan@troutgroup.com
or
Media
BMC Communications
Amy Bonanno, 646-513-3117
abonanno@bmccommunications.com

Monday, December 14th, 2015 Uncategorized Comments Off on (NRX) FDA IND, Clinical Study of IV Pyridorin in Acute Kidney Injury

(ISCO) Phase I/IIa Clinical Trial of ISC-hpNSC in Parkinson’s Authorized

Regulatory Submission (CTX) Cleared for Phase I Dose Escalation Trial in Patients With Moderate to Severe Parkinson’s Disease

CARLSBAD, CA–(December 14, 2015) – International Stem Cell Corporation (OTCQB: ISCO), a leader in using pluripotent stem cells in regenerative medicine, announced today that the Therapeutics Goods Administration (TGA) of Australia cleared a regulatory submission of ISCO’s wholly owned subsidiary, Cyto Therapeutics, to initiate a Phase I/IIa clinical trial, dose escalation trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) in patients with moderate to severe Parkinson’s disease (PD). Currently, there is no cure for PD, which is the second most common neurodegenerative disease and affects over 7 million people worldwide.

“We are very pleased to start the first human study of ISC-hpNSC’s for the treatment of this debilitating disease. There is a large unmet medical need for new treatments that may halt or reverse the progression of Parkinson’s disease and we believe our human neural stem cells may fill this need for the millions of people with this disease” commented Andrey Semechkin, PhD, ISCO’s chief executive officer. “We look forward to reporting on the progress of the clinical trial over the coming months.”

The Company last year announced positive results from its preclinical studies for its ISC-hpNSC therapeutic candidate. In those preclinical studies, the cells demonstrated an improvement in Parkinson’s disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC. The studies further noted that the ISC-hpNSCs provided neurotrophic support and cell replacement to dying dopaminergic neurons.

About the clinical study

The Phase I/IIa clinical study is a dose escalation safety and preliminary efficacy study of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC) intracranialy transplanted into patients with moderate to severe Parkinson’s disease. The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30,000,000 to 70,000,000 neural cells. A total of 12 participants with moderate to severe Parkinson’s disease will be treated. Following transplantation, the patients will be monitored for 12 months at specified intervals, to evaluate the safety and biologic activity of ISC-hpNSC. PET scan will be performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC will be evaluated using various neurological assessments.

The study will be performed at Royal Melbourne Hospital in Melbourne, Australia.

“We are the first company in the world to conduct clinical trials of human pluripotent stem cells based product for the treatment of Parkinson’s disease. We believe the outcome of the study will produce findings in-line with our preclinical studies, where we demonstrated not only safety of our proprietary neural stem cells, but also their functional efficacy. The cells were able to successfully integrate into the brain and provide a significant increase of dopamine levels in the nigrostriatal system” commented Russell Kern, PhD, ISCO’s Executive Vice President and chief scientific officer.

About Parkinson’s disease

Parkinson’s disease is a degenerative disorder of the central nervous system mainly affecting the motor system. The motor symptoms of Parkinson’s disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain. Early in the course of the disease, the most obvious symptoms are movement-related; these symptoms include shaking, rigidity, slowness of movement and difficulty with walking and gait. Later, thinking and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease, and depression is the most common psychiatric symptom. Parkinson’s disease is more common in older people, with most cases occurring after the age of 50.

Currently, medications typically used in the treatment of Parkinson’s, L-DOPA and dopamine agonists, improve the early symptoms of the disease. As the disease progresses and dopaminergic neurons continue to be lost, the drugs eventually become ineffective while at the same time frequently producing a complication marked by involuntary writhing movements. In 2013 PD resulted in about 103,000 deaths globally, up from 44,000 deaths in 1990.

About ISC-hpNSC

International Stem Cell Corporation’s proprietary ISC-hpNSC consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. ISC-hpNSC is a suspension of clinical grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are clear of any microbial and viral contaminants. Preclinical studies in rodents and non-human primates have shown improvement in Parkinson’s disease symptoms and increase in brain dopamine levels following the intracranial administration of ISC-hpNSC. ISC-hpNSC provides neurotrophic support and cell replacement to the dying dopaminergic neurons of the recipient PD brain. Additionally, ISC-hpNSC are safe, well tolerated and do not cause adverse events such as dyskinesia, systemic toxicity or tumors in preclinical models. International Stem Cell Corporation believes that ISC-hpNSC may have broad therapeutic applications for many neurological diseases affecting the brain, the spinal cord and the eye.

About International Stem Cell Corporation

International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Safe harbor statement

Statements pertaining to anticipated developments, expected results of clinical studies, potential applications of ISC-hpNSCs to other diseases, progress of research and development initiatives, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Contact

International Stem Cell Corporation
Russell A. Kern, PhD
Phone: 760-940-6383
Email: ir@intlstemcell.com

Media
Christopher R. Hippolyte
Phone: +1-646-942-5634
Email: chris.hippolyte@russopartnersllc.com

Tony Russo, Ph.D.
Phone: (212) 845-4251
Email: tony.russo@russopartnersllc.com

Monday, December 14th, 2015 Uncategorized Comments Off on (ISCO) Phase I/IIa Clinical Trial of ISC-hpNSC in Parkinson’s Authorized

(CETX) Sees Strong Opportunities from Progress in Paris Climate Talks

FARMINGDALE, N.Y., Dec. 11, 2015  — Cemtrex (NASDAQ: CETX), a diversified industrial and manufacturing leader, announced today that it sees new opportunities based on the progress of ongoing Climate Change discussions taking place in Paris, France this week. World leaders of over 190 countries  both developing and leading nations have gathered at the United Nations Conference on Climate Change to address air pollution and curbing greenhouse gases. The Company’s Continuous Emission Monitoring Systems (CEMS), specifically the IS 2500 Gas Analyzer, are designed to monitor greenhouse gases and other air pollutants that are emitted from conventional coal, oil, and natural gas power sources.

The Conference objective is to achieve a legally binding and universal agreement on climate, from all the nations of the world, to be signed in 2015 and limit the global warming below 2 degrees Celsius by 2100 as compared to before the industrial era.  A little more than half of global greenhouse gas emissions come from the energy and industrial production sectors.

According to Markets & Markets report the Emission Monitoring Systems Market is estimated to reach USD 2.81 Billion by 2020. Continuous Emission monitoring Systems (CEMS) is expected to account for highest market size during this forecast period.  According to the report, the rise in stringent rules and regulations regarding pollution monitoring across various industries and the increasing demand for process control improvements is another factor contributing to the growth of the CEMS market.

Cemtrex’s  IS 2500 is a unique technology that has been designed to measure greenhouse gases in a cost effective way, making it ideal for developing countries trying to adopt greenhouse gas monitoring into their power and industrial plants. Continuous measurements would be required for facilities to disclose their greenhouse gas output and with web enabled software inbuilt into the IS 2500, it can provide online real time information for greenhouse gas emissions from the smoke stack 24/7/365.

Cemtrex’s CEO, Saagar Govil, commented, “We see the cost effective monitoring of greenhouse gases as an enormous challenge for many industrial companies in developing countries. We have designed the IS 2500 with this challenge in mind and believe that with this new product we can garner a sizeable market share that will open up due to the binding commitments put forth by the Paris Climate Agreement.”

About Cemtrex

Cemtrex, Inc. (NASDAQ:CETX) is a world leading diversified industrial and manufacturing company that provides a wide array of solutions to meet today’s technology challenges. Cemtrex provides manufacturing services of advanced custom engineered electronics, monitoring instruments for industrial processes and environmental compliance, and systems for controlling particulates, hazardous gases, emissions of Greenhouse gases, and other regulated pollutants used in emissions trading globally.
www.cemtrex.com

Safe Harbor Statement
This press release contains forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date.

For further information, please contact:

Investor Relations
Cemtrex, Inc.
Phone: 631-756-9116
Email

Friday, December 11th, 2015 Uncategorized Comments Off on (CETX) Sees Strong Opportunities from Progress in Paris Climate Talks

(TW) Willis and Towers Watson Shareholders Approve Merger

Shareholders Vote to Create Leading Global Advisory, Broking and Solutions Firm

Transaction Expected to Close Very Early in the New Year

Willis Group Holdings (NYSE:WSH) and Towers Watson (Nasdaq:TW) have announced the preliminary results of their respective special meetings of shareholders that were held earlier today. Shareholders of each company approved the proposals necessary to complete the merger of equals transaction. The companies expect that the transaction will close very early in the New Year, subject to customary closing conditions, including the receipt of certain regulatory approvals.

“We are pleased with the outcome of today’s vote and thank all of our shareholders for their support,” said John Haley, Chairman and Chief Executive Officer of Towers Watson. “We are confident that combining Towers Watson and Willis will accelerate both companies’ long-term strategies and create substantial incremental value for shareholders. We look forward to working with Willis to successfully complete the transaction and realize the full benefits of the merger for all of our stakeholders.”

Dominic Casserley, Chief Executive Officer of Willis, added, “With the support of our shareholders, we are now focused on completing the transaction, successfully integrating the businesses and realizing the combination’s full value creation potential. These efforts are well underway, and we expect that they will create substantial incremental shareholder value through revenue, cash flow, and EBITDA growth superior to what either company could achieve independently.”

At Willis’s Extraordinary General Meeting of Shareholders, shareholders approved a proposal that Willis issue new shares to Towers Watson shareholders as required to complete the merger. Shareholders also approved proposals to change the name of the combined company to Willis Towers Watson upon completion of the merger and to execute a reverse stock split in which every 2.6490 Willis shares would be converted to one share, allowing Towers Watson shareholders to receive one post-split Willis share for each Towers Watson share.

At Towers Watson’s Special Meeting of Stockholders, shareholders voted in favor of a proposal to approve the merger agreement with Willis, the only Towers Watson shareholder approval required for Towers Watson to complete the merger. In other business at the meeting, Towers Watson shareholders approved, on a non-binding, advisory basis, specified compensation arrangements between Towers Watson and its named executive officers relating to the transactions contemplated by the Merger Agreement.

Additional information is available at www.willisandtowerswatson.mergerannouncement.com.

About Willis Group

Willis Group Holdings plc is a leading global risk advisory, re/insurance broker and human capital and benefits firm. With roots dating to 1828, Willis operates today on every continent with more than 18,000 employees in over 400 offices. Willis offers its clients superior expertise, teamwork, innovation and market-leading products and professional services in risk management and transfer. Our experts rank among the world’s leading authorities on analytics, modelling and mitigation strategies at the intersection of global commerce and extreme events. Find more information at our website, www.willis.com, our leadership journal, Resilience, or our up-to-the-minute blog on breaking news, WillisWire. Across geographies, industries and specialisms, Willis provides its local and multinational clients with resilience for a risky world.

About Towers Watson

Towers Watson is a leading global professional services company that helps organizations improve performance through effective people, risk and financial management. With 16,000 associates around the world, the company offers consulting, technology and solutions in the areas of benefits, talent management, rewards, and risk and capital management. Learn more at towerswatson.com.

Responsibility Statement

The directors of Willis accept responsibility for the information contained in this document other than that relating to Towers Watson, the Towers Watson Group and the directors of Towers Watson and members of their immediate families, related trusts and persons connected with them. To the best of the knowledge and belief of the directors of Willis (who have taken all reasonable care to ensure that such is the case) the information contained in this document for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information. The directors of Towers Watson accept responsibility for the information contained in this document relating to Towers Watson, the Towers Watson Group and the directors of Towers Watson and members of their immediate families, related trusts and persons connected with them. To the best of the knowledge and belief of the directors of Towers Watson (who have taken all reasonable care to ensure that such is the case) the information contained in this document for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

Forward-Looking Statements

This document contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements and other forward-looking statements in this document by words such as “may”, “will”, “would”, “expect”, “anticipate”, “believe”, “estimate”, “plan”, “intend”, “continue”, or similar words, expressions or the negative of such terms or other comparable terminology. These statements include, but are not limited to, the expected closing of the merger; the benefits of the business combination transaction involving Towers Watson and Willis Group, including the combined company’s future financial and operating results, plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Towers Watson’s and Willis Group’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the ability to obtain governmental approvals of the transaction on the proposed terms and schedule; the failure of the transaction to close for any reason; the risk that the businesses will not be integrated successfully; the risk that anticipated cost savings and any other synergies from the transaction may not be fully realized or may take longer to realize than expected; the potential impact of the announcement or consummation of the proposed transaction on relationships, including with employees, suppliers, customers and competitors; changes in general economic, business and political conditions, including changes in the financial markets; significant competition; compliance with extensive government regulation; the combined company’s ability to make acquisitions and its ability to integrate or manage such acquired businesses. Additional risks and factors are identified under “Risk Factors” in Towers Watson’s Annual Report on Form 10-K filed on August 14, 2015, which is on file with the Commission, and under “Risk Factors” in the joint proxy statement/prospectus.

You should not rely upon forward-looking statements as predictions of future events because these statements are based on assumptions that may not come true and are speculative by their nature. Neither Towers Watson or Willis Group undertakes an obligation to update any of the forward-looking information included in this document, whether as a result of new information, future events, changed expectations or otherwise.

 

For Willis:
Investors
Matt Rohrmann, +1 212-915-8180
matt.rohrmann@willis.com
or
Media Contacts
Miles Russell, +44 (0) 7903 262118 / +44 (0) 20 3124 7446
or
Stephen Cohen, + 1 212-886-9332
stephen.cohen@teneostrategy.com
or
For Towers Watson:
Investors
Aida Sukys, +1 703-258-8033
aida.sukys@towerswatson.com
or
Media
Sard Verbinnen & Co
Michael Henson / Conrad Harrington
+44 (0) 20 3178 8914
or
Bryan Locke / Jenny Gore
+1 312-895-4700

Friday, December 11th, 2015 Uncategorized Comments Off on (TW) Willis and Towers Watson Shareholders Approve Merger

(IMOS) Tsinghua Unigroup Agrees To Purchase 25.0% of Chipmos Taiwan for NT$12.0 Billion

HSINCHU, Taiwan, Dec. 11, 2015 — ChipMOS TECHNOLOGIES (Bermuda) LTD. (“ChipMOS” or the “Company”) (Nasdaq: IMOS), an industry leading provider of outsourced semiconductor assembly and test services (“OSAT”), today announced that the Board of Directors of its 58.0% owned subsidiary ChipMOS TECHNOLOGIES INC. (“ChipMOS Taiwan”, Taiwan Stock Exchange Stock Ticker 8150) has authorized and signed a share purchase agreement to sell 299,252,000 common shares of ChipMOS Taiwan to Tsinghua Unigroup Ltd. (“Tsinghua Unigroup”) through private placement (“Private Placement Shares”) at a price of NT$40.0 per common share.  ChipMOS Taiwan today also executed a Strategic Alliance Agreement with Tsinghua Unigroup designed to strengthen the long-term cooperation relationship between the two companies.

The Board of Directors of parent company ChipMOS has authorized the Special Committee, established by the Board on July 14, 2015, to evaluate and provide a recommendation to the Board regarding approval of the proposed Private Placement by the Company as a ChipMOS Taiwan shareholder in connection with the Special Committee’s review and evaluation of a merger of the Company into ChipMOS Taiwan.  The proposed Private Placement is also subject to ChipMOS Taiwan shareholder approval and routine regulatory approvals in Taiwan.  The proposed transaction would be valued at approximately NT$12.0 billion (approximately US$368.3 million).  After the issuance of the Private Placement Shares, Tsinghua Unigroup would own approximately 25.0% of ChipMOS Taiwan.  Parent company ChipMOS’s ownership in its subsidiary ChipMOS Taiwan would be 43.7% post-placement compared to the current 58.0%.  ChipMOS Taiwan expects it would use proceeds from the proposed Private Placement for capacity expansion and technology development in mainland China and Taiwan, potential acquisitions and general corporate purposes.

Share Subscription Agreement:

Pursuant to the Share Subscription Agreement executed by and between ChipMOS Taiwan and strategic investor Tsinghua Unigroup, Tsinghua Unigroup will subscribe for the entirety of the Private Placement Shares through its controlled entity with price of NT$40.0 per share and will appoint one representative to be elected as the Director of ChipMOS Taiwan.  Tsinghua Unigroup undertakes that it will abide by the laws and rules of Taiwan in connection with investments made by Mainland China investors, including: (1) it will not to have the control over ChipMOS Taiwan; (2) it will not to serve as the managerial officer of ChipMOS Taiwan or appoint managerial officers of ChipMOS Taiwan; (3) the board seats held by Tsinghua Unigroup in ChipMOS Taiwan will not out-number the seats held by all other shareholders; (4) it will not to solicit proxy for ChipMOS Taiwan’s shareholders meeting; and (5) it will undertake other matters required by the competent authorities.

Strategic Alliance Agreement:

ChipMOS Taiwan and Tsinghua Unigroup today also executed a Strategic Alliance Agreement designed to strengthen the long-term cooperation relationship between the two companies.  Tsinghua Unigroup will assist ChipMOS Taiwan in expanding and strengthening the relationship between ChipMOS Taiwan and companies relating to the assembly and testing services of LCD drivers and wafer bumping services in Mainland China, and will introduce other potential suppliers, customers and business partners in Mainland China to ChipMOS Taiwan.

About ChipMOS TECHNOLOGIES (Bermuda) LTD.:

ChipMOS TECHNOLOGIES (Bermuda) LTD. (“ChipMOS” or the “Company”) (NASDAQ: IMOS) (http://www.chipmos.com) is an industry leading provider of semiconductor assembly and test services. With advanced facilities in Hsinchu Science Park, Hsinchu Industrial Park and Southern Taiwan Science Park in Taiwan and Qingpu Industrial Zone in Shanghai, ChipMOS and its subsidiaries provide assembly and test services to a broad range of customers, including leading fabless semiconductor companies, integrated device manufacturers and independent semiconductor foundries. The Company’s majority-owned subsidiary, ChipMOS Taiwan, is listed on the Taiwan Stock Exchange under Stock Ticker 8150.

Forward-Looking Statements

Certain statements contained in this announcement may be viewed as “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual performance, financial condition or results of operations of the Company to be materially different from any future performance, financial condition or results of operations implied by such forward-looking statements. Further information regarding these risks, uncertainties and other factors is included in the Company’s most recent Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) and in the Company’s other filings with the SEC.

Contacts:

In TaiwanDr. S.K. Chen

ChipMOS TECHNOLOGIES (Bermuda) LTD.

+886-6-507-7712

s.k._chen@chipmos.com

In the U.S.David Pasquale

Global IR Partners

+1-914-337-8801

dpasquale@globalirpartners.com

Friday, December 11th, 2015 Uncategorized Comments Off on (IMOS) Tsinghua Unigroup Agrees To Purchase 25.0% of Chipmos Taiwan for NT$12.0 Billion

(RUN) Announces Opening of New Corporate Office in Denver

Leading Residential Solar Company Plans to Create Hundreds of New Jobs in Colorado

SAN FRANCISCO, Dec. 11, 2015  — Sunrun (Nasdaq:RUN) the largest dedicated residential solar company in the United States, today announced Denver, Colo. as the location for its newest corporate office. The company expects to open an office in downtown Denver before the end of 2015 and plans to hire up to 800 workers over the next few years. The expansion underscores Sunrun’s growth over the past year, most recently announcing it has surpassed 100,000 customers.

Sunrun’s new office expands the company’s geographic footprint nationwide to support consumer demand for home solar into 2016. In Colorado, Sunrun has saved local homeowners more than $4.3 million on their electric bills since 2007. The company will also help advance Colorado’s cleantech industry by offering employment opportunities in operations, project planning and design engineering.

“We already know that Colorado homeowners love solar and that Colorado has a highly skilled workforce. Our fast-growing industry also has support from Colorado’s elected leaders through strong in-state and federal solar policies like the solar Investment Tax Credit (ITC),” said Lynn Jurich, chief executive officer of Sunrun. “That’s why we’re thrilled to grow Sunrun’s presence in the state with technology-oriented functions that will power solar’s growth nationwide.”

Sunrun largely attributes its expansion into Colorado to the leadership of Governor Hickenlooper and policymakers. As a strong supporter of the solar industry, the state of Colorado invested more than $212 million in installations in 2014, according to the Solar Energy Industries Association (SEIA). The state’s solar industry also employs more than 4,200 people, according to The Solar Foundation.

Gov. Hickenlooper and Denver Mayor Michael Hancock expressed their support for Sunrun’s continued growth. Today they will officially welcome Sunrun to Denver during a press conference at the Capitol building beginning at 9:00 a.m. MST.

“Colorado is thrilled to be home to Sunrun’s new corporate office. Colorado’s forward-thinking energy policies and talented workforce will support the company’s creation of new jobs and savings for homeowners while diversifying the state’s energy economy,” said Governor Hickenlooper. “Sunrun has proven its business and advantages for homeowners. We look forward to supporting Sunrun’s future growth.”

“Renewable energy and finding innovative ways to power our homes is one of the next great economic opportunities, and we’re proud that Sunrun has chosen Denver for their next-stage growth and success,” said Mayor Michael Hancock. “With Sunrun joining a roster of leading industry firms here in the city, we can build on our momentum as a leading center for progress in this important and growing sector.”

As the first company to introduce solar as a service to American homeowners, Sunrun has reinvented the way people buy electricity. Sunrun gives homeowners access to the smartest energy source – sunlight – and takes care of everything so families can focus on more important things, like putting savings back in their pockets each month.

To apply for open Sunrun positions in Denver and learn more about what it is like to work at Sunrun, visit Sunrun’s Careers page.

About Sunrun

Sunrun (NASDAQ:RUN) is the largest dedicated residential solar company in the United States with a mission to create a planet run by the sun. Since establishing the solar as a service model in 2007, Sunrun continues to lead the industry in providing clean energy to homeowners with little to no upfront cost and at a savings to traditional electricity. The company designs, installs, finances, insures, monitors and maintains the solar panels on a homeowner’s roof, while families receive predictable pricing for 20 years or more. For more information please visit: www.sunrun.com.

Forward Looking Statements

This press release contains forward-looking statements including, but not limited to, statements regarding expansion, future hiring, future potential for a specific market, growth of our company and demand for our products and services. Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward looking statements. You should read the section entitled “Risk Factors” in Sunrun’s quarterly report on Form 10-Q, which has been filed with the Securities and Exchange Commission and identifies certain of these and additional risks and uncertainties. We do not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

U.S. Equal Employment Opportunity/Affirmative Action Information: Individuals seeking employment are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, or sexual orientation. 

Sunrun Media Contact                                     
Becky Loya
becky.loya@ketchum.com
415-984-6278
Friday, December 11th, 2015 Uncategorized Comments Off on (RUN) Announces Opening of New Corporate Office in Denver

(BPMX) Study Shows Safety of BioPharmX Topical Formulation

Research suggests BPX-01 topical minocycline could be more effective in treatment of acne than other topical treatments

MENLO PARK, Calif., Dec. 11, 2015  — BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company, announced today that research being presented at ASCB 2015 in San Diego shows its unique formulation of minocycline known as BPX-01 may offer a breakthrough in acne treatment because it can safely deliver the antibiotic to the layer of skin where the condition develops.

Study findings will be presented Monday afternoon at the annual gathering of the American Society of Cell Biology.

Session:  Defining Therapeutic Targets and New Therapeutics 2
Time: 1:30pm to 3:00pm
Location:  ASCB Learning Center, Exhibit Halls D-H

BPX-01 is the first and only stable hydrophilic (non-oil-based) topical gel with fully solubilized minocycline, the antibacterial and anti-inflammatory medicine most commonly prescribed to treat acne because it has a lower resistance rate than other antibiotics.

Topical acne medications available today penetrate the top layer of skin with less effective antibiotics. However, minocycline is generally prescribed as an oral medication due to the lack of availability of effective topical medications. High doses of oral minocycline are associated with various side effects that can discourage compliance.

“Our preliminary findings in animals and in vitro human skin indicate that minocycline delivered by BPX-01 is safely absorbed into the skin, reaching the epidermis and the pilosebaceous unit where acne develops,” said Kin F. Chan, Ph.D., executive vice president of research and development at BioPharmX Corporation. “The studies clearly indicate that all doses of BPX-01 were found to be safe and nontoxic for topical use, virtually eliminating risk of undesirable side effects.”

The BioPharmX research also found that the hydrophilic BPX-01 formulation distributes evenly, is not sticky and does not occlude or irritate the skin, an advantage in the treatment of acne.

The American Academy of Dermatology calls acne the “most common skin condition in the United States,” affecting 40 million to 50 million Americans at any given moment. The disease can cause permanent scarring, low self-esteem, depression and anxiety.

About BioPharmX™ Corporation
BioPharmX Corporation (NYSE MKT: BPMX) is a Silicon Valley-based specialty pharmaceutical company, which seeks to provide products through proprietary platform technologies for prescription, over-the-counter (“OTC”), and supplement applications in the health and wellness markets, including dermatology and women’s health. To learn more about BioPharmX, visit www.BioPharmX.com.

Forward-Looking Statements
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those section. This press release contains forward-looking statements about the company’s expectations, plans, intentions, and strategies, including, but not limited to, statements regarding, including with respect to: the success of the commercialization of VI2OLET iodine, the effectiveness of BPX01, the timing with respect to filing an IND and clinical trials for BPX-01, the release of key data for BPX01, the release of key data and the successful completion of multi-site IRB studies for BPX03 and the successful completion of the private placement with Korea Investment Partners Overseas Expansion Platform Fund. These forward-looking statements may be identified by words such as “plan”, “expect,” “anticipate,” “believe,” or similar expressions that are intended to identify such forward-looking statements.   These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The risks and uncertainties include those described in the company’s filings with the Securities and Exchange Commission.  Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements.  The forward-looking statements included in this news release are made only as of the date hereof and the company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

BioPharmX and Violet are registered trademarks of BioPharmX, Inc.

Friday, December 11th, 2015 Uncategorized Comments Off on (BPMX) Study Shows Safety of BioPharmX Topical Formulation

(OGES) To Be Highlighted On FOX Business New To The Street Broadcast

NEW YORK, NY–(December 11, 2015) – “New To The Street” will be broadcasting its latest show, nationwide on FOX Business, Sunday, December 13, 2015 at 4:30 P.M., potentially reaching 83.1M households.

This show will feature a teaser about PetProducts.com which was recently launched in beta testing. In addition to the thousands of stores and products on the site, an additional 10000+ pet related companies have just been added. New pet products, stores and services are being added daily.

The guest companies highlighted on this show are Daniel de Liege, CEO of Alliance BioEnergy Plus, Inc., (OTCQB: ALLM); Tony Chiodo, CEO of Soul and Vibe Interactive, Inc., (OTCQB: SOUL), updates from George Jarjour, COO of Seen on Screen TV, Inc., (OTCQB: SONT), and the press conference featuring Florida’s Governor, Rick Scott at the headquarters of Oakridge Global Energy Solution, Inc., (OTCQB: OGES).

“‘New To The Street’ is expanding its audience reach and airing on FOX Business, a perfect place to start our media expansion. Our show features a diverse mix of companies and we welcome the diverse audience that FOX Business brings to us,” says Vince Caruso, President, “New To The Street.”

“New To The Street” just wrapped up its last series taping on December 3, 2015, at their state of the art studio in New York City, New York. This show will feature a variety of clients, both new and old including; Alliance Bioenergy Plus, Inc, (OTCQB: ALLM), Goldland Holdings Co. (New), (OTC PINK: GHDC), Seen on Screen TV, Inc. (OTCQB: SONT), Accurexa, Inc., (OTCQB: ACXA), and Night Food Holdings, Inc., (OTC PINK: NGTF).

“New To The Street” is looking forward to its continued monthly series and the next taping is set for January 27, 2016, featuring the following:

Indoor Harvest Corp., (OTCQB: INQD)

Gemini Group Global Corp., (OTC PINK: GMNI)

Soul & Vibe Interactive, Inc., (OTCQB: SOUL)

bBooth, Inc., (OTCQB: BBTH)

Oakridge Global Energy Solutions, Inc., (OTCQB: OGES)

Green Polka Dot Box, Inc., (OTC PINK: GPDB)

“New To The Street” will be implementing ALL these program interviews with Twitter, (NYSE: TWTR), in its video marketing beta program.

About “New To The Street”
“New To The Street” paves the way to the latest financial issues, offering a blend of business and financial services news reporting and in-depth interviews relating to new products, economic analysis and public company profiles. New to the Street is produced by FMW Media Works Corp. a leading provider of business profiles and corporate special programming, and airs as paid-programming in the United States reaching
potentially more than 100 million homes, visit www.newtothestreet.com.

New To The Street Contact
Vincent Caruso
Office: 631-465-0284
Cell: 631-682-8499
Email:
vince.caruso@newtothestreet.com

Friday, December 11th, 2015 Uncategorized Comments Off on (OGES) To Be Highlighted On FOX Business New To The Street Broadcast

(DSKX) Launches in Walmart Brazil

Pompano Beach, Fla., Dec. 09, 2015  — DS Healthcare Group’s flagship products are now selling in Walmart, one of Brazil’s largest retailers. With this addition, DS Laboratories further expands its global retail footprint as part of the company’s omni-channel approach and continued dedication to delivering its breakthroughs to consumers worldwide.

Brazilian customers can view our product selection and order at the following link: https://www.walmart.com.br/busca/?ft=ds+laboratories&PS=20

Brazil remains the world’s third largest consumer market for toiletries and stands as the world’s second largest market for men’s and children’s hair care products. The partnership with Walmart is expected to drive significant revenue growth for the company in Brazil.

About DS Healthcare Group

DS Healthcare Group Inc. is a leader in the development of biotechnology for topical therapies. It markets through online channels, specialty retailers, distributors, pharmacies, and salons. Its research has led to a highly innovative portfolio of personal care products and additional innovations in pharmaceutical projects. For more information on DS Health Group’s flagship brand, visit www.dslaboratories.com or www.facebook.com/DS.Labs

Forward-looking statements

Except for statements of historical fact, the matters discussed in this press release are forward-looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies, and are generally preceded by words such as “future,” “plan” or “planned,” “expects,” or “projected.” These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company’s control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing and marketing products, intense competition, and additional risks factors as discussed in reports filed by the company with the Securities and Exchange Commission, which are available at http://www.sec.gov

Investor Relations
DS Healthcare Group
(888) 404-7770 ext. 3
Investors@DSHealthgroup.com
Wednesday, December 9th, 2015 Uncategorized Comments Off on (DSKX) Launches in Walmart Brazil

(OHGI) Signs VoIP-Supply Contract With Globecomm Asia Pte. Ltd

One Horizon Delivers Its VoIP as a Service “VaaS” Solution

LIMERICK, IRELAND–(Dec 9, 2015) – One Horizon Group, Inc. (NASDAQ: OHGI) (“One Horizon”, “We” or the “Company”), which operates its own Chinese retail VoIP service, branded Aishuo, and develops and licenses its patented bandwidth-efficient mobile voice over Internet Protocol (“VoIP”) platform for smartphones, today announced that it has signed an agreement to deliver its revolutionary mobile VoIP service to Globecomm Asia Pte. Ltd (“Globecomm”), a leading provider of managed network communication solutions.

Globecomm is one of the premier satellite communications companies and is a pioneer in the design and integration of high quality satellite communications systems. Globecomm provides specialized communication products to support its global services to media, wireless, government, maritime and enterprise customers.

One Horizon further expands its licensee base through the delivery of a new Globecomm branded crew-calling VoIP app. Globecomm will purchase pre-paid calling cards from One Horizon and resell to ship crews through its network of maritime distribution channels. Globecomm has a global operation covering thousands of vessels. The revenue possibilities of One Horizon for this service are significant with our observed monthly revenue per vessel of one hundred and fifty US Dollars. Phone calls to friends and family will be carried through the One Horizon Public Switched Telephone Network (“PSTN”) in Asia, Europe and North America and billed to the crew on a pay-as-you-go basis at competitive rates.

One Horizon’s optimized technology was successfully trialed by Globecomm and is an ideal solution for smaller capacity internet connections like satellite internet because of its low bandwidth usage and high voice quality. The Company’s track record of successful maritime deployments with Singapore Telecommunications (“Singtel”) and Smart Communications in the Philippines (“Smart”) were key reference deployments over satellite that Globecomm considered as part of their selection process.

One Horizon Group CEO, Brian Collins, noted, “We were delighted to be able to expand our VoIP as a Service platform to even more high quality maritime operators like Globecomm. Our track record of success in low bandwidth conditions like those at sea or at remote mining sites is a key driver for these new revenue streams in our business. Both teams worked tirelessly to deliver a truly high quality and affordable calling solution for the crews aboard the Globecomm fleets.”

The Globecomm app can be downloaded from the Android Google Play store and from Apple’s iTunes App store.

About Globecomm Maritime

Globecomm Maritime provides ships, offshore platforms at sea and in port with a wide range of advanced, reliable and cost-effective maritime communications options ranging from voice and email connections up to full integration into broadband enterprise networks. With a global managed communications platform and engineering capabilities, Globecomm provides services ranging from L-band to VSAT services on C, Ku and Ka-Band with a worldwide coverage. For more information, please visit http://www.globecomm.com.

About One Horizon Group, Inc.

One Horizon Group Inc.’s business is to optimize communications over the Internet through its wholly owned subsidiary, Horizon Globex GmbH, Zug, which develops and markets one of the world’s most bandwidth-efficient mobile voice over Internet Protocol (VoIP) platforms for smartphones, and also offers a range of other optimized data Applications including messaging and mobile advertising. The company controls and operates the Aishuo mobile VoIP service in China. Horizon Globex GmbH is an ISO 9001 and ISO 20000-1 certified company. The Company has operations in Ireland, Switzerland, the United Kingdom, China, India, Singapore and Hong Kong. For more information on the Company, its products and services, please visit http://www.onehorizongroup.com.

Safe Harbor Statement

This news release may contain “forward-looking” statements. These forward-looking statements are only predictions and are subject to certain risks, uncertainties and assumptions that could cause actual results to differ from those in the forward looking-statements. Potential risks and uncertainties include such factors as uncertainty of consumer demand for the Company’s products, as well as additional risks and uncertainties that are identified and described in Company’s SEC reports. Actual results may differ materially from the forward-looking statements in this press release. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company does not undertake, and it specifically disclaims, any obligation to update any forward-looking statements to reflect occurrences, developments, events or circumstances after the date of such statement.

Contact:

Ted Haberfield
MZ Group
President – MZ North America
Direct: 760-755-2716
Mobile: 858-204-5055
Email Contact
www.mzgroup.us

Wednesday, December 9th, 2015 Uncategorized Comments Off on (OHGI) Signs VoIP-Supply Contract With Globecomm Asia Pte. Ltd

(ASYS) Announces Stock Repurchase Program

TEMPE, Ariz., Dec. 9, 2015  — Amtech Systems, Inc. (NASDAQ: ASYS), a global supplier of production and automation systems and related supplies for the manufacture of solar cells, semiconductors, and silicon wafers, today announced that its Board of Directors has authorized a new stock repurchase program of up to $4 million of the company’s outstanding common stock, par value $0.01 per share. This new program will commence immediately and is expected to be completed over the next 12 months.  As of December 3, 2015, Amtech had approximately 13.2 million shares of common stock outstanding.

Fokko Pentinga, President and Chief Executive Officer of Amtech, commented, “At current price levels, we believe Amtech’s common stock represents an attractive investment opportunity for the Company. We also believe we can continue to invest in the initiatives that are key to our future success as well as enhance the value of our Company by repurchasing common stock under this program.”

Under the program, shares may be repurchased from time to time in open market transactions at prevailing market prices or in privately negotiated purchases in accordance with federal securities laws. The actual timing, number, and value of shares repurchased under the program will be determined by management in its sole discretion and will depend on a variety of factors, such as market price, corporate and regulatory requirements, alternative investment opportunities, and other market and economic conditions. Repurchases under the program will be funded from available working capital. The program may be commenced, suspended or terminated at any time, or from time to time at management’s discretion and without prior notice.

About Amtech Systems, Inc.

Amtech Systems, Inc. is a global supplier of advanced thermal processing equipment to the solar, semiconductor / electronics, and LED manufacturing markets. Amtech’s equipment includes diffusion, ALD and PECVD systems and solder reflow systems. Amtech also supplies wafer handling automation and polishing equipment and related consumable products. The Company’s wafer handling, thermal processing and consumable products currently address the diffusion, oxidation, and deposition steps used in the fabrication of solar cells, LEDs, semiconductors, MEMS, printed circuit boards, semiconductor packaging, and the polishing of newly sliced sapphire and silicon wafers. Amtech’s products are recognized under the leading brand names Tempress SystemsTM, Bruce TechnologiesTM, PR HoffmanTM, R2D AutomationTM, SoLayTec, and BTU International.

Cautionary Note Regarding Forward-Looking Statements

Certain information contained in this press release is forward-looking in nature. All statements in this press release, or made by management of Amtech Systems, Inc. and its subsidiaries (“Amtech”), other than statements of historical fact, are hereby identified as “forward-looking statements” (as such term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “would,” “expects,” “plans,” “anticipates,” “intends,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology or our management are intended to identify such forward-looking statements.  Examples of forward-looking statements include statements regarding Amtech’s future financial results, operating results, business strategies, projected costs, products under development, competitive positions, and plans and objectives of Amtech and its management for future operations.  These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict.  The Form 10-K that Amtech filed with the Securities and Exchange Commission (the “SEC”) for the year-ended September 30, 2015, listed various important factors that could affect the company’s future operating results and financial condition and could cause actual results to differ materially from historical results and expectations based on forward-looking statements made in this document or elsewhere by Amtech or on its behalf.  These factors can be found under the heading “Risk Factors” in the Form 10-Ks and investors should refer to them.  Because it is not possible to predict or identify all such factors, any such list cannot be considered a complete set of all potential risks or uncertainties.  Except as required by law, we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:

Amtech Systems, Inc.Bradley C. Anderson

Chief Financial Officer

(480) 967-5146

irelations@Amtechsystems.com

ChristensenInvestor Relations

Patty Bruner

(480) 201-6075

pbruner@christensenir.com

Wednesday, December 9th, 2015 Uncategorized Comments Off on (ASYS) Announces Stock Repurchase Program

(SITO) Amends Licensing Agreement With Zoove

SITO Receives $550,000 Payment

JERSEY CITY, N.J., Dec. 9, 2015  — SITO Mobile Ltd. (NASDAQ:SITO), a leading mobile engagement platform, today announced an amendment to its patent licensing agreement with Zoove Corporation. Under the amended agreement, which was signed December 4, 2015, SITO Mobile received a payment of $550,000 which consisted of $100,000 in exchange for an amendment to the original licensing agreement and the acceleration of the remaining payments due to SITO Mobile under the original agreement which totaled $450,000.

“Receipt of this prepayment strengthens our balance sheet cash position as we close calendar year 2015,” said Jerry Hug, CEO of SITO Mobile. “This cash influx, combined with our strong current quarter revenue bookings, full-year growth projections, and positive EBITDA outlook, provides us with greater financial flexibility as we enter 2016.” Mr. Hug added, “This deal, along with a licensing agreement with a prominent national television broadcaster via our VideoStar entity, demonstrates SITO Mobile’s success in the early stages of monetizing our intellectual property. In 2016, monetization will become a priority across our diverse IP portfolio which now totals 22 patents.”

About SITO Mobile Ltd.

SITO Mobile provides a mobile engagement platform that enables brands to increase awareness, loyalty, and ultimately sales. For more information visit www.sitomobile.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, sales growth, our reliance on brand owners and wireless carriers, the possible need for additional capital as well other risks identified in our filings with the SEC. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

CONTACT: Investor Relations:
         Robert Haag
         IRTH Communications
         sito@irthcommunications.com
         866-976-4784

         Media Relations:
         Matthew Bretzius
         FischTank Marketing and PR
         matt@fischtankpr.com
Wednesday, December 9th, 2015 Uncategorized Comments Off on (SITO) Amends Licensing Agreement With Zoove

(TERP) Announces Improved Terms for the Acquisition of the Vivint Solar Portfolio

  • Expected purchase price reduced from $922 million to an estimated $799 million
  • TerraForm Power to only pay for installed systems at closing

BETHESDA, Md., Dec. 09, 2015  — TerraForm Power, Inc. (Nasdaq:TERP), a global owner and operator of clean energy power plants, today announced that it has revised and improved the terms of its agreement to acquire the Vivint Solar portfolio of installed residential rooftop solar systems in connection with the planned merger of Vivint Solar, Inc (NYSE:VSLR) with a subsidiary of SunEdison, Inc (NYSE:SUNE).

Improvements in the terms of the initial portfolio purchase

Under the revised agreement, the consideration paid will be calculated based on the number of megawatts (“MW”) of installed solar system in the acquired portfolio multiplied by $1.70 per watt, rather than the previously contemplated pre-set amount of $922 million before fees. At the estimated 470 MW portfolio size at closing, this would result in a purchase price of approximately $799 million before fees. This would represent a reduction of approximately $123 million in consideration paid for the portfolio compared to the original agreement – with approximately $30 million in savings from lower price per watt, and approximately $93 million from reduced MW volume, with the exact amount of such savings depending on the date of the closing of the merger between SunEdison and Vivint Solar, Inc., which is expected to occur in the first quarter of 2016. As a result of the amendment, TerraForm Power will no longer receive the originally contemplated short-term interest bearing note from SunEdison for residential solar systems that are not delivered on the closing date.

TerraForm Power also expects to be able to assume the aggregation facility that is already in place for the portfolio, thereby reducing its expected cash payment obligation by approximately $236 million to an estimated $563 million. TerraForm Power continues to maintain an unsecured bridge financing commitment from its lenders with respect to its payment obligations under the purchase agreement. In addition, TerraForm Power is actively evaluating selling some or all of this initial portfolio to a third party.

Improvements in the terms of the Take/Pay agreement

In addition, TerraForm Power and SunEdison also amended the terms of the contemplated take/pay agreement for the future acquisition of residential solar systems by TerraForm Power from SunEdison so that TerraForm Power’s obligation to purchase the cash equity interest in residential solar systems from SunEdison has been reduced to 400 MW in 2016 and 450 MW for each of the four years thereafter (the “Take/Pay agreement”).

Any assets that TerraForm Power acquires are to be purchased at fair market value, subject to downward price adjustment to achieve certain minimum returns. The Take/Pay agreement is required to secure the $300 million term loan facility that SunEdison intends to enter into to partially fund the Vivint Solar transaction.

As part of the revised terms for the Take/Pay agreement, TerraForm Power now has the ability to utilize an asset-backed-security structure to reduce its obligations under the Take/Pay agreement. In addition, SunEdison has also agreed to use reasonable best efforts to sell the residential systems that TerraForm Power would otherwise be obligated to purchase (under the Take/Pay agreement) to third parties.

Finally, based on SunEdison’s projections the term loan is expected to be repaid in full by December 31, 2016, at which point any obligations under the Take/Pay agreement would be extinguished. This anticipated repayment date is earlier than previously planned, as the term loan amount has been reduced from $500 million in the original financing to $300 million.

About TerraForm Power

TerraForm Power is a renewable energy leader that is changing how energy is generated, distributed and owned. TerraForm Power creates value for its investors by owning and operating clean energy power plants. For more information about TerraForm Power, please visit: http://www.terraformpower.com.

Forward-Looking Statements

This communication 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. These statements involve estimates, expectations, projections, goals, assumptions, known and unknown risks, and uncertainties and typically include words or variations of words such as  “anticipate,” “believe,” “intend,” “plan,” “predict,” “outlook,” “objective,” “forecast,” “target,” “continue,” “will,” or “may” or other comparable terms and phrases. All statements that address operating performance, events, or developments that TerraForm Power expects or anticipates will occur in the future are forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. Factors that might cause such differences include, but are not limited to, a variety of economic, competitive, and regulatory factors, many of which are beyond TerraForm Power’s control and are described in TerraForm Power’s Form 10-K for the fiscal year ended December 31, 2014, as well as additional factors it may describe from time to time in other filings with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2015. Forward-looking statements provide TerraForm Power’s current expectations or predictions of future conditions, events, or results and speak only as of the date they are made, but TerraForm Power can give no assurance that these expectations and assumptions will prove to have been correct and actual results may vary materially. TerraForm Power disclaims any obligation to publicly update or revise any forward-looking statement, except as required by law.

Contacts
Media:
Anne Granfield
Finsbury for TerraForm Power
Anne.Granfield@finsbury.com
+1 (646) 805-2033

Investors/Analysts:  
Brett Prior  
bprior@terraform.com  
+1 (650) 889-8628
Wednesday, December 9th, 2015 Uncategorized Comments Off on (TERP) Announces Improved Terms for the Acquisition of the Vivint Solar Portfolio

(FSNN) Acquires Cloud Services Provider Fidelity

Expands Fusion’s Pro Forma Annual Revenues to More Than $115 Million and Its Business Customer Base to Over 13,000

NEW YORK, NY–(December 09, 2015) – Fusion (NASDAQ: FSNN), a leading provider of cloud services, announced today that it has acquired Fidelity Voice and Data (“Fidelity”). Beachwood, Ohio-based Fidelity provides cloud voice, cloud connectivity, security, data center and cloud storage services to approximately 2,000 small, medium, and large business customers in the Midwest and throughout the U.S. Fusion expects to complete the integration of Fidelity by the end of the second quarter of 2016.

Total consideration in the transaction, which closed on December 8, 2015, was $30.0 million consisting of $28.5 million in cash and $1.5 million in Fusion common stock. The cash portion of the consideration was funded via Fusion’s existing bank credit facility and its cash balances. The transaction is immediately accretive to Fusion, with substantial opportunity for cost savings through elimination of redundancies.

Fidelity Acquisition Highlights

  • Contributes a revenue base of approximately $18 million per year, over 90% of which consists of monthly recurring revenues (MRR), growing nearly 10% organically through the first nine months of 2015
  • Adds approximately $6 million in annual pro forma Adjusted EBITDA after giving effect to projected cost synergies
  • Brings a customer base of approximately 2,000 businesses with a high average monthly revenue per customer (ARPU) of approximately $750 with a low churn rate of approximately 0.5% per month
  • Purchase price represents a valuation of 5.0x pro forma Adjusted EBITDA
  • Offers a highly comparable set of cloud solutions and network infrastructure which can be tightly integrated into Fusion’s existing platform
  • Contributes a strong team of experienced cloud technology professionals

Also, on December 7, 2015, Fusion completed an offering of common shares totaling approximately $6.0 million via its shelf registration statement, priced at the market close on December 4, 2015. The offering included significant additional commitments from Fusion’s largest institutional shareholder and from its chairman, its chief executive officer and other members of its board of directors.

Matthew Rosen, Fusion’s Chief Executive Officer, said, “The acquisition of Fidelity brings Fusion closer to its goal of building significant scale in the fragmented but rapidly growing cloud services market. Fidelity will also contribute to Fusion’s organic growth, accelerating Fusion’s progress over the last year in expanding its business. We intend to drive additional organic growth by cross-selling and up-selling Fusion’s comprehensive suite of integrated cloud solutions and leveraging the benefits of Fusion’s nation-wide network to Fidelity’s current customer base.

“Fusion adheres to a disciplined acquisition strategy based on a strict set of criteria. Fidelity met each of these criteria, including a business customer base with predictable, contracted recurring revenues, a high ARPU, and low churn, as well as a team of professionals and network assets that can be tightly integrated,” Mr. Rosen continued. “We expect to quickly integrate the Fidelity sales and marketing team, its network and back office infrastructure to accelerate the introduction of Fusion’s advanced, proprietary cloud solutions and national footprint to Fidelity’s customers.”

Don Hutchins, Fusion’s President and Chief Operating Officer, said, “Fidelity’s strong business profile means that the acquisition is immediately accretive to Fusion. We have also identified a range of specific cost savings opportunities which we expect to achieve as we integrate Fidelity into Fusion’s platform, just as we have accomplished with Fusion’s four previous acquisitions. We anticipate that these synergies will contribute significantly to our cash flow over the coming quarters.”

Mr. Hutchins added, “Fusion’s growth through acquisition has been enabled by the financial flexibility we gained through the new and expanded credit facility we established in August. By funding the Fidelity acquisition with borrowings under our new credit facility, we have lowered Fusion’s blended cost of debt to approximately 8% from 9% previously, and from 11.2% prior to establishing this facility. This, together with the common share offering we completed earlier this week, demonstrate our ongoing commitment to optimizing our balance sheet for sustainable growth.”

About Fusion

Fusion is a leading provider of integrated cloud solutions to small, medium and large businesses. Fusion’s advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including cloud communications, cloud connectivity, and cloud computing. Fusion’s innovative, yet proven cloud solutions lower our customers’ cost of ownership, and deliver new levels of security, flexibility, scalability, and speed of deployment. For more information, please visit www.fusionconnect.com.

Forward Looking Statements

Statements in this press release that are not purely historical facts, including statements regarding Fusion’s beliefs, expectations, intentions or strategies for the future, may be “forward-looking statements” under the Private Securities Litigation Reform Act of 1996. Such statements consist of any statement other than a recitation of historical fact and may sometimes be identified by the use of forward-looking terminology such as “may”, “expect”, “anticipate”, “intend”, “estimate” or “continue” or the negative thereof or other variations thereof or comparable terminology. The reader is cautioned that all forward-looking statements are speculative, and there are certain risks and uncertainties that could cause actual events or results to differ from those referred to in such forward-looking statements. Important risks regarding the company’s business include the company’s ability to raise additional capital to execute its comprehensive business strategy; the integration of businesses and assets following an acquisition; the company’s ability to comply with covenants included in its credit facilities; competitors with broader product lines and greater resources; emergence into new markets; natural disasters, acts of war, terrorism or other events beyond the company’s control; and other factors identified by Fusion from time to time in its filings with the Securities and Exchange Commission, which are available through http://www.sec.gov. However, the reader is cautioned that Fusion’s future performance could also be affected by risks and uncertainties not enumerated above.

Fusion Contact
Brian Coyne
212-201-2404
Email contact

Darrow Associates Contacts for Fusion

Jordan Darrow
(631) 367-1866
Email contact

Bernie Kilkelly
(516) 236-7007
Email contact

Wednesday, December 9th, 2015 Uncategorized Comments Off on (FSNN) Acquires Cloud Services Provider Fidelity

(CYTK) & Cure SMA Education Partnership for Spinal Muscular Atrophy

ELK GROVE VILLAGE, Ill. and SOUTH SAN FRANCISCO, Calif., Dec. 08, 2015  — Cure SMA and Cytokinetics Inc. (Nasdaq:CYTK), a leading muscle biology company, today announced an expanded partnership to increase education, awareness and fundraising for spinal muscular atrophy (SMA). As a National Gold Partner, Cytokinetics will lend support to key national and local initiatives to advance understanding of, and research toward potential treatments for SMA, a genetic disease that robs people of physical strength, taking away their ability to walk, eat or breathe.

Cytokinetics will sponsor the 2016 Annual SMA Conference, the largest event of its kind, bringing together families affected by SMA with researchers and clinicians, to network, learn, and collaborate, as well as the 2016 “Hope on the Hill” Congressional Dinner, uniting families with government and industry leaders, to collaborate on awareness-building, advancing treatments for SMA, and improving patient care. Locally, Cytokinetics will both sponsor and participate in the Concert for a Cure and the Northern California Walk-n-Roll.

“We are excited to expand on our ongoing partnership with Cytokinetics and are gratified to have them as our National Gold Partner,” said Kenneth Hobby, president of Cure SMA. “Cytokinetics’ contributions are crucial as we accelerate our momentum toward our ultimate goal of a treatment and cure for SMA.”

“Building awareness and education for SMA is a priority for us and we are pleased to take our partnership with Cure SMA to a new level,” said Robert I. Blum, President and Chief Executive Officer of Cytokinetics. “With no FDA-approved therapies available for people battling SMA, we are committed to advancing CK-107 into a Phase 2 clinical program and look forward to continued engagement with the patient community.”

About SMA

SMA is a severe neuromuscular disease that occurs in 1 in every 6,000 to 10,000 live births each year and is one of the most common fatal genetic disorders.  Spinal muscular atrophy manifests in various degrees of severity as progressive muscle weakness resulting in respiratory and mobility impairment. There are four types of SMA, named for time of the initial onset of muscle weakness and related symptoms: Type I (Infantile), Type II (Intermediate), Type III (Juvenile) and Type IV (Adult onset).  Life expectancy and disease severity varies by type of SMA from Type I, who have the worst prognosis and a life expectancy of no more than 2 years from birth, to the Type IV, who have a normal life span but with gradual weakness in the proximal muscles of the extremities resulting in mobility issues.  Few treatment options exist for these patients, resulting in a high unmet need for new therapeutic options to address symptoms and modify disease progression.

In collaboration with Astellas, Cytokinetics is developing CK-2127107 (CK-107), a novel skeletal muscle troponin activator as a potential treatment for people living with SMA and certain other debilitating diseases and conditions associated with neuromuscular or non-neuromuscular dysfunction, muscular weakness, and/or muscle fatigue. CK-107 is intended to slow the rate of calcium release from the regulatory troponin complex of fast skeletal muscle fibers and may improve muscle function and physical performance in people with SMA. Cytokinetics is planning to start a Phase 2 clinical trial of CK-107 in patients with SMA later this year.

About Cure SMA

Cure SMA is dedicated to the treatment and cure of spinal muscular atrophy (SMA)—a disease that takes away a person’s ability to walk, eat, or breathe. It is the number one genetic cause of death for infants.

Since 1984, Cure SMA has directed and invested in comprehensive research that has shaped the scientific community’s understanding of SMA. We are currently on the verge of breakthroughs in treatment that will strengthen our children’s bodies, extend life, and lead to a cure. We have deep expertise in every aspect of SMA—from the day-to-day realities to the nuances of care options—and until we have a cure, we’ll do everything we can to support children and families affected by the disease. Learn more about how you can help us reach a treatment and cure at www.cureSMA.org.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics’ lead drug candidate is tirasemtiv, a fast skeletal muscle activator, for the potential treatment of ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of ALS. Cytokinetics retains the right to develop and commercialize tirasemtiv. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel cardiac muscle activator, for the potential treatment of heart failure. Cytokinetics is collaborating with Astellas Pharma Inc. to develop CK-2127107, a fast skeletal muscle activator, for the potential treatment of spinal muscular atrophy.  Amgen holds an exclusive license worldwide to develop and commercialize omecamtiv mecarbil and Astellas holds an exclusive license worldwide to develop and commercialize CK-2127107. Both licenses are subject to Cytokinetics’ specified development and commercialization participation rights. For additional information about Cytokinetics, visit http://www.cytokinetics.com/.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities, including the conduct, design, enrollment and progress of the Phase 2 clinical trial of CK-107 in patients with SMA; the significance and utility of preclinical study and clinical trial results; and the properties and potential efficacy and safety profile of CK-107 and Cytokinetics’ other drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, further clinical development of tirasemtiv in ALS patients will require significant additional funding, and Cytokinetics  may be unable to obtain such additional funding on acceptable terms, if at all; the FDA and/or other regulatory authorities may not accept effects on slow vital capacity as a clinical endpoint to support registration of tirasemtiv for the treatment of ALS; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trial results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug Administration or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials, and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Amgen’s and Astellas’ decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil and CK-107, respectively; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products; Cytokinetics may be unable to enter into future collaboration agreements for its drug candidates and programs on acceptable terms, if at all; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.

Contact:

Cure SMA
Megan Lenz
Communications Manager
800.886.1762 x6319

Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3060
Tuesday, December 8th, 2015 Uncategorized Comments Off on (CYTK) & Cure SMA Education Partnership for Spinal Muscular Atrophy

(CNIT) Signs Pact for Installation of New Media Elevator Terminals in Sichuan Province

SHENZHEN, China, Dec. 8, 2015  — China Information Technology, Inc. (Nasdaq: CNIT), a leading provider of internet-based platforms, products and services in China, today said it entered into a strategic partnership agreement with Sichuan CAT Internet-of-Things Company, Ltd., an information technology solutions provider in Sichuan Province, to roll out CNIT’s new media elevator terminals across the Province.

CNIT expects 10,000 of the terminals to be sold and installed within the next several years, for which the company will receive one-time terminal sales and recurring monthly service fees over this period.

Equipped with CNIT’s proprietary mainboard and operating system, the terminals will display advertising and public information through Yunfa Net (www.pubds.com), the company’s cloud-based publication platform. Integrated with surveillance cameras and data collectors, the terminals will also transmit data on elevator operation to property management on a real-time basis.

Today’s agreement follows a September 2 announcement that the company will install 1,200 new media elevator terminals in Guiyang City in Guizhou Province and Longyan City in Fujian Province, and an August 12 announcement that CNIT will install 922 terminals in Huizhou City in Guangdong Province. To date, the company’s terminals have been successfully introduced into numerous strategic markets throughout China, an accomplishment that has strengthened CNIT’s brand recognition and the competitiveness of cloud-based new media solutions.

About China Information Technology, Inc.

China Information Technology is a leading Internet service company that makes advertising accessible and affordable for businesses of all sizes. CNIT provides cloud-based platform, exchange, and big data solutions enabling innovation and smart living in the education, health care, new media, finance and transportation sectors. Through continuous innovation, CNIT is aiming to leverage its proprietary Cloud-Application-Terminal technology to level the competitive landscape in the new media industry and deliver value for its shareholders, employees, customers, and the community. To learn more, please visit http://www.chinacnit.com.

Safe Harbor Statement

This press release may contain certain “forward-looking statements” relating to the business of China Information Technology, Inc., and its subsidiaries and other consolidated entities. All statements, other than statements of historical fact included herein, are “forward-looking statements” in nature within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, often identified by the use of forward-looking terminologies such as “believes”, “expects” or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company and its subsidiaries and other consolidated entities or persons acting on their behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

For further information, please contact:
China Information Technology, Inc.
Iris Yan
Tel: +86-755-8370-4767
Email: IR@chinacnit.com
http://www.chinacnit.com

or
Asia IR-PR
Jimmy Caplan
Tel: +512-329-9505
Email: jimmy@asia-irpr.com

or
Media Relations:
Asia IR-PR
Rick Eisenberg
Tel: +212-496-6828
Email: rick@asia-irpr.com

Tuesday, December 8th, 2015 Uncategorized Comments Off on (CNIT) Signs Pact for Installation of New Media Elevator Terminals in Sichuan Province

(CEMP) Initiates Phase 3 Clinical Trial of Taksta in Skin Infections

Pivotal Trial Designed to Demonstrate Non-Inferiority of Taksta Compared to Oral Zyvox(R) (linezolid)

CHAPEL HILL, N.C., Dec. 8, 2015  — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the first patient has been dosed in its Phase 3 clinical trial to evaluate the safety and efficacy of oral Taksta™ (CEM-102, sodium fusidate, the sodium salt of fusidic acid) as a potential treatment for acute bacterial skin and skin structure infections (ABSSSI). Cempra is developing Taksta exclusively in the United States as an oral treatment for ABSSSI and refractory bone and joint infections.

“Initiation of this Phase 3 trial for Taksta in ABSSSI marks an important milestone for this program, for our company and for the patients who suffer from these types of serious infections,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “In addition, we plan to initiate an exploratory trial for Taksta early next year in patients with refractory bone or joint infections. We believe increasing rates of bacterial resistance support the development of additional antibiotics and that Taksta, if approved, may provide an important treatment option for certain patient populations.”

Phase 3 Clinical Trial Design

The Phase 3 clinical trial is designed to evaluate the efficacy and safety of Taksta in the treatment of ABSSSI. Approximately 712 patients, 12 years old and up and diagnosed with ABSSSI, will be randomized one to one to receive either Taksta or Zyvox (linezolid). The primary objective is to demonstrate non-inferiority of Taksta compared to Zyvox for early clinical response (ECR) defined as the proportion of patients alive and achieving a ≥ 20% reduction from baseline in lesion size at 48-72 hours after start of study drug. Patients randomized to treatment with Taksta will receive 1500 mg by mouth every 12 hours for 2 doses, followed by 600 mg by mouth every 12 hours thereafter, until the end of therapy (10 days total). Patients randomized to the active comparator, linezolid, will be dosed with oral 600 mg every 12 hours for 10 days. Secondary outcome measures will assess the proportion of subjects with clinical success at their post-treatment evaluation 7 to 14 days after the end of treatment in the intent to treat and clinically evaluable patient groups. The incidence of adverse events will be recorded and clinical laboratory evaluations will be conducted. The design of this study conforms to FDA guidelines for conducting clinical trials in ABSSSI published in October 2013.

In September 2015, the FDA granted qualified infectious disease product (QIDP) designation to Taksta oral tablets for the indication of ABSSSI. The QIDP designation provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDA’s Fast Track program, and a potential five-year extension of exclusivity under the Hatch-Waxman Act.

About Taksta™

Cempra is developing Taksta (CEM-102, sodium fusidate, the sodium salt of fusidic acid) exclusively in the U.S. for acute bacterial skin and skin structure infections (ABSSSI) and is exploring its use for the long term oral treatment for refractory bone and joint infections. Fusidic acid is orally active against gram-positive bacteria, including all Staphylococcus aureus strains such as healthcare-acquired methicillin-resistant Staphylococcus aureus (HA-MRSA) and community-acquired (CA) MRSA. Taksta previously successfully completed a Phase 2 clinical trial in patients with ABSSSI, which is frequently caused by MRSA, demonstrating a tolerability profile and efficacy comparable to linezolid (sold under the brand name Zyvox®), the only oral antibiotic with FDA approval for the treatment of MRSA. A Phase 2 trial in patients with primarily staphylococcal infections of prosthetic hip and knee joints demonstrated that fusidic acid in combination with rifampin was generally comparable to intravenous standard of care antibiotics.

About Cempra, Inc.

Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases. Cempra’s two lead product candidates are currently in advanced clinical development. Solithromycin (CEM-101) has successfully completed two Phase 3 clinical trials for community-acquired bacterial pneumonia (CABP) and is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Solithromycin is also in a Phase 3 clinical trial for uncomplicated bacterial urethritis caused by Neisseria gonorrhoeae and chlamydia. Cempra is contracted with BARDA for the development of solithromycin for pediatric use. Three formulations, intravenous, oral capsules and a suspension formulation are in a Phase 1b trial in children from birth to 17 years of age. Taksta™ is Cempra’s second product candidate, which is being developed for acute bacterial skin and skin structure Infections (ABSSSI) and is also expected to be tested in an exploratory study for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra has also synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com.

Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; our and our strategic commercial partners’ ability to obtain FDA and foreign regulatory approval of our product candidates; our ability to commercialize and launch, whether on our own or with a strategic partner, any product candidate that receives regulatory approval; the costs, sources of funds, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; our anticipated capital expenditures and our estimates regarding our capital requirements; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and Taksta; our ability to produce and sell any approved products and the price we are able to realize for those products; our ability to retain and hire necessary employees and to staff our operations appropriately; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; our ability to compete in our industry; our dependence on the success of solithromycin and Taksta; innovation by our competitors; and our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.

CONTACT: Investor Contact:
         Robert H. Uhl
         Westwicke Partners, LLC
         (858) 356-5932
         robert.uhl@westwicke.com

         Media Contact:
         Tony Plohoros
         6 Degrees
         (908) 591-2839
         tplohoros@6degreespr.com
Tuesday, December 8th, 2015 Uncategorized Comments Off on (CEMP) Initiates Phase 3 Clinical Trial of Taksta in Skin Infections

(EGRX) to Receive $15 Million Payment for Approval of BENDEKA

-The Company will receive a 20% royalty on net sales of BENDEKA-

Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) announced that it has achieved the milestone which entitles the Company to receive a $15 million payment from Teva Pharmaceuticals Industries Ltd. resulting from the U.S. Food and Drug Administration (“FDA”) approval of BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine for the treatment of patients with chronic lymphocytic leukemia (“CLL”) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (“NHL”) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

The Company will receive a 20% royalty on net sales of BENDEKA. In addition, Eagle may earn an incremental step-up royalty upon the achievement of future milestones.

“We look forward to Teva’s successful commercialization of this new treatment option. We believe the $15 million milestone payment triggered by approval, coupled with future royalties of 20% on Teva’s net sales of BENDEKA, will expedite Eagle’s ability to deliver long-term, sustainable growth,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

BENDEKA was granted Orphan Drug Designations for both CLL and indolent B-cell NHL.

Under the February 2015 exclusive license agreement for BENDEKA, Teva is responsible for all U.S. commercial activities for the product including promotion and distribution.

About Eagle Pharmaceuticals, Inc.

Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s strategy is to utilize the FDA’s 505(b)(2) regulatory pathway. Additional information is available on the company’s website at www.eagleus.com.

Forward-Looking Statements

This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended and other securities laws. Forward-looking statements are statements that are not historical facts. Words such as “will,” “may,” “intends,” “anticipate(s),” “plan,” “enables,” “potentially,” “entitles,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including, but not limited to: ADD IN HERE; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; and other factors that are discussed in Eagle’s Annual Report on Form 10-K for the year ended September 30, 2014, and its other filings with the U.S. Securities and Exchange Commission. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to risks described in Eagle’s filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

 

For Eagle Pharmaceuticals, Inc.:
In-Site Communications, Inc.
Lisa M. Wilson, 212-452-2793
President

Tuesday, December 8th, 2015 Uncategorized Comments Off on (EGRX) to Receive $15 Million Payment for Approval of BENDEKA

(PIRS) Announces First Cancer Immunotherapy Collaboration

Agreement With Roche Leverages Proprietary Anticalin(R) Technology Platform

BOSTON, MA–(December 08, 2015) – Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel bio therapeutics through its proprietary Anticalin® technology platform, today announced a research collaboration and license agreement with Roche in cancer immunotherapy (CIT). Under the terms of the agreement, Pieris will discover, characterize and optimize Anticalin®-based drug candidates against an undisclosed target. Roche and Pieris will evaluate different drug formats against this target and advance them through preclinical development, with Roche being responsible for IND-enabling activities, clinical development and worldwide marketing of any resulting products. Pieris will receive an upfront payment of CHF 6.5 million (~$6.4 million USD) and committed research funding, and may receive development and regulatory-based milestone payments, sales-based milestone payments as well as mid single-digit to low double-digit royalties on any future product sales. If all milestones and other conditions are met, the total payments to Pieris could surpass CHF 415 million (~$409.3 million USD), excluding royalties.

“Our partnership with Roche is a significant step forward for Pieris,” commented Stephen Yoder, President and CEO of Pieris. “The decision by the leader in the development and commercialization of cancer biologics to collaborate with Pieris underscores the unique potential of Anticalin-based proteins as a differentiated class of immuno-oncology drugs. As we initiate this collaboration, we will continue to vigorously advance our fully proprietary programs, including our lead CD137-HER2 bispecific.”

With its immuno-oncology PRS-300 Series, which remains proprietary to the Company, Pieris is developing bispecific Anticalin-based protein therapeutics against a variety of tumor and immunomodulatory targets. These compounds, including its lead program PRS-343 (CD137/HER2 bispecific), aim to activate the immune system in the tumor microenvironment, with the goal of increasing efficacy as well as improving safety compared to existing approaches. This collaboration represents Pieris’ first partnered immuno-oncology program and leverages Pieris’ capability to address a target in multiple ways through Anticalin-based drug candidates in different formats.

About Pieris Pharmaceuticals:

Pieris Pharmaceuticals is a clinical stage biotechnology company that discovers and develops Anticalin-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes immuno-oncology multi-specifics tailored for the tumour micro-environment, an inhaled Anticalin to treat uncontrolled asthma and a half-life-optimized Anticalin to treat anemia. Proprietary to Pieris, Anticalins are a novel class of protein therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin®, Anticalins® are registered trademarks of Pieris. For more information visit www.pieris.com.

About Anticalins:

Anticalins are derived from lipocalins, small human proteins that naturally bind, store and transport a wide spectrum of molecules. Anticalins feature the typical four-loop variable region and a rigidly conserved beta-barrel backbone of lipocalins, which, together, form a shapeable cup-like binding pocket. Proprietary to Pieris, Anticalins are a novel class of protein therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies.

Anticalin®, Anticalins® are registered trademarks of Pieris.

Forward Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to novel technologies and methods; our business, research and product development plans; our liquidity and ability to fund our future operations; our ability to achieve certain milestones and receive future milestone or royalty payments; or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business, research and product development plans; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates; competition in the industry in which we operate and market conditions. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents we file with the SEC available at www.sec.gov, including without limitation the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and the Company’s Quarterly Reports on Form 10-Q.

Company Contact:
Pieris Pharmaceuticals, Inc.
Darlene Deptula-Hicks
SVP and Chief Financial Officer
+1-603-553-5803
deptula@pieris.com

Media Inquiries:
Gretchen Schweitzer
+49 172 861 8540
gschweitzer@macbiocom.com

Investor Relations Contact:
The Trout Group
Thomas Hoffmann
+1-646-378-2931
thoffmann@troutgroup.com

or

The Del Mar Consulting Group, Inc.
Robert Prag
President
+1-858-794-9500
bprag@delmarconsulting.com

Tuesday, December 8th, 2015 Uncategorized Comments Off on (PIRS) Announces First Cancer Immunotherapy Collaboration

(INVT) CEO Joe Beyers Comments on Corporate and Strategic Outlook

Company Participates in IP Dealmakers Forum

CAMPBELL, CA–(Dec 8, 2015) – While participating in the IP Dealmakers Forum in New York City (www.ipdealmakersforum.com), Inventergy Global, Inc. (NASDAQ: INVT) (“Inventergy” or the “Company”) CEO Joe Beyers commented on the Company’s recent corporate activities and strategic outlook.

“We remain committed to maintaining our NASDAQ listing,” Beyers stated. “To that end, yesterday we announced that we are effecting a one-for-ten reverse stock split previously approved by Inventergy’s stockholders. This reverse stock split took effect before trading today. I remain excited by our attractive short to mid-term potential deal pipeline, which we believe can create significant shareholder value.”

Mr. Beyers added, “We are also working with our financial and business partners to enable us to execute on our deal pipeline without the need to enter the equity market in the short-term. Additionally, we believe we have a significant market opportunity over the mid- to long-term and we plan to articulate this opportunity in more detail in future communications.”

About Inventergy Global, Inc.
Inventergy Global, Inc. (“Inventergy”) is a Silicon Valley-based intellectual property company dedicated to identifying, acquiring and licensing patented technologies of market-significant technology leaders. Led by IP industry pioneer and veteran Joe Beyers, the Company leverages decades of corporate experience, market and technology expertise, and industry connections to assist Fortune 500 companies in leveraging the value of their innovations to achieve greater returns.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements, estimates, forecasts and projections with respect to future performance and events, which constitute 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. Those statements include statements regarding the intent and belief or current expectations of the Company and its affiliates and subsidiaries and their respective management teams. Forward-looking statements are not statements of historical fact and often contain words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “will,” “should,” “seek” and similar expressions. Investors and prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including the risk factors set forth from time to time in our filings with the Securities and Exchange Commission. These risks could cause actual results to differ materially from those expressed or implied in the forward-looking statements. We make forward-looking statements based on currently available information, and we assume no obligation to, and expressly disclaim any obligation to, update or revise publicly any forward-looking statements made in this release, whether as a result of new information, future events or otherwise, except as required by law.

For more information about Inventergy, visit www.inventergy.com.

Tuesday, December 8th, 2015 Uncategorized Comments Off on (INVT) CEO Joe Beyers Comments on Corporate and Strategic Outlook

(BNTC) Hepatitis B Therapeutic Shows Positive Preclinical Results

SYDNEY, Dec. 7, 2015  — Benitec Biopharma Limited (ASX: BLT; NASDAQ: BNTC) is pleased to announce that initial in vitro data demonstrates efficacy of BB-HB-331, a DNA directed RNA interference (ddRNAi)-based therapeutic designed to treat and potentially cure hepatitis B with a single injection. The data was presented at the HEP DART 2015 conference on December 6, 2015 (US time). Collectively, the positive data strongly supports progression of BB-HB-331 into in vivo testing.

The data presented demonstrates that BB-HB-331 can effectively suppress multiple aspects of the hepatitis B virus (HBV) in infected human liver cells. Specifically, treatment with BB-HB-331 resulted in a 90% reduction in the levels of hepatitis B surface antigen (HBsAg) and e-antigen (HBeAg), as compared to untreated controls or liver cells treated with a construct that produces unrelated short hairpin RNA (shRNAs). In addition, the core antigen was also decreased by approximately 1 log. Pleasingly, BB-HB-331 treated cells showed at least an 85% reduction of intracellular hepatitis B DNA after only 23 days. The levels of cccDNA were correspondingly reduced by 66% in the same time frame.

The design and construction of BB-HB-331 mimics TT-034, the company’s lead product currently undergoing testing in the United States. Data from the preclinical and clinical development of TT-034 has been instrumental in the development of BB-HB-331.

Benitec’s Chief Scientific Officer, Dr David Suhy said, “The data demonstrates that BB-HB-331 produces robust knockdown of many of the critical parameters of active HBV infection. It gives us confidence to further develop the compound into follow-on in vivo studies, which are currently in progress. We anticipate that this data could provide the foundation to develop an anti-HBV therapeutic that is able to provide long term therapeutic benefit from a single injection.”

The full abstract will be available on Benitec’s website and on the HEP DART conference website (www.hepdart.com) following the end of the conference.

CONTACTS:
Carl Stubbings
Chief Business Officer
Tel: +61 (2) 9555 6986
Email: cstubbings@benitec.com

Annabel Murphy
Head of Investor Relations & Corporate Communications
Tel: +61 (2) 9555 6986
Email: amurphy@benitec.com

About Benitec Biopharma Limited:
Benitec Biopharma Limited is a biotechnology company (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW), which has developed a patented gene silencing technology delivered by gene therapy, called DNA directed RNA interference (ddRNAi) that has the potential to produce ‘one-shot’ cures for a range of diseases. The company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including hepatitis C and B, drug resistant lung cancer and wet age-related macular degeneration. Benitec has also licensed ddRNAi to other biopharmaceutical companies for applications including HIV/AIDS, Huntington’s disease, chronic neuropathic pain and retinitis pigmentosa. For further information regarding Benitec and its activities, please contact the persons below, or visit the Benitec website at www.benitec.com.

Monday, December 7th, 2015 Uncategorized Comments Off on (BNTC) Hepatitis B Therapeutic Shows Positive Preclinical Results

(ARWR) ARC-520 Leads to Consistent Immune Reactivation, Chronic Hepatitis B

Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, presented data at HEP DART 2015 showing that in chronically HBV-infected chimpanzees treated with ARC-520 in combination with nucleoside analogs, 7 of 9 (78%) exhibited signs of immune reactivation, which is likely a necessary step for achieving a functional cure of chronic HBV. One chimpanzee also exhibited an on-treatment therapeutic ALT flare and sustained virologic improvements 31 weeks off all treatment. ARC-520 is currently being studied in multiple Phase 2b global clinical trials.

“The hepatitis B virus causes infected cells to produce several proteins that suppress the host immune system, and, therefore, enable chronic viral infection by removing immune control. Our goal with ARC-520 is to reduce expression of those proteins and thereby enable reconstitution of the immune system. We now have shown that ARC-520 can do that, and not just in 1 or 2 infected chimps, but in 7 of the 9 chimps we treated, and this is a big deal,” said Christopher Anzalone, Ph.D., Arrowhead president and CEO. “ARC-520 deeply reduces HBV proteins and we believe the elevations in T-cell responsive serum cytokines observed in this study represent a strong proof of principle that ARC-520 can begin the process of immune reconstitution that many believe can lead to functional cure. These data are particularly encouraging when combined with our recent human data. Our Phase 2a clinical trial, which we reported at AASLD last month, showed that ARC-520 can dramatically reduce s-antigen, e-antigen, and core-related antigen in humans after a single dose. During the ongoing Phase 2b clinical trials, we are studying ARC-520 as monotherapy as well as in combination with other agents with the goal of identifying a regimen that leads to consistent functional cures.”

Christine Wooddell, Ph.D., director of liver targeting for Arrowhead, presented poster number 152 titled, “Sustained reduction of HBV DNA, RNA and proteins, and HBeAg seroconversion in a chronically HBV-infected chimpanzee treated with nucleoside analog/ARC-520 combination therapy.

In this presentation, Dr. Wooddell and co-authors show that 7 of 9 chimps, HBeAg positive and negative, exhibited indications of an immune response during ARC-520 treatment, as evidenced by elevations in T-cell responsive serum cytokines. Chimp Manetta exhibited deep decreases in HBV DNA, RNA and viral proteins during ARC-520/NUC treatment. The sustained induction of CXCL9 in Manetta was associated with a therapeutic ALT flare (218 U/L) followed by HBeAg seroconversion. Sustained virologic improvements were still observed 31 weeks after all treatment was removed. At this final time point, serum HBV DNA was 5 log10 lower, HBsAg was 1.7 log10 lower, and liver HBV RNA was 99% lower than pre-study.

HBV suppresses the immune system to allow chronic HBV infection. Interferon gamma (IFN-γ) is a key antiviral cytokine critical to innate and adaptive immune responses. IFN-γ produced by natural killer cells and natural killer T cells induces the chemokines CXCL9 and CXCL10 to mediate a T-cell response. An elevation of CXCL9 in the chimps studied is a promising sign of immune system reactivation.

8 out of 9 chimps exhibited episodes of serum cytokine CXCL9 elevation. For 7 chimps these occurred during ARC-520 treatment and in one chimp (Tattoo) these coincided with seroclearance of HBeAg that began prior to study.

To reduce viral replication prior to treatment with ARC-520, chimps were treated for 8-24 weeks with entecavir or in one case (chimp Michele) with entecavir and tenofovir. Following the NUC lead-in period, animals were administered ARC-520 intravenously at 4-week intervals (q4w). Dose levels were 2, 3, or 4 mg/kg ARC-520, along with maintenance doses of entecavir or entecavir and tenofovir. All 9 chimpanzees responded to ARC-520 with HBsAg reductions of 0.5 – 2.7 log10 at nadir, the greater reductions being in HBeAg positive chimps. HBsAg levels in all chimps continued to decrease with repeat dosing. Chimps were monitored for up to 31 weeks off all treatment.

Copies of presentation materials can be accessed by visiting the Events section of the company’s website at http://ir.arrowheadresearch.com/events.cfm.

About ARC-520

Arrowhead’s RNAi-based candidate ARC-520 is being investigated in the treatment of chronic HBV infection. The small interfering RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of the reverse transcription process where current standard of care nucleotide and nucleoside analogues act. Arrowhead is investigating ARC-520 specifically to determine if it can be used to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without seroconversion. Arrowhead is conducting Phase 2b multiple dose and combination studies in chronic HBV patients. Approximately 350-400 million people worldwide are chronically infected with the hepatitis B virus, which can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.

About Arrowhead Research Corporation

Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary Dynamic Polyconjugate delivery platform to develop targeted drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Arrowhead’s pipeline includes ARC-520 and ARC-521 for chronic hepatitis B virus, ARC-AAT for liver disease associated with alpha-1 antitrypsin deficiency, ARC-F12 for hereditary angioedema and thromboembolic diseases, and ARC-HIF2 for renal cell carcinoma.

For more information please visit http://www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company’s email list and receive news directly, please visit

http://ir.arrowheadresearch.com/alerts.cfm.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

DYNAMIC POLYCONJUGATES is a trademark of Arrowhead Research Corporation.

Source: Arrowhead Research Corporation

 

Arrowhead Research Corporation
Vince Anzalone, CFA
626-304-3400
ir@arrowres.com
or
Investor Relations:
The Trout Group
Chad Rubin, 646-378-2947
ir@arrowres.com
or
Media:
Russo Partners
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com

Monday, December 7th, 2015 Uncategorized Comments Off on (ARWR) ARC-520 Leads to Consistent Immune Reactivation, Chronic Hepatitis B

(TXMD) Positive Top-Line Results Phase 3 TX-004HR Trial in VVA

Conference Call Scheduled for Today at 4:45 p.m. ET to Discuss Results

TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced positive top-line results from its pivotal Phase 3 Rejoice Trial of TX-004HR, an investigational, applicator-free vaginal estradiol softgel, for the treatment of moderate to severe dyspareunia (vaginal pain during sexual intercourse), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. VVA is a chronic condition affecting nearly half of postmenopausal women in the United States that can significantly impair their quality of life.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20151207006324/en/

TX-004HR was evaluated at 25 mcg, 10 mcg, and 4 mcg doses. The pre-specified four co-primary endpoints were the change from baseline to week 12 in the percentage of vaginal superficial cells, percentage of vaginal parabasal cells, vaginal pH, and in participants’ self-reported severity of dyspareunia as the most bothersome symptom of VVA.

Statistical Significance of Results for Co-Primary Endpoints
(Based on Mean Change from Baseline to Week 12 Compared to Placebo)
25 mcg 10 mcg 4 mcg
Superficial Cells P < 0.0001 P < 0.0001 P < 0.0001
Parabasal Cells P < 0.0001 P < 0.0001 P < 0.0001
Vaginal pH P < 0.0001 P < 0.0001 P < 0.0001
Severity of Dyspareunia P = 0.0001 P = 0.0001 P = 0.0255

The 25 mcg dose of TX-004HR demonstrated highly statistically significant results at the p ≤ 0.0001 level compared to placebo across all four co-primary endpoints. The 10 mcg dose of TX-004HR demonstrated highly statistically significant results at the p ≤ 0.0001 level compared to placebo across all four co-primary endpoints. The 4 mcg dose of TX-004HR also demonstrated highly statistically significant results at the p ≤ 0.0001 level compared to placebo for the endpoints of vaginal superficial cells, vaginal parabasal cells, and vaginal pH; the change from baseline compared to placebo in the severity of dyspareunia was at the p = 0.0255 level.

Statistical improvement over placebo was also observed for all three doses at the first assessment at week two and sustained through week 12. The pharmacokinetic data for all three doses demonstrated low systemic absorption, supporting the previous Phase 1 trial data. TX-004HR was well tolerated, and there were no clinically significant differences compared to placebo-treated participants with respect to adverse events. There were no drug-related serious adverse events reported. Additional presentations of this data are included at the end of this press release.

“We are extremely encouraged that all three doses of TX-004HR studied in the Rejoice Trial demonstrated positive results,” said TherapeuticsMD CEO Robert G. Finizio. “With efficacy observed as early as two weeks and the convenience of the applicator-free vaginal softgel, we believe that, if approved, TX-004HR has the potential to offer a highly differentiated, new treatment option that meets the needs of the millions of postmenopausal women with VVA who are suffering from pain during sexual intercourse. We look forward to sharing the Rejoice Trial results and to submitting a New Drug Application for TX-004HR to the Food and Drug Administration as soon as the first half of 2016.”

TX-004HR features SYMBODATM technology, which enables partial and complete solubilization of estradiol into medium-chain fatty acid oils often derived from coconut oil. This allows for the production of cohesive, stable formulations and provides content uniformity and accuracy of dosing strengths for TX-004HR.

“Nearly half of all postmenopausal women have VVA, yet few are treated with prescription therapy,” said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. “The highly statistically significant efficacy results and safety profile from the Rejoice Trial are very promising. We are excited about the potential for TX-004HR to be a new treatment option with low systemic absorption for women with VVA suffering from moderate to severe dyspareunia.”

Safety and efficacy analyses of the Rejoice Trial data are ongoing. TherapeuticsMD plans to submit Rejoice Trial results for presentation at future scientific meetings and for publication in peer reviewed journals.

Rejoice Trial Design

The Rejoice Trial was a randomized, double-blinded, placebo-controlled, multicenter Phase 3 clinical trial designed to evaluate the safety and efficacy of three doses of TX-004HR — 25 mcg, 10 mcg and 4 mcg — compared to placebo for the treatment of moderate to severe dyspareunia in postmenopausal women with VVA. The co-primary efficacy endpoints are change from baseline to week 12 in the percentage of vaginal superficial cells, percentage of vaginal parabasal cells, vaginal pH, and severity of moderate to severe dyspareunia as the most bothersome symptom of VVA. The trial enrolled 764 postmenopausal women (40 to 75 years old) experiencing moderate to severe dyspareunia at approximately 89 sites across the United States and Canada. Trial participants were randomized to receive either TX-004HR at 25 mcg (n=190), 10 mcg (n=191), or 4 mcg (n=191) doses or placebo (n=192) for a total of 12 weeks, all administered once daily for two weeks and then twice weekly (approximately three to four days apart) for ten weeks.

Conference Call and Webcast

TherapeuticsMD will host a conference call today, during which management will discuss the top-line results of the pivotal Phase 3 Rejoice Trial. Details for the call are:

Date: December 7, 2015

Time: 4:45 p.m. ET

Telephone Access (US): (866) 665-9531

Telephone Access (International): (724) 987-6977

Access Code for All Callers: 98389089

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, under the “Investors & Media” section.

About TX-004HR

TX-004HR is an investigational bio-identical 17β-estradiol vaginal drug product candidate being studied for the treatment of moderate to severe dyspareunia, a symptom of VVA, also known as genitourinary syndrome of menopause (GSM), in postmenopausal women. TX-004HR utilizes a unique applicator-free vaginal estradiol softgel capsule technology.

About Vulvar and Vaginal Atrophy (VVA)

An estimated 32 million women in the United States are currently suffering from symptoms of VVA1, and only 2.3 million (7%) are currently being treated with prescription therapy.2,3 The burden of VVA in the United States may increase due to aging of the population.4 Furthermore, due to increasing longevity,4 women may now suffer from VVA or other conditions related to decreased reproductive hormone levels for over one-third of their lives.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s clinical development pipeline includes two phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins under the vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com and www.bocagreenmd.com.

Forward Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize its hormone therapy drug candidates and obtain additional financing necessary therefor; the length, cost and uncertain results of the company’s clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the company’s hormone therapy drug candidates; the company’s reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.

References

1 Kingsberg SA, Wysocki S, Magnus L, et al. Vulvar and vaginal atrophy in postmenopausal women: Findings from the Revive (REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013;10:1790-1799.

2 Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin Proc. 2010;85:87-94.

3 North American Menopause Society. The role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 position statement of The North American Menopause Society. Menopause. 2007; l4(3 Pt 1):355-69.

4 US Census Bureau. Age and Sex Composition: 2010. 2011 May. Report No.: C2010BR-03.

 

TherapeuticsMD
Investors
Dan Cartwright, 561-961-1900
Chief Financial Officer,
Dan.Cartwright@TherapeuticsMD.com
or
Media
Elliot Fox, 212-257-6724
Director, Media & Engagement, WCG
efox@w2ogroup.com

Monday, December 7th, 2015 Uncategorized Comments Off on (TXMD) Positive Top-Line Results Phase 3 TX-004HR Trial in VVA

(XBIT) Positive Results EU Phase III Xilonix Study in Colorectal Cancer

Company Now Seeking Marketing Authorization With EMA & Other Jurisdictions

AUSTIN, Texas, Dec. 7, 2015  — XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today that it met the primary endpoint in its European Phase III clinical study of Xilonix™, a novel therapy for patients with symptomatic, advanced colorectal cancer. Patients enrolled in the double-blinded, placebo-controlled study had refractory, metastatic colorectal cancer and suffered from cancer-associated symptoms such as fatigue, pain, elevated inflammatory markers, weight loss and reduced physical ability at baseline. Patients were randomized 2:1 to receive either Xilonix therapeutic antibody or placebo, respectively.

Significantly more patients treated with Xilonix were responders compared to those given placebo.  One-third (33%) of the 207 patients randomized to Xilonix treatment met responder criteria, compared to less than one-fifth (19%) of the 102 placebo patients (p=0.009). Based on a modified intent to treat analysis plan, patients with missing endpoint data or those who received Xilonix instead of placebo were considered non-responders.  In total, there were 333 patients enrolled in the study. As per the prospective analysis plan, 24 patients who failed to receive either Xilonix or placebo were excluded from analysis.

Patients were assessed for anti-tumor activity using a novel co-primary endpoint. X-ray imaging was used to quantify change in lean body mass and health status was assessed based on patient-reported outcomes using the European Organization of Research and Evaluation of Cancer instrument (EORTC-QLQ-C30). The study outcome was based on a responder analysis, such that patients with conserved or improved lean body mass and EORTC-QLQ-C30 performance over the treatment period were considered responders. Responder analysis was determined after 4 cycles of therapy (8 weeks). The Company has been developing the responder analysis as a novel surrogate measure of anti-cancer activity.

The Xilonix therapeutic antibody uniquely blocks the inflammation that is believed to support tumor growth, spread and symptomatic effects of the disease. In the presence of progressive disease, patient condition is known to deteriorate. In the context of an antitumor therapy, the control or reversal of symptoms related to disease is considered to be evidence of anticancer activity and a prognosticator of better survival.

This study, developed in collaboration with the EMA, represents the first use of such a responder analysis in a controlled study for the development of an anticancer agent. Xilonix is thus the first anticancer agent evaluated using surrogate measures based on conservation of patient health status, and is believed to be the first anticancer therapy to demonstrate an ability to conserve or improve patient health status with treatment.

The Company plans to proceed with the marketing authorization process with the EMA and other jurisdictions.

John Simard, CEO of XBiotech, stated, “We are gratified to announce these findings with Xilonix. The ability of Xilonix to help improve the health of patients with cancer has been demonstrated. We look forward to seeking approval to deliver this unprecedented cancer agent to patients.”

About XBiotech

XBiotech is pioneering a new era in the discovery and development of targeted antibodies based on its True HumanTM technology. The company’s mission is to rethink the way antibody medicines are discovered and commercialized by advancing its robust pipeline of truly natural human antibodies for treating serious diseases such as cancer, inflammatory conditions and infectious diseases. XBiotech’s lead product, Xilonix™, is a potential breakthrough antibody therapy that is currently the subject of two pivotal clinical studies for treating patients with advanced colorectal cancer. Xilonix specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis, growth and spread of tumors, as well as mediate symptoms such as metabolic dysregulation, fatigue and anxiety associated with advanced cancer. XBiotech’s broad pipeline of True Human antibodies are able to potentially deliver unmatched safety and efficacy because they are cloned directly from individual donors who possess natural immunity against certain targeted diseases. As such, True Human antibodies retain their natural physiology and tolerance profile, having passed the rigors of immune selection in the body. For more information, visit www.xbiotech.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements, including declarations regarding management’s beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “could,” “expects,” “plans,” “contemplate,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “intend” or “continue” or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the “Risk Factors” section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CONTACT: Ashley Otero
         XBiotech
         aotero@xbiotech.com
         512.386.2930

         Tiberend Strategic Advisors, Inc.:

         Joshua Drumm, Ph.D. (investors)
         jdrumm@tiberend.com
         212.375.2664

         Janine McCargo (media)
         jmccargo@tiberend.com
         646.604.5150
Monday, December 7th, 2015 Uncategorized Comments Off on (XBIT) Positive Results EU Phase III Xilonix Study in Colorectal Cancer

(GMCR) $92 Per Share Cash Acquisition By JAB Holding Company-Led Investor Group

Keurig Green Mountain to Become a Privately Owned Company Operating Independently as Part of JAB’s Global Coffee Platform

Keurig Green Mountain, Inc. (“Keurig Green Mountain”) (NASDAQ:GMCR), a personal beverage system company that has revolutionized the way consumers create and enjoy beverages, and JAB Holding Company (“JAB”) today announced that the companies have entered into a definitive merger agreement under which a JAB-led investor group will acquire Keurig Green Mountain for $92.00 per share in cash, or a total equity value of approximately $13.9 billion. The agreement, which has been unanimously approved by Keurig Green Mountain’s Board of Directors, represents a premium of approximately 77.9% over Keurig Green Mountain’s closing stock price on December 4, 2015.

JAB is acquiring Keurig Green Mountain in partnership with strategic minority investors who are already shareholders in Jacobs Douwe Egberts B.V., (“JDE”), including Mondelēz International and entities affiliated with BDT Capital Partners. At the close of the transaction, Keurig Green Mountain will be privately owned and will continue to be operated independently by the company’s management team and employees. Keurig Green Mountain will remain headquartered in Waterbury, VT.

Bart Becht, Chairman at JAB commented, “Keurig Green Mountain represents a major step forward in the creation of our global coffee platform. It is a fantastic company that uniquely brings together premium coffee brands and new beverage dispensing technologies like the famous Keurig single serve machine. Keurig Green Mountain will operate as an independent entity to ensure it will further build on its coffee & technology strength and continue to serve all its partners to the best of its abilities.”

Brian Kelley, President and CEO of Keurig Green Mountain commented, “This transaction will deliver significant cash value for our shareholders and offers an exciting new chapter for our customers, partners and employees by combining Keurig Green Mountain with JAB’s global coffee platform. JAB fully supports Keurig Green Mountain’s culture and values as we continue to pursue our commitment to deliver innovative beverage solutions for consumers at the touch of a button.”

“The Coca-Cola Company is fully supportive of this transaction,” said Muhtar Kent, Chairman and CEO, The Coca-Cola Company. “We have enjoyed a strong partnership with Keurig Green Mountain, and will continue our collaboration with JAB in order to capitalize on the growth opportunities in the single-serve, pod-based segment of the cold beverage industry. We look forward to working with JAB, an experienced operator with a successful track record of investing in and growing consumer companies.”

Irene Rosenfeld, Chairman and CEO of Mondelēz International, commented, “Keurig Green Mountain is a strategic asset that provides immediate access to the U.S., the largest coffee market in the world, and to on-demand, the fastest growing segment of the market. By leveraging our existing investment in JDE and not contributing incremental capital, we have the opportunity to diversify our participation in the global coffee category, while continuing to invest in our core snacking business to deliver significant value for our shareholders over the long term.”

Transaction Details

The transaction is not subject to a financing condition and is expected to close during the first calendar quarter of 2016, subject to customary closing conditions, including receipt of regulatory approvals. The transaction requires the affirmative vote of holders of a majority of Keurig Green Mountain’s outstanding shares entitled to vote thereon.

BofA Merrill Lynch and Credit Suisse provided fairness opinions to Keurig Green Mountain.

About Keurig Green Mountain, Inc.

Keurig Green Mountain, Inc. (Keurig) (NASDAQ:GMCR) is reimagining how beverages can be created, personalized, and enjoyed, fresh-made in homes and workplaces. We are a personal beverage system company revolutionizing the beverage experience through the power of innovative technology and strategic brand partnerships. With an expanding family of more than 80 beloved brands and more than 575 beverage varieties, our Keurig® hot and Keurig® KOLD™ beverage systems deliver great taste, convenience, and choice at the push of a button. As a company founded on social responsibility, we are committed to using the power of business to brew a better world through our work to build resilient supply chains, sustainable products, thriving communities, and a water-secure world. For more information visit: www.KeurigGreenMountain.com. To purchase Keurig products: www.keurig.com, www.keurig.ca, www.keurig.co.uk. Keurig routinely posts information that may be of importance to investors in the Investor Relations section of its website, www.KeurigGreenMountain.com, including news releases and its complete financial statements, as filed with the U.S. Securities and Exchange Commission (“SEC”). The Company encourages investors to consult this section of its website regularly for important information and news. Additionally, by subscribing to the Company’s automatic email news release delivery, individuals can receive news directly from Keurig as it is released.

About JAB Holding Company

JAB Holding Company is a privately held group focused on long-term investments in companies with premium brands, attractive growth and strong margin dynamics in the Consumer Goods category. The group’s portfolio includes a controlling stake in Jacobs Douwe Egberts (JDE), the largest pure-play FMCG coffee company in the world, a controlling stake in Coty Inc., a global leader in beauty, and controlling stakes in luxury goods companies including Jimmy Choo, Bally and Belstaff. JAB also has controlling stakes in Peet’s Coffee & Tea, a premier specialty coffee and tea company, Caribou Coffee Company, a specialty retailer of high-quality premium coffee products, Einstein Noah Restaurant Group, Inc., a leading company in the quick-casual segment of the restaurant industry, Espresso House, the largest branded coffee shop chain in Scandinavia, and Baresso Coffee A/S, the first and largest branded coffee shop chain in Denmark. JAB also owns a minority stake in Reckitt Benckiser PLC, a global leader in health, hygiene and home products. In July 2015, Coty announced it had reached a definitive agreement to purchase some of Procter & Gamble’s beauty brands to create one of the world’s largest cosmetic companies. JAB is overseen by its three Senior Partners, Peter Harf, Bart Becht (Chairman) and Olivier Goudet (CEO). For more information, please visit the company’s website at: http://www.jabholco.com.

Forward-Looking Statements

Certain information in this press release constitutes “forward-looking statements.” Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. They often include words such as “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “seeks” or words of similar meaning, or future or conditional verbs, such as “will,” “should,” “could,” “may,” “aims,” “intends,” or “projects.” However, the absence of these words or similar expressions does not mean that a statement is not forward-looking. These statements may relate to risks or uncertainties associated with: the satisfaction of the conditions precedent to the consummation of the proposed transaction, including, without limitation, the receipt of stockholder and regulatory approvals; unanticipated difficulties or expenditures relating to the proposed transaction; legal proceedings, judgments or settlements, including those that may be instituted against the Company, its board of directors, executive officers and others following the announcement of the proposed transaction; disruptions of current plans and operations caused by the announcement and pendency of the proposed transaction; potential difficulties in employee retention due to the announcement and pendency of the proposed transaction; the response of customers, distributors, suppliers, business partners and regulators to the announcement of the proposed transaction; and other factors described in the Company’s annual report on Form 10-K for the Company’s fiscal year ended September 26, 2015 filed with the SEC. The Company can give no assurance that the expectations expressed or implied in the forward-looking statements contained herein will be attained. The forward-looking statements are made as of the date of this press release, and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof.

Additional Information Regarding the Transaction and Where to Find It

This communication does not constitute an offer to sell or the solicitation of an offer to buy the securities of Keurig Green Mountain, Inc. (the “Company”) or the solicitation of any vote or approval. This communication is being made in respect of the proposed merger transaction involving the Company, Acorn Holdings B.V. and Maple Holdings Acquisition Corp. The proposed merger of the Company will be submitted to the stockholders of the Company for their consideration. In connection therewith, the Company intends to file relevant materials with the SEC, including a definitive proxy statement. However, such documents are not currently available. The definitive proxy statement will be mailed to the stockholders of the Company. BEFORE MAKING ANY VOTING OR ANY INVESTMENT DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT REGARDING THE PROPOSED TRANSACTION AND ANY OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders may obtain free copies of the definitive proxy statement, any amendments or supplements thereto and other documents containing important information about the Company, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on the Company’s website at www.KeurigGreenMountain.com under the heading “SEC Filings” within the “Financial Information” section in the “Investors” portion of the Company’s website. Stockholders of the Company may also obtain a free copy of the definitive proxy statement and any filings with the SEC that are incorporated by reference in the definitive proxy statement by contacting the Company’s Investor Relations Department at (646) 762-8095.

Participants in the Solicitation

The Company and its directors, executive officers and certain other members of management and employees may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of the Company is set forth in its proxy statement for its 2015 annual meeting of stockholders, which was filed with the SEC on December 12, 2014, its annual report on Form 10-K for the fiscal year ended September 26, 2015, which was filed with the SEC on November 19, 2015, and in subsequent documents filed with the SEC, each of which can be obtained free of charge from the sources indicated above. Other information regarding the participants in the proxy solicitation of the stockholders of the Company and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the preliminary and definitive proxy statements and other relevant materials to be filed with the SEC when they become available.

 

Keurig Green Mountain
For Media:
Joele Frank, Wilkinson Brimmer Katcher
Dan Katcher / Matthew Sherman / Averell Withers
212-355-4449
or
For Investors:
Kristi Bonner, 646-762-8095
kristi.bonner@keurig.com
or
JAB Holding Company
Abernathy MacGregor Group
Tom Johnson/Pat Tucker
212-371-5999

Monday, December 7th, 2015 Uncategorized Comments Off on (GMCR) $92 Per Share Cash Acquisition By JAB Holding Company-Led Investor Group

(GST) Declares Monthly Cash Dividend

HOUSTON, Dec. 4, 2015  — Gastar Exploration Inc. (NYSE MKT: GST) (“Gastar”) announced today that it has declared monthly cash dividends on its 8.625% Series A Preferred Stock (“Series A Preferred Stock”) and its 10.75% Series B Preferred Stock (“Series B Preferred Stock”) for December 2015.

The dividend on the Series A Preferred Stock is payable on December 31, 2015 to holders of record at the close of business on December 15, 2015.  The December 2015 dividend payment will be an annualized 8.625% per share, which is equivalent to $0.179688 per share, based on the $25.00 per share liquidation preference of the Series A Preferred Stock.  The Series A Preferred Stock is currently listed on the NYSE MKT and trades under the ticker symbol “GST.PRA.”

The dividend on the Series B Preferred Stock is payable on December 31, 2015 to holders of record at the close of business on December 15, 2015.  The December 2015 dividend payment will be an annualized 10.75% per share, which is equivalent to $0.223958 per share, based on the $25.00 per share liquidation preference of the Series B Preferred Stock.  The Series B Preferred Stock is currently listed on the NYSE MKT and trades under the ticker symbol “GST.PRB.”

About Gastar

Gastar Exploration Inc. is an independent energy company engaged in the exploration, development and production of oil, condensate, natural gas and natural gas liquids in the United States. Gastar’s principal business activities include the identification, acquisition, and subsequent exploration and development of oil and natural gas properties with an emphasis on unconventional reserves, such as shale resource plays. In Oklahoma, Gastar is developing the primarily oil-bearing reservoirs of the Hunton Limestone horizontal play and is testing other prospective formations on the same acreage, including the Meramec Shale and the Woodford Shale, which is referred to as the STACK Play and emerging prospective plays in the shallow Oswego formation and in the Osage formation, a deeper bench of the Mississippi Lime located below the Meramec Shale. In West Virginia, Gastar has developed liquids-rich natural gas in the Marcellus Shale and has drilled and completed two successful dry gas Utica Shale/Point Pleasant wells on its acreage.  Gastar has engaged Tudor, Pickering, Holt & Co. to market certain of its Marcellus Shale and Utica Shale/Point Pleasant assets located in Marshall and Wetzel Counties, West Virginia.  For more information, visit Gastar’s website at www.gastar.com.

Safe Harbor Statement and Disclaimer

This news release includes “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.  Forward-looking statements give our current expectations, opinion, belief or forecasts of future events and performance.  A statement identified by the use of forward-looking words including “may,” “expects,” “projects,” “anticipates,” “plans,” “believes,” “estimate,” “will,” “should,” and certain of the other foregoing statements may be deemed forward-looking statements.  Although Gastar believes that the expectations reflected in such forward-looking statements are reasonable, these statements involve risks and uncertainties that may cause actual future activities and results to be materially different from those suggested or described in this news release.  These include risks inherent in oil and natural gas drilling and production activities, including risks with respect to continued low or further declining prices for oil and natural gas that could result in downward revisions to the value of proved reserves or otherwise cause Gastar to further delay or suspend planned drilling and completion operations or reduce production levels, which would adversely impact cash flow; risks relating to the availability of capital to fund drilling operations that can be adversely affected by adverse drilling results, production declines and declines in oil and natural gas prices; risks regarding Gastar’s ability to meet financial covenants under its indenture or credit agreements or the ability to obtain amendments or waivers to effect such compliance; risks of fire, explosion, blowouts, pipe failure, casing collapse, unusual or unexpected formation pressures, environmental hazards, and other operating and production risks, which may temporarily or permanently reduce production or cause initial production or test results to not be indicative of future well performance or delay the timing of sales or completion of drilling operations; delays in receipt of drilling permits; risks relating to unexpected adverse developments in the status of properties; borrowing base redeterminations by Gastar’s banks; risks relating to the absence or delay in receipt of government approvals or third-party consents; risks relating to Gastar’s ability to realize the anticipated benefits from acquired assets; and other risks described in Gastar’s Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission (“SEC”), available at the SEC’s website at www.sec.gov.  Gastar’s actual sales production rates can vary considerably from tested initial production rates depending upon completion and production techniques and its primary areas of operations are subject to natural steep decline rates. By issuing forward-looking statements based on current expectations, opinions, views or beliefs, Gastar has no obligation and, except as required by law, is not undertaking any obligation, to update or revise these statements or provide any other information relating to such statements

Contacts:
Gastar Exploration Inc.
J. Russell Porter, Chief Executive Officer
713-739-1800 / rporter@gastar.com

Investor Relations Counsel:
Lisa Elliott / lelliott@DennardLascar.com
Dennard-Lascar Associates: 713-529-6600

Friday, December 4th, 2015 Uncategorized Comments Off on (GST) Declares Monthly Cash Dividend

(GLPG) Increases Share Capital Through Warrant Exercises

Mechelen, Belgium; 4 December 2015 – Galapagos NV (Euronext & NASDAQ: GLPG) announced a share capital increase arising from warrant exercises. 

Galapagos issued 63,500 new ordinary shares on 4 December 2015, for a total capital increase (including issuance premium) of €590,800.00.

Pursuant to the rules of the warrant exercise program of Galapagos’ Executive Committee adopted in 2013, Executive Committee members automatically are committed to exercise a minimum number of warrants, subject to certain conditions.  Accordingly, CEO Onno van de Stolpe exercised 10,000 warrants and has consequently increased his holding to a total of 538,289 shares; two other Executive Committee members exercised an aggregate amount of 5,000 warrants.

In accordance with Belgian transparency legislation[1], Galapagos notes that its total share capital currently amounts to € 211,388,857.22; the total number of securities conferring voting rights is 39,076,342, which is also the total number of voting rights (the “denominator”), and all securities conferring voting rights and all voting rights are of the same category.  The total number of rights (warrants) to subscribe to not yet issued securities conferring voting rights is 2,805,692, which equals the total number of voting rights that may result from the exercise of these warrants.  Galapagos does not have any convertible bonds or shares without voting rights outstanding.

About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action.  Our pipeline comprises three Phase 2, three Phase 1 and five pre-clinical, and 20 discovery studies in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications.  We are focused on the development and commercialization of novel medicines that will improve people’s lives.  The Galapagos group, including fee-for-service subsidiary Fidelta has approximately 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia.  More information at www.glpg.com.

Contacts

Investors:                                                       Media:
Elizabeth Goodwin                                              Evelyn Fox
VP IR & Corporate Communications                     Director Communications
Tel:      +1 781 460 1784                                    Tel:   +31 6 53 591 999
ir@glpg.com                                                      communications@glpg.com

Forward-looking statements
This release may contain forward-looking statements, all of which involve certain risks and uncertainties.  These statements are often, but not always, made through the use of words or phrases such as “anticipates,” “believes,” “continues,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “seeks,” “stands to,” “we believe,” “will,” “we intend,” as well as similar expressions.  Such forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements.  In addition, even if Galapagos’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods.  Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from Galapagos’ ongoing clinical research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons), Galapagos’ reliance on collaborations with third parties, and estimating the commercial potential of Galapagos’ product candidates.  A further list and description of these risks, uncertainties and other risks can be found in Galapagos’ Securities and Exchange Commission (SEC) filings and reports, including in Galapagos’ prospectus filed with the SEC on 14 May 2015 and future filings and reports filed by Galapagos with the SEC.  Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.  These forward-looking statements speak only as of the date of publication of this document.  Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

Friday, December 4th, 2015 Uncategorized Comments Off on (GLPG) Increases Share Capital Through Warrant Exercises

(AMGN) First Biosimilar Marketing Authorization Application Submitted to EMA

Supported By Phase 3 Studies in Moderate-to-Severe Plaque Psoriasis and Moderate-to-Severe Rheumatoid Arthritis

THOUSAND OAKS, Calif., Dec. 4, 2015  — Amgen (NASDAQ:AMGN) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501, a biosimilar candidate to Humira® (adalimumab). Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen’s first biosimilar to be submitted for approval in the European Union.

“The submission of Amgen’s first biosimilar application to the EMA is an exciting milestone as we seek to expand our global patient reach,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Patients with chronic inflammatory conditions are faced with a significant burden of disease requiring long-term treatment. Amgen’s branded biologic medicines and biosimilars are developed and manufactured according to the same high standards, and we are committed to delivering medicines to patients worldwide.”

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases.

Amgen’s MAA submission includes analytical, clinical and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab in both studies. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.

About ABP 501
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).

About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars offer the potential to increase patient access to vital medicines, and Amgen is well positioned to leverage its 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements
This news release contains forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Dec. 3, 2015, and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our ongoing restructuring plan. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or their ability to pay a dividend or repurchase our common stock.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

CONTACT:
Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)

Amgen, Europe
Emma Gilbert, +41 41 369 2542

Friday, December 4th, 2015 Uncategorized Comments Off on (AMGN) First Biosimilar Marketing Authorization Application Submitted to EMA