(DAKP) Update on Pioneer Terminal Expansion and Operations, 2015 Guidance

Tank Storage Expansion Underway on Schedule and Fully Funded New Contracts Increase Throughput to 55,000 Barrels Per Day Beginning in January 2015 Company Provides Full Year 2015 Adjusted EBITDA Guidance of $23.4 million

Dakota Plains Holdings, Inc. (“Dakota Plains” or “the Company”) (NYSE MKT:DAKP) today provided an update on its operations and made several disclosures related to its growth. Highlights are as follows:

• The storage tank expansion project currently underway successfully achieved its winter shut-down point with construction expected to resume in the spring of 2015; the project is on schedule and fully funded. In addition, a new service agreement with an existing client enables increasing the throughput of the Pioneer Terminal to 55,000 barrels per day from January 2015.
• Canadian Pacific has pledged an expanded rail service to underpin the forecast increases in throughput at Pioneer.
• For 2015 the Company provides an annualized guidance that includes an average daily throughput of 57,500 barrels per day and an adjusted EBITDA of $23.4 million.

Craig McKenzie, Chairman and Chief Executive Officer of Dakota Plains, said, “The transaction to buy out our joint venture partner delivers significant value to stockholders as we grow the Pioneer Terminal. The Company is now simpler in its structure and business segments, is stronger in terms of balance sheet and income generation, is no longer exposed to direct commodity pricing risk, and is more flexible than in the past to meet our customers’ needs in logistical services. Based on significant levels of increased interest, we are considering further expansion of the Pioneer Terminal beyond 80,000 barrels per day.”

McKenzie added, “We are encouraged to see significant growth opportunities even during the current low oil price environment. I believe this is a tribute to our competitive advantage as a centrally located, reliable, and cost efficient rail terminal that plays an important role in transporting Bakken and Three Forks oil to market.”

Conference Call

The company will host a conference call on Friday, December 12 at 11:00 am ET to discuss its operational and financial updates with the investment community.

Participants should dial 1-888-256-9132 if calling within the United States or 1-913-312-0653 if calling internationally. A replay will be available until December 19, 2014 and can be accessed by dialing 1-877-870-5176 if calling within the United States or 1-858-384-5517 if calling internationally. Please use passcode 3580581 to access the replay.

In addition, the call will be webcast and will be available on the Company’s website at www.dakotaplains.com or by visiting http://public.viavid.com/index.php?id=112283.

A form 8K has been filed containing a slide presentation that management will reference during the call. The presentation is available on our website at http://dakotaplains.com/investor/presentations/

Adjusted EBITDA

Adjusted EBITDA is a non-GAAP measure. A reconciliation of this measure to its most directly comparable GAAP measure is included in the accompanying financial tables found later in this release. Management believes the use of this non-GAAP financial measure provides useful information to investors to gain an overall understanding of current financial performance. Specifically, management believes the non-GAAP results included herein provide useful information to both management and investors by excluding certain expenses and gains and losses on the extinguishment of debt that management believes are not indicative of Dakota Plains’ core operating results. In addition, this non-GAAP financial measure is used by management for budgeting and forecasting as well as subsequently measuring Dakota Plains’ performance, and management believes it is providing investors with a financial measure that most closely aligns to its internal measurement processes.

About Dakota Plains Holdings, Inc.

Dakota Plains Holdings, Inc. is an integrated midstream energy company operating the Pioneer Terminal transloading facility. The Pioneer Terminal is centrally located in Mountrail County, North Dakota, for Bakken and Three Forks related Energy & Production activity. For more information please visit the corporate website at: www.dakotaplains.com.

Forward Looking Statements

Statements made by representatives of Dakota Plains Holdings, Inc. (“Dakota Plains” or the “Company”) during the course of this press release that are not historical facts, are forward-looking statements. These statements are based on certain assumptions and expectations made by the Company which reflect management’s experience, estimates and perception of historical trends, current conditions, anticipated future developments and other factors believed to be appropriate. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of the Company, which may cause actual results to differ materially from those implied or anticipated in the forward-looking statements. These include risks relating to global economics or politics, our ability to obtain additional capital needed to implement our business plan, minimal operating history, loss of key personnel, lack of business diversification, reliance on strategic, third-party relationships, financial performance and results, prices and demand for oil, our ability to make acquisitions on economically acceptable terms, and other factors described from time to time in the Company’s periodic reports filed with the SEC that could cause actual results to differ materially from those anticipated or implied in the forward-looking statements. Dakota Plains undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information or future events.

(ALXA) Diario Medico Names ADASUVE® in its “Best Ideas of 2014”

MOUNTAIN VIEW, Calif. and BARCELONA, Spain, Dec. 11, 2014  — Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional, S.A. (Ferrer) announced today that the Spanish-based publication Diario Medico included ADASUVE^® (Staccato^® loxapine) in its “Best Ideas of 2014” awards.  The Best Ideas awards by Diario Medico acknowledge the daily work of persons, institutions or enterprises that contributed to the improvement of medicine, healthcare, and public health during the previous year.  Ferrer is Alexza’s commercial partner for ADASUVE in the European Union, Latin America, and the Commonwealth of Independent States countries.

“This award recognizes the innovation that is ADASUVE and its contribution to the improvement in the quality of life of the patients suffering from bipolar disorder and schizophrenia,” said Antoni Villaro, Chief Operating Officer of Ferrer.  “We continue to hear from doctors and nurses who are using ADASUVE that they are impressed with ADASUVE’s strong efficacy and rapid onset as well as its potential to change the practice in treating these patients.”

“The Diario Medico Best Idea award exemplifies the vision of our founder, Dr. Alejandro Zaffaroni.  He believed we could improve patient therapies with our Staccato^® technology, where drugs are quickly vaporized to deliver alternative therapeutic options for a variety of acute and intermittent conditions,” said Thomas B. King, President and Chief Executive Officer of Alexza Pharmaceuticals.  “We believe ADASUVE’s combination of an effective drug in our Staccato system can be a model for changing other suboptimal standard-of-care regimens.  Our primary focus in the near term remains supporting the global commercialization of ADASUVE, and we also look forward to building on the success of this first approved product and developing other product candidates in the coming years.”

About Staccato^®
Staccato technology is a novel form of inhaled drug delivery that is uniquely suited for conditions requiring speed of therapeutic effect, reliable dosing, and ease of use.  Staccato system single-dose device houses a heat package comprising a stainless steel substrate, which is coated with excipient-free drug – the system requires no excipients or pharmaceutical stabilizers.  With a single breath by the patient, the system rapidly actuates to form a drug aerosol of consistent sized particles between one and three microns.  At this size, the particles are rapidly absorbed in the deep lung, ensuring rapid uptake in the bloodstream and rapid onset of pharmacological effect.

About ADASUVE (Staccato loxapine)
ADASUVE combines Alexza’s proprietary Staccato system with loxapine, an antipsychotic medicinal product.  ADASUVE is the first and only inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.  The EU marketing authorization for ADASUVE requires that patients receive regular treatment immediately after administration of the product to control acute agitation symptoms.  It also requires that ADASUVE be administered only in a hospital setting under the supervision of a healthcare professional.  Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side effects, such as bronchospasm.

Alexza and Ferrer estimate that as many as 8 million adults in the EU suffer from schizophrenia or bipolar disorder¹.  Agitation is a common symptom for these patients², characterized by feelings of distress, anxiety, and loss of control.

The authorization for ADASUVE in the EU differs from that in the United States, with respect to the indication statement, dose regimen, available dose strengths, and risk mitigation and management plans.  For more information about ADASUVE, including the Summary of Product Characteristics and Patient Information Leaflet approved in the EU, please visit the EMA website.  For the full prescribing information including boxed warnings for the U.S., please visit www.adasuve.com.

About Ferrer
Founded in 1959, Ferrer is a privately-held European R&D-based pharmaceutical company headquartered in Barcelona.  It is active in the pharmaceutical, health, fine chemicals and food sectors in Europe, Latin America, Africa, the Middle East, Asia and the United States.  In total, Ferrer’s human healthcare products are commercialized in more than 90 countries, through 27 international affiliates (including joint ventures) and 70 partners and distributors.

Ferrer carries out activities throughout the full pharmaceutical value chain, from R&D to international marketing, including fine chemical development and the manufacturing of both raw materials and finished pharmaceuticals.  Its research centers in Spain and Germany, and manufacturing sites in Europe and Latin America cover the pharmaceutical, diagnostics, vaccine, fine chemical, food and feed sectors.  For more information, visit www.ferrer.com.

About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions.  Alexza’s products are based on the Staccato system, a hand-held inhaler designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.

ADASUVE is Alexza’s first commercial product, is based on the Staccato technology, and has been approved for sale by the U.S. Food and Drug Administration, the European Commission, and in several Latin American countries.

Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., is Alexza’s commercial partner for ADASUVE in the U.S.  Ferrer is Alexza’s commercial partner for ADASUVE in Europe, Latin America and the Commonwealth of Independent States countries.  For more information, visit www.alexza.com.

ADASUVE^® and Staccato^® are registered trademarks of Alexza Pharmaceuticals, Inc.

Safe Harbor Statement
This news release contains forward-looking statements that involve significant risks and uncertainties. Any statement describing the Company’s expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs, including the ability of Alexza and its partners, Teva and Ferrer, to effectively and profitably commercialize ADASUVE, estimated product revenues and royalties associated with the sale of ADASUVE, the adequacy of the Company’s capital to support the Company’s operations, and the Company’s ability to raise additional funds and the potential terms of such potential financings. The Company’s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning Alexza’s business are described in additional detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 and the Company’s other Periodic and Current Reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

References:

1.   Wittchen H.U., et al., 2011. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur. Neuropsychopharmacol. 21, 655-679.

2.   Alexza data on file (primary market research among caregivers of patients with schizophrenia (95% have agitation) and bipolar patients (87% have agitation).

(CLIR) Names Stephen E. Pirnat As Chief Executive Officer

SEATTLE, Dec. 11, 2014  — ClearSign Combustion Corporation (NASDAQ: CLIR) (“ClearSign”), an emerging leader in combustion and emissions control technology for industrial, commercial and utility markets, announced today that its Board of Directors has appointed Board member Stephen E. Pirnat as ClearSign’s Chairman and Chief Executive Officer, replacing Richard F. Rutkowski, who resigned his officer and director positions with ClearSign on December 10, 2014. Until Mr. Pirnat assumes office, James N. Harmon, ClearSign’s Chief Financial Officer, will act as interim President (principal executive officer).

Mr. Pirnat, who joined the ClearSign Board of Directors in November of 2011, has extensive experience in the energy supply and services sector, including as the former President and CEO of the John Zink Company, LLC, a subsidiary of Koch Industries and a global leader in the supply of combustion and environmental equipment to the refining, petrochemical, production/exploration and utility industries.

“Steve is a transformational leader with a proven track record of building shareholder value through the development and successful commercialization of innovative products and a focus on operational excellence,” said ClearSign Director, Scott Isaacson. “The board believes he is ideally suited to lead this next phase of ClearSign’s development as ClearSign continues its transition from a development phase into a product and customer focus. Steve’s experience makes him the ideal candidate to lead ClearSign forward.”

At John Zink, Mr. Pirnat oversaw a period of rapid growth both in revenue and profitability, driven by several new product innovations and multiple synergistic acquisitions.

“I am honored to have been asked by the Board to lead ClearSign into the next phase of its growth,” said Pirnat. “The opportunities for ClearSign’s game-changing technologies are immense, and I am very excited to be a part of it.”

Commenting on the transition, Scott Isaacson added, “On behalf of ClearSign and the Board, I want to express our heartfelt gratitude to Rick for his vision. From little more than a revolutionary idea when ClearSign was founded in 2008, through a period of rapid development of both technology and intellectual property, Rick’s efforts have enabled ClearSign to build a foundation upon which to grow.”

Mr. Pirnat was most recently Managing Director of Europe, the Middle East and African operations at Quest Integrity Group, a division of Team Industrial Services, a provider of asset integrity management and asset reliability solutions in the refinery, chemical, petrochemical, pipeline and power industries worldwide. From 2009 to 2011, he was President of Quest Integrated Inc., a technology incubator and boutique private equity firm. From 2000 to 2009, Mr. Pirnat served as President & CEO of the John Zink Company, LLC, a wholly owned subsidiary of Koch Industries and a worldwide leader in the supply of combustion and air pollution control equipment to the energy industry. Mr. Pirnat, a long-time executive with Ingersoll-Rand and Ingersoll-Dresser Corporation, went to John Zink from a previous post as President & CEO of Pangborn Corporation, a leading supplier of surface preparation equipment and associated services to the automotive and aircraft industries. Mr. Pirnat began his career as an applications engineer with the Pump and Condenser Group of Ingersoll-Rand, where he advanced through a variety of sales, marketing, engineering, and operational positions with that company and its successor, Ingersoll-Dresser. These positions included Vice President of Ingersoll-Rand’s Standard Products Division, Vice President of Marketing for Ingersoll-Dresser Pumps, President of Ingersoll-Dresser Pumps Canada Ltd., and Vice President & General Manager of Ingersoll-Rand Engineered Equipment Division. Mr. Pirnat received a BSc. in Mechanical Engineering from the New Jersey Institute of Technology.

Mr. Pirnat will be based at ClearSign headquarters in Seattle.

About ClearSign Combustion Corporation

ClearSign Combustion Corporation designs and develops technologies that aim to improve key performance characteristics of combustion systems including energy efficiency, emissions control, fuel flexibility and overall cost effectiveness. Our Duplex™ Tile and Electrodynamic Combustion Control™ (ECC™) platform technologies improve control of flame shape and heat transfer and optimize the complex chemical reactions that occur during combustion in order to minimize harmful emissions. For more information about ClearSign, please visit www.clearsign.com

Cautionary note on forward-looking statements

This press release includes forward-looking information and statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events that are based on management’s belief, as well as assumptions made by, and information currently available to, management. While we believe that our expectations are based upon reasonable assumptions, there can be no assurances that our goals and strategy will be realized. Numerous factors, including risks and uncertainties, may affect our actual results and may cause results to differ materially from those expressed in forward-looking statements made by us or on our behalf. Some of these factors include the acceptance of existing and future products, the impact of competitive products and pricing, general business and economic conditions, and other factors detailed in our periodic reports filed with the SEC. We specifically disclaim any obligation to update or revise any forward-looking statement whether as a result of new information, future developments or otherwise.

(ABIO) Announces Activation of First Canadian Genetic-AF Clinical Trial Site

ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced the activation of the first GENETIC-AF clinical trial site in Canada. The site activation follows on the August 2014 acceptance by Health Canada of the Company’s Clinical Trial Application (CTA) for the GENETIC-AF clinical trial evaluating Gencaro^TM as a potential treatment for atrial fibrillation (AF). This site brings the total current number of active trial sites to thirty-three. ARCA plans to activate a total of approximately 60 clinical trial sites in the United States and Canada for the Phase 2B portion of the trial.

ARCA is evaluating Gencaro, a pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for AF in the Phase 2B/3 GENETIC-AF clinical trial, which is now enrolling patients in the United States and Canada. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it potential to be the first genetically-targeted therapy for the prevention of atrial fibrillation.

Stuart Connolly, MD, Director of the Division of Cardiology at McMaster University in Hamilton, Ontario, Canada, and Co-Chairman of the GENETIC-AF Steering Committee, commented, “This trial is an innovative pharmacogenetic approach to evaluating the potential efficacy of bucindolol as a treatment for atrial fibrillation. Atrial fibrillation is a growing problem where current medical therapy does not provide adequate treatment, particularly in heart failure populations.”

Jeff Healey, MD and Country Principal Investigator, commented further, “Canadian health care and its clinical trial culture is ideally suited for a trial such as GENETIC-AF, which investigates a potential advance in the unmet need areas of atrial fibrillation prevention and/or rate control in a heart failure population. I hope the Canadian GENETIC-AF trial sites will contribute a substantial number of patients to this program to help advance a potential new treatment for patients at high risk for developing, or living with, atrial fibrillation.”

About Atrial Fibrillation (AF)

Atrial fibrillation, the most common sustained cardiac arrhythmia, is considered an epidemic cardiovascular disease and a major public health burden. The estimated number of individuals with AF globally in 2010 was 33.5 million. According to the 2014 American Heart Association report on Heart Disease and Stroke Statistics, the estimated number of individuals with AF in the U.S. in 2010 ranged from 2.7 million to 6.1 million people. Hospitalization rates for AF increased by 23% among US adults from 2000 to 2010 and hospitalizations account for the majority of the economic cost burden associated with AF.

AF is a disorder in which the normally regular and coordinated contraction pattern of the heart’s two small upper chambers (the atria) becomes irregular and uncoordinated. The irregular contraction pattern associated with AF causes blood to pool in the atria, predisposing the formation of clots potentially resulting in stroke. AF increases the risk of mortality and morbidity due to stroke, congestive heart failure and impaired quality of life. The approved therapies for the treatment or prevention AF have certain disadvantages in patients with heart failure and/or reduced left ventricular ejection fraction (HFREF) patients. These include toxic or cardiovascular adverse effects, and most of the approved drugs for AF are contra indicated or have warnings in their prescribing information for such patients. The Company believes there is an unmet medical need for new AF treatments that have fewer side effects than currently available therapies and are more effective, particularly in HFREF patients.

GENETIC-AF Clinical Trial

GENETIC-AF is a Phase 2B/3, multi-center, randomized, double-blind clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL for prevention of symptomatic AF/atrial flutter in HFREF patients. ARCA plans to enroll only patients with the genetic variant of the beta-1 cardiac receptor which the Company believes responds most favorably to Gencaro. GENETIC-AF has an adaptive design, under which the Company initiated the trial as a Phase 2B trial in approximately 200 patients. The GENETIC-AF Data Safety Monitoring Board (DSMB) will analyze certain data from the Phase 2B portion of the trial and recommend, based on a comparison to the pre-trial statistical assumptions, whether the trial should proceed to Phase 3 and seek to enroll an additional 420 patients.

The AF indication for Gencaro was chosen based on clinical data from the previously conducted Phase 3 heart failure trial of 2,708 patients (the BEST trial). The Company believes data from the BEST trial indicate that Gencaro may have a genetically regulated effect in reducing or preventing AF, whereas the Company believes the therapeutic benefit of Toprol-XL does not appear to be enhanced in patients with this genotype. A retrospective analysis of data from the BEST trial shows that the entire cohort of patients in the BEST trial treated with Gencaro had a 41% reduction in the risk of new onset AF (time-to-event) compared to placebo (p = 0.0004). In the BEST DNA substudy, patients with the beta-1 389 arginine homozygous genotype experienced a 74% (p = 0.0003) reduction in risk of AF when receiving Gencaro, based on the same analysis.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, Gencaro^TM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. For more information please visit www.arcabiopharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding, potential timing for patient enrollment in the GENETIC-AF trial, the sufficiency of the Company’s capital to support its operations, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2013, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

(SPLS) Offers Expanded Me to We Collection

TORONTO, Dec. 10, 2014 – Staples Canada today announced the expansion of the Me to We product line, an assortment of exclusive products that make life-changing impacts in communities overseas, from providing access to education to clean water. Launched earlier this year with back-to-school supplies, the expanded Staples collection features mittens, scarves, toques and travel mugs to keep givers and receivers warm this season.

“Giving a gift always feels great,” said Steve Matyas, president of Staples Canada.  “But giving a gift that benefits others feels even better. Customers love the Me to We collection, and we’re pleased to be able to grow it just in time for the holiday season.”

All products come with a unique eight-digit code for buyers to track exactly where and how their purchase gives a life-changing gift. Customers can visit trackyourimpact.com to learn more about the impact of their particular purchase.

Within just five months of its original launch, the Me to We collection at Staples has already made positive strides in providing essentials for communities around the world. Highlights to date include:

• More than 40,000 pencils
• More than 115,000 lunches
• Some 10,000 trees planted
• Vitamins for more than 1,800 people
• 100 million litres of water

“There’s giving and then there’s giving exponentially,” said Roxanne Joyal, CEO at Me to We. “When you purchase gifts for you and your loved ones, Me to We products enhance the season’s glow while making life-changing impacts in communities overseas—essentially spreading the holiday spirit around the globe.  With the introduction of the Staples Me to We Holiday Collection we’re providing communities around the world with access to education and essential resources that help break the cycle of poverty.”

For information about the Me to We collection at Staples Canada, visit staples.ca/metowe or www.metowe.com.

For a complete list of featured Holiday products and gifts, visit staples.ca/holiday.

About Me to We
Me to We is an innovative social enterprise that offers socially conscious products and services, including socially conscious and environmentally friendly clothes and accessories, as well as life-changing international volunteer trips, leadership training programs and materials, an inspirational speakers bureau, and books which address issues of positive social change. In addition, half of Me to We’s net profit is donated to Free The Children, while the other half is reinvested to grow the enterprise and its social mission. Visit www.metowe.com for more information.

About Staples Canada
Staples makes it easy to make more happen with more products and more ways to shop. Through its world-class retail, online and delivery capabilities, Staples lets customers shop however and whenever they want, whether it’s in-store, online or on mobile devices. Staples offers more products than ever, such as technology, facilities and breakroom supplies, furniture, safety supplies, medical supplies, Copy and Print services and, of course, school supplies. Headquartered outside Boston with Canadian regional offices in Toronto, Laval and Vancouver, Staples operates throughout North and South America, Europe, Asia, Australia and New Zealand. More information about Staples (SPLS) is available at staples.ca.

SOURCE Staples Canada Inc.

Image with caption: “Me to We Mittens. Every Me to We purchase makes a positive impact in a Free The Children community overseas. To see where in the world you made a difference, enter the code found on your product at TrackYourImpact.com (CNW Group/Staples Canada Inc.)”. Image available at: http://photos.newswire.ca/images/download/20141211_C5762_PHOTO_EN_9347.jpg

Media contacts: Jay Reyes, Torchia Communications, 416-341-9929 Ext. 222, jay@torchiacom.com; Alessandra Saccal, Staples Canada, 905-737-1147 Ext.2363, alessandra.saccal@staples.caCopyright CNW Group 2014

(DXM) Organizational Restructuring Yielding up to $150M in Annual Expense Savings

Dex Media, Inc. (NASDAQ:DXM), one of the largest national providers of social, local and mobile marketing solutions to local businesses, today announced sweeping changes designed to reorganize and refocus the company. These changes will result in run-rate annual structural savings estimated between $130 million to $150 million. The savings will ramp up over the first eight months of 2015, with $90 million to $110 million to be realized within the year. One-time cost to achieve is expected to be in the range of $70 million to $100 million, the majority expensed by the end of 2015. Management also expects to identify further expense reductions in 2016 and beyond.

With the cost savings and sales enhancement changes implemented today, the company expects to begin deleveragingwithin 2016.¹ All areas of the company are affected by the changes. Major strategic changes impacting the cost structure include the following:

• Launch of the virtual sales office. Sales reps will be equipped to perform all work with wireless technology, without need for a physical sales office, so they can spend more time with clients. This will enable elimination of all field sales offices.
• Automation of the sales process, enabling a paperless environment where orders will flow through to fulfillment untouched by human hands.
• Integration of systems to eliminate duplication left over since the merger of Dex One and SuperMedia. This will enable streamlining of product portfolios and a material reduction in personnel.
• Variabilizing the print cost structure to enable directory costs to change in lock step with decreases in consumer usage, in addition to the structural cost savings mentioned above.

Today’s changes included planned workforce reductions and job reassignments through 2015 that will impact approximately 1,000 employees or 25% of the company’s employee base, including 350 field sales representatives. The company also de-layered its sales organization by eliminating a layer of management and allowing these experienced sales professionals to return to the field. Additional reductions occurred in the company’s administrative, sales support, field marketing, publishing, distribution, and technology organizations.

In addition to reductions in cost, the company announced a number of revenue enhancement measures. These upgrades include product simplifications enabling a more intuitive client sales call and more satisfying client experience; the introduction of new sales tools, automation of the sales presentation and sales process; enhanced Internet yellow pages (IYP) products that will deliver more intelligent search results and deeper business content, including photos, reviews and videos; as well as improved print yellow pages products resized and reformatted for enhanced readability and reduced paper waste.

“With these changes, we are taking the necessary steps to transform Dex into a leaner, nimbler and more competitive organization,” said Joe Walsh, president and chief executive officer. “Through a combination of cost reductions, product and productivity improvements, we are positioning the company to be the leading digital marketing provider for small and medium-sized businesses.”

The redesign of the company’s search portals, DexKnows.com® and Superpages.com®, will be seen in the first quarter of 2015. Redesigned print directories with attractive new covers and larger interior text will launch in the second quarter of 2015.

¹ On a net debt to adjusted EBITDA basis, before one-time expenses.

About Dex Media

Dex Media (DXM) offers integrated marketing solutions that deliver measurable results. As the marketing department for more than 500,000 small and medium-sized businesses across the U.S., Dex Media helps them Get Found, Get Chosen and Get Talked About. The company’s widely used consumer services include the DexKnows.com® and Superpages.com® search portals and applications as well as local print directories. For more information, visit www.DexMedia.com.

Forward-Looking Statements

Some statements included in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the federal securities laws. Statements that include the words “may,” “will,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “preliminary,” “intend,” “plan,” “project,” “outlook” and similar statements of a future or forward-looking nature identify forward-looking statements. You should not place undue reliance on these statements, as they are not guarantees of future performance. Forward-looking statements address matters that involve risks and uncertainties. Accordingly, there are or will be important factors that could cause our actual results to differ materially from those indicated in these statements, including among others, whether we will be able to implement the corporate restructuring as planned, whether the expected amount of the costs associated with the corporate restructuring will exceed our expectations and whether we will be able to realize the anticipated benefits in the amounts and at the times expected from the corporate restructuring. We believe that these factors include, but are not limited to, the risks related to the following: our inability to provide assurance for the long-term continued viability of our business; failure to comply with the financial covenants and other restrictive covenants in our credit facilities; limitations on our operating and strategic flexibility and the ability to operate our business, finance our capital needs or expand business strategies under the terms of our credit facilities; limited access to capital markets and increased borrowing costs resulting from our leveraged capital structure and debt ratings; changes in our credit rating; changes in our operating performance; reduced advertising spending and increased contract cancellations by our clients, which causes reduced revenue; declining use of print yellow page directories by consumers; our ability to collect trade receivables from clients to whom we extend credit; credit risk associated with our reliance on small and medium sized businesses as clients; our ability to anticipate or respond to changes in technology and user preferences; our ability to maintain agreements with major Internet search and local media companies; competition from other yellow page directory publishers and other traditional and new media including increased competition from existing and emerging digital technologies; changes in the availability and cost of paper and other raw materials used to print our directories; our reliance on third-party providers for printing, publishing and distribution services; our ability to attract and retain qualified key personnel; our ability to maintain good relations with our unionized employees; changes in labor, business, political and economic conditions; changes in governmental regulations and policies and actions of federal, state and local municipalities impacting our businesses; the outcome of pending or future litigation and other claims; the risk that anticipated cost savings, growth opportunities and other financial and operating benefits as a result of the merger of Dex One and SuperMedia may not be realized or may take longer to realize than expected; and other events beyond our control that may result in unexpected adverse operating results.

The foregoing factors should not be construed as exhaustive and should be read together with the other cautionary statements included in the periodic and other reports we file with the Securities and Exchange Commission, including the information in “Item 1A. Risk Factors” in Part I of our Annual Report on Form 10-K for the year ended Dec. 31, 2013. All forward-looking statements included in this release are expressly qualified in their entirety by the foregoing cautionary statements. The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

(RDUS) Presents RAD1901 Data at 2014 San Antonio Breast Cancer Symposium

WALTHAM, Mass., Dec. 11, 2014 — Radius Health, Inc. (Nasdaq:RDUS) announced today that it presented data from a Phase 1 clinical study on estrogen receptor engagement by the investigational drug RAD1901, a tissue-selective estrogen receptor degrader (SERD), in a poster presentation at the 2014 San Antonio Breast Cancer Symposium (SABCS).

Details of the poster presentation at SABCS are as follows:

Title: RAD1901, a novel tissue-selective estrogen receptor degrader (SERD) demonstrates estrogen receptor engagement in a phase 1 clinical study

Session/Poster: Poster Session 3; Poster OT2-1-10

Location: Halls A-B (Henry B. Gonzalez Convention Center)

Date and Time: Thursday December 11, 2014; 5:00 – 7:00 pm CST

Presenter: Gary Hattersley, PhD, Chief Scientific Officer

Despite advances in the treatment of metastatic breast cancer through modulation of estrogen receptor (ER) activity, after initial efficacy, the use of hormonal therapies is frequently followed by the development of de novo or acquired endocrine resistance. Therefore, research is being conducted on possible new agents that might be able to overcome endocrine resistance. One potential mechanism by which this might be achieved is through degradation of the estrogen receptor and thereby elimination of estrogen receptor mediated signaling.

RAD1901 is an investigational, non-steroidal small molecule that is designed to selectively bind and degrade the ER and is currently being evaluated for the potential treatment of metastatic breast cancer. In preclinical models thus far, RAD1901 has shown good tissue selectivity, does not appear to stimulate the uterine endometrium, and appears to protect against bone loss in an ovariectomy-induced osteopenia rat model. In addition, we believe that RAD1901 has the ability to cross the blood-brain barrier. In vitro, treatment of tamoxifen-sensitive and resistant human breast cancer cell lines with the investigational drug RAD1901 resulted in degradation of the ER and inhibition of both basal and estradiol-stimulated proliferation. The poster includes preclinical data indicating that increasing doses of RAD1901 potently induced tumor regression. Tamoxifen and fulvestrant were the comparator drugs in this study.

The poster also includes data from the Phase 1 study where 18F-estradiol positron emission tomography (FES-PET) was used to provide a pharmacodynamic assessment of estrogen receptor engagement/turnover. Following 6-days of daily treatment with the investigational drug RAD1901 at 200mg and 500mg doses, a complete suppression of FES-PET signal was observed, with standardized uptake values (SUV) comparable to background tissues. To date, the maximum tolerated dose of RAD1901 has not been determined.

The potential clinical significance, if any, of the data presented in the poster is currently unknown and must be evaluated further as the development program for the investigational drug RAD1901 continues.

About The Investigational Drug RAD1901

In June 2014, Radius initiated a Phase 1 MTD study in healthy volunteers with the investigational drug RAD1901, a SERD being developed for the potential treatment of metastatic breast cancer, including breast cancer brain metastases (“BCBM”). The study is designed to evaluate the tolerability, safety, and pharmacokinetics of RAD1901, and also to use 18F-fluroestradiol positron emission tomography to provide a pharmacodynamic assessment of estrogen receptor turnover following RAD1901 treatment. Levels of RAD1901 in cerebrospinal fluid samples taken from the study subjects will be measured to confirm that RAD1901 has crossed the blood brain barrier.

Radius is progressing development of the investigational drug RAD1901 for the potential treatment of metastatic breast cancer. Currently, our Phase 1b metastatic breast cancer trial is undergoing institutional review board review and after approval Radius will post the trial on www.clinicaltrials.gov. We are in discussions with the European Organization for the Research and Treatment of Cancer (EORTC) to finalize the protocol design for the initiation of a European Phase1b trial. We anticipate initiation of these trials following regulatory review and upon institutional review board approval.

Radius also is developing the investigational drug RAD1901 for potential use as a selective estrogen receptor modulator, or SERM, for the treatment of vasomotor symptoms. In a Phase 2 proof of concept study, RAD1901 at lower doses demonstrated a reduction in the frequency and severity of moderate and severe hot flashes. We anticipate initiating a Phase2b trial for the treatment of vasomotor symptoms in 2H2015.

About Radius Health

Radius is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers. Radius’ lead development candidate is the investigational drug abaloparatide (BA058) for subcutaneous injection, currently in Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone driven, or hormone resistant, metastatic breast cancer, including breast cancer brain metastases. www.radiuspharm.com

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the potential clinical significance of the data presented in the poster presentation at SABCS, the ability of RAD1901 to cross the blood-brain barrier and the timing of the initiation of clinical trials of RAD1901.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have no product revenues; our need for additional funding, which may not be available; we are not currently profitable and may never become profitable; restrictions imposed on our business by our credit facility, and risks related to default on our obligations under our credit facility; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of abaloparatide-SC, and our inability to ensure that abaloparatide-SC will obtain regulatory approval or be successfully commercialized; risks related to clinical trials, including having most of our products in early stage clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates; product candidates for which we obtain marketing approval, if any, could be subject to restrictions or withdrawal from the market and we may be subject to penalties; failure to achieve market acceptance of our product candidates; risks related to the use of our limited resources on particular product candidates and not others; delays in enrollment of patients in our clinical trials, which could delay or prevent regulatory approvals; the dependence of our drug development program upon third-parties who are outside our control; the risk that a regulatory or government official will determine that third-parties with a financial interest in the outcome of the Phase 3 study of abaloparatide-SC affected the reliability of the data from the study; our reliance on third parties to formulate and manufacture our product candidates; failure to establish additional collaborations; our lack of experience selling, marketing and distributing products and our lack of internal capability to do so; failure to compete successfully against other drug companies; developments by competitors may render our products or technologies obsolete or non-competitive; risks related to the fact that our drugs may sell for inadequate prices or patients may be unable to obtain adequate reimbursement; effects of product liability lawsuits on commercialization of our products; failure to comply with obligations of our intellectual property licenses; failure to protect our intellectual property or failure to secure necessary intellectual property related to abaloparatide-SC, abaloparatide-TD, RAD-1901 and/or RAD-140; our or our licensors’ inability to obtain and maintain patent protection for technology and products; risks related to our compliance with patent application requirements; failure to protect the confidentiality of our trade secrets; risks related to our infringement of third parties’ rights; risks related to employees’ disclosure of former employers’ trade secrets; risks associated with intellectual property litigation, including expending substantial resources and distracting personnel from their normal responsibilities; risks associated with healthcare reform; our failure to comply with healthcare laws and regulations; our exposure to claims associated with the use of hazardous materials and chemicals; inability to successfully manage our growth; risks relating to business combinations and acquisitions; our reliance on key executive officers and advisors; our inability to hire additional qualified personnel; volatility in the price of our common stock; capital appreciation is the only source of gain for our common stock; risks related to increased costs and compliance initiatives associated with operating as a public company; our directors, executive officers and principal stockholders have substantial control over us and could delay or prevent a change in control; future sales of our common stock could depress the price of our common stock; inaccurate or unfavorable information about us could cause the price of our common stock to decline; provisions in our charter documents and Delaware law could discourage takeover attempts; and our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 10, 2014, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

CONTACT: Investor Relations
         Barbara Ryan
         FTI Consulting
         Managing Director
         212-850-5679
         Barbara.Ryan@fticonsulting.com

         Media Relations
         Kimberly Ha
         FTI Consulting
         Senior Director
         212-850-5612
         Kimberly.Ha@fticonsulting.com

(NVEE) Awarded $2 Million Contract by San Diego County Regional Airport Authority

(CYRN) & Bangcle to Power Threat Detection for 500 Million Mobile Phone Users

World’s Largest Mobile Application Security Provider to Deploy CYREN Security Technology

MCLEAN, Va., Dec. 10, 2014  — CYREN (NASDAQ: CYRN) and China-based Bangcle, the world’s largest mobile application security provider, today announced that Bangcle will deploy CYREN’s embedded technology to protect mobile applications against today’s latest threats.

Bangcle helps developers guard their apps against malicious code, tampering and pirating while also protecting private customer account information. By the end of November, 400,000 mobile applications have adopted the Bangcle security app shield, which covers 500 million mobile phones globally.

Bangcle’s users will benefit from CYREN Embedded Antivirus as well as CYREN Mobile Security for Android, which delivers the most reliable and proven tool available today to combat increasing malware and other web-borne threats – creating a clear differentiator to help further bolster revenues.

Offering a completely seamless experience, CYREN arms Bangcle customers with a mobile security solution featuring one of the lowest software footprints in the industry. With a modular design for mobile environments, CYREN’s easily integrated technology provides industry-leading performance through ultra-low processing bandwidth consumption, low memory usage, and low storage requirements.

“We chose CYREN’s antivirus technology because our evaluation proved it offered an impressively high detection rate while consuming very little bandwidth,” said Tom Kan, CEO at Bangcle. “Additionally, CYREN offered superior technical support and a level of customer service that not only provides peace of mind for our teams, but those of our users as well.”

“The partnership with Bangcle is one of our latest in Asia – a region that continues to provide a significant number of growth opportunities for CYREN’s embedded business,” said Lior Samuelson, CEO and Chairman of the Board at CYREN. “Bangcle’s selection of CYREN technology underscores our level of commitment to our global network of partners.”

About Bangcle
Bangcle is the world’s largest mobile application security provider. Through its leading technology, Bangcle is committed to providing reliable products and services, and establishing the safe mobile application ecosystem for government, enterprise, developers and consumers. For more information on Bangcle, visit www.secneo.com.

About CYREN
CYREN is a leading provider of cloud-based cybersecurity solutions that deliver powerful protection through global data intelligence. Regardless of the device or its location, CYREN’s easily deployed web, email, and anti-malware products deliver uncompromising protection in both embedded and Security as a Service (SecaaS) deployments. Organizations rely on CYREN’s cloud-based threat detection and proactive security analytics to provide up-to-date spam classifications, URL categorization and malware detection services. The CYREN GlobalView Cloud Platform leverages Recurrent Pattern Detection™ technologies to protect more than 550 million users in 190 countries. CYREN is traded on the NASDAQ Capital Market and the Tel Aviv Stock Exchange (TASE) under the trading symbol “CYRN.” Visit the CYREN GlobalView Security Center or go to www.CYREN.com.

Blog: blog.cyren.com
Facebook: www.facebook.com/CyrenWeb
LinkedIn: www.linkedin.com/company/cyren
Twitter: twitter.com/CyrenInc

© 2014 CYREN Ltd. CYREN and GlobalView are trademarks of CYREN Ltd. Other company and product names may be trademarks of their respective owners.

U.S. Investor Contact:
Garth Russell
KCSA
212.896.1250
grussell@kcsa.com

Israel Investor Relations Contact:
Iris Lubitch
EffectiveIR
+972.54.2528007
iris@FinCom.co.il

CYREN Company Contact:
Mike Myshrall, CFO
CYREN
703.760.3320
mike.myshrall@cyren.com

CYREN Media Contact:
Matthew Zintel
Zintel Public Relations
281.444.1590
matthew.zintel@zintelpr.com

Bangcle Company Contact:
Odin Liu, VP
+86 1062660308
Odin.liu@bangcle.com

Bangcle Media Contact:
Jia Zhao
+086 1062660308
Jia.zhao@bangcle.com

(AKER) Announces $1 Million Initial Order to Supply PIFA Heparin/PF4 Products to China

THOROFARE, N.J., Dec. 10, 2014  — Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), (the “Company”), a leading designer and manufacturer of rapid diagnostic screening and testing products, announces the receipt of an initial purchase order (the “Order”) valued at US$1,000,000 from NovoTek Therapeutics Inc. (“NovoTek”) to supply PIFA Heparin PF4/Rapid Assay products in Mainland China (“China”).

NovoTek, a Beijing‐based pharmaceutical and medical device business development company, holds the exclusive sales and marketing rights for the Company’s PIFA Heparin/PF4 Rapid Assay products in China. The Company expects to deliver the Order by December 31, 2014.

PIFA Heparin/PF4 Rapid Assay and PIFA PLUSS PF4 remain the only US FDA-cleared rapid manual assays that quickly determine if a patient being treated with the blood thinner heparin may be developing a drug allergy. This clinical syndrome known as heparin‐induced thrombocytopenia (“HIT”) reverses the heparin’s intended therapeutic effect and transforms it into a clotting agent. Patients suffering HIT are at risk of developing limb- and life-threatening complications, so the timely test result provided by the Company’s Heparin/PF4 devices is paramount to effective, clinical decision making. In the U.S. alone, approximately 12 million patients are exposed to heparin annually and 1% to 5% of those patients receive a HIT diagnosis. The largest at-risk populations are patients undergoing major cardiac or orthopedic surgical procedures.

“We believe China can be a very significant market for the Company’s PIFA Heparin/PF4 Rapid Assay products,” said Raymond F. Akers, Jr. PhD, Co-founder and Executive Chairman of the Board. “Unlike in the U.S. where we are seeking to disrupt a pre-existing, slow, expensive, laboratory-based testing method for heparin platelet factor 4 antibodies, there is, as far as we are aware, no competing test in China,” continued Dr. Akers. “We have been working with NovoTek for two years to advance the regulatory approval process required to launch these tests into China. We are delighted that Akers’ tests will be the first approved diagnostic assay in China to assist in the diagnosis of the allergy to the widely used blood-thinner, heparin.”

“China’s healthcare system is improving and the need for reliable and timely diagnosis is becoming increasingly recognized,” continued Dr. Akers. “With China’s economy growing, we believe it to be the second biggest potential market in the world for our PIFA Heparin/PF4 Rapid Assay products. With no competing test of which are aware, Akers is poised to establish its products as the gold standard,” said Dr. Akers.

ABOUT AKERS BIOSCIENCES, INC.

Akers Biosciences develops, manufactures, and supplies rapid, point of care screening and testing products designed to bring healthcare information both rapidly and directly to the consumer or healthcare provider. The Company has advanced the science of diagnostics while responding to major shifts in healthcare through the development of several proprietary platform technologies. The Company’s state-of-the-art rapid diagnostic assays can be performed virtually anywhere in minutes when time is of the essence. The Company has aligned with major healthcare companies and high volume medical products distributors to maximize product offerings, and to be a major worldwide competitor in diagnostics.

Additional information on the Company and its products can be found on our website at www.akersbiosciences.com. Follow us on Twitter @AkersBio.

ABOUT NOVOTEK THERAPEUTICS INC.

NovoTek Therapeutics Inc. is a vital part of NovoTek Group, and is in charge of all international business. To date, NovoTek Group has grown to seven subsidiary companies focused on pharmaceutical marketing, medical and IVD products marketing, and contract research services. NovoTek has its own preclinical research facility, clinical trial and regulatory teams, and more than 600 sales representatives (500 for pharmaceuticals and 100 for medical devices) across China. NovoTek has more than 800 employees and more than 10 local branches nationwide. www.novotekchina.com

Cautionary Statement Regarding Forward Looking Statements

Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to Akers Biosciences, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.

CONTACT: For more information:
         Akers Biosciences, Inc.
         Raymond F. Akers, Jr. PhD
         Executive Chairman of the Board
         Tel. +1 856 848 8698

         RedChip Companies, Inc. (US Investor Relations)
         Jon Cunningham
         Tel. +1 407 644 4256 x107

         finnCap (UK Nominated Adviser and Broker)
         Geoff Nash / Scott Mathieson (Corporate Finance)
         Steve Norcross (Broking)
         Tel: +44 (0)20 7220 0500

         Vigo Communications (UK Investor Relations)
         Ben Simons / Alexandra Roper
         Tel. +44 (0)20 7016 9570
         akers@vigocomms.com

(SOFO) and Lanyon to Present Live Webinar: The Attendee Journey

Mediasite Events by Sonic Foundry, Inc. (NASDAQ: SOFO), the trusted leader for video creation and management solutions, is partnering with Lanyon to present a live webinar, “The Attendee Journey: Leveraging Technology Before, During and After Your Event.”

Register for the free, Dec. 16 webinar at www.sonicfoundry.com/LanyonWebinar.

Lanyon is the leader in providing cloud-based software for meetings, events and travel programs that enables event and marketing professionals to create and manage smarter meetings and events. Lanyon pairs Sonic Foundry’s Mediasite Events webcasting services, which deliver live and on-demand streaming to remote audiences on any device, with its conference management solutions. This enables Lanyon’s customers to deliver a seamless, engaged experience for attendees in-person and online.

The live webinar via Mediasite, presented by Kevin Iwamoto, VP of Industry Strategy at Lanyon, and Donny Neufuss of Mediasite Events, will discuss the latest trends in event design and meeting technology.

Since the spring of 2013, Lanyon captured for its customers more than 2,700 presentations via Mediasite that garnered over 28,000 viewers. That’s more than 5,600 hours of content that is now available on-demand.

“Data shows event attendees are expecting more and more from their event technology. During our webinar, we’ll share what meeting planners should be looking for and why partnering with premier solutions like Mediasite Events can make all the difference in executing a successful event,” Iwamoto said.

Mediasite Events is a leading global provider of live and on-demand webcasting for hybrid events and high-profile meetings, supplying turnkey streaming solutions for about 700 events annually. The group works with Fortune 500 corporations, university associations, sporting events and charitable organizations to produce successful, high-quality online experiences that score rave reviews and achieve event goals.

About Lanyon

Lanyon is the leading provider of cloud-based software for managing corporate meetings, events, and travel programs. From a one-to-one sales meeting, employee training or a large flagship customer conference, Lanyon’s unmatched software and the data it provides helps thousands of organizations and hotels around the world to better engage their customers, reduce costs and grow revenue. Visit www.lanyon.com for more details.

About Sonic Foundry®, Inc.

Sonic Foundry (NASDAQ: SOFO) is the trusted leader for video capture, management and webcasting solutions in education, business and government. The patented Mediasite Enterprise Video Platform transforms communications, training, education and events for more than 3,000 customers in over 60 countries. The company empowers organizations to reach everyone through the power of video; accelerating knowledge-sharing, preserving valuable content, building stronger teams and getting results.

© 2014 Sonic Foundry, Inc. Product and service names mentioned herein are the trademarks of Sonic Foundry, Inc. or their respective owners.

Sonic Foundry, Inc.
Press Contacts:
Tammy Jackson
608.770.9052
tammy@sonicfoundry.com
or
Nicole Wise
608.237.8678
nicolew@sonicfoundry.com

(ABIO) Announces Management Transitions

ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced three management team transitions.

Patrick Wheeler, ARCA’s Chief Financial Officer, has notified ARCA of his intent to leave the company in order to pursue other career opportunities after having served ARCA for 9 years. He will remain with the company through December 31, 2014 to assist in the transition of his responsibilities. Mr. Wheeler joined the company in 2006 and has held financial and senior management positions of increasing responsibility throughout his tenure.

Brian Selby has been promoted to Vice President, Finance and Chief Accounting Officer. He will report to the CEO and be responsible for ARCA’s internal and external financial reporting, including compliance with the rules and regulations of the U.S. Securities and Exchange Commission, and corporate financing activities. Mr. Selby has been the company’s Controller for 7 years and has extensive experience in corporate accounting and finance. Prior to joining ARCA, he worked at several public companies, including Controller for Myogen, Inc. and Controller for Genomica Corporation.

Thomas Keuer has been promoted to Chief Operating Officer. He will report to the CEO and be responsible for pharmaceutical operations, human resources, facilities, and information technology. Mr. Keuer has been the Company’s Executive Vice President, Pharmaceutical Operations for the past 8 years. Prior to joining ARCA, he served in a number of senior leadership positions in the biopharmaceutical industry including SVP of Operations for Insmed, Inc., VP of Engineering for Baxter Healthcare, and VP of Operations for Somatogen, Inc.

“Pat has been a tremendous asset to the Company over the past 9 years, helping shape our strategy, financing and development,” said Michael R. Bristow, President and CEO for ARCA. “We are grateful for his service and contributions and wish him well in all his future endeavors. I am very pleased with the abilities of our people with such longevity within the company to continue the leadership of the organization. I look forward to continuing working with Tom and Brian in their expanded roles. Their industry and professional experience will be valuable as ARCA continues the development of Gencaro as a potential treatment for atrial fibrillation.”

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, Gencaro^TM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. For more information, please visit www.arcabiopharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2013, and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

(CALA) Presents Novel Pharmacodynamic Assay Data On Glutaminase Inhibition in Tumor

SOUTH SAN FRANCISCO, Calif., Dec. 10, 2014  — Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer agents, today announced results of studies with primary human breast tumors that support glutaminase as a potential target in triple negative breast cancer (TNBC). Using a novel pharmacodynamic assay designed to measure the extent of glutaminase inhibition in a single post-dose tumor biopsy sample, significant glutaminase inhibition was observed following oral administration of CB-839. These data were presented during the San Antonio Breast Cancer Symposium in San Antonio, Texas. Calithera is developing CB-839, a potent, selective and orally bioavailable glutaminase inhibitor that is currently in Phase I clinical trials in solid and hematological malignancies.

“Our development of a novel pharmacological assay allows us to directly assess glutaminase inhibition in patients receiving CB-839 from just a single post-dose tumor biopsy, allowing us to get confirmation that CB-839 is reaching the tumor and inhibiting the target,” said Susan Molineaux, Ph.D., President and Chief Executive Officer of Calithera.

The data were presented in a poster titled, “A Novel Pharmacodynamic Assay to Measure Glutaminase Inhibition Following Oral Administration of CB-839 in Triple Negative Breast Cancer Biopsies,” on December 10, 2014 (Abstract #P1-08-07). Potent glutaminase inhibition by CB-839 was demonstrated in primary TNBC tumor lysates as well as in tumors from a TNBC xenograft model. In addition, glutaminase inhibition of 75-84% was observed in tumor biopsy samples from three solid tumor patients enrolled in early dose cohorts of the ongoing phase I clinical trial.

Additional data showed that glutaminase mRNA expression, protein expression, and enzyme activity are all elevated in human TNBC tumors when compared to ER+ breast cancer tumors, or normal breast tissue. In breast cancer cell lines, expression of glutaminase is a biomarker that predicts sensitivity to CB-839.

Two posters will be presented by Calithera’s collaborators. Details for the presentations are as follows:

About Calithera Biosciences

Calithera Biosciences is a clinical-stage company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology. Calithera’s lead clinical candidate, CB-839, is a first-in-class inhibitor of glutaminase, a critical enzyme in tumor metabolism, and is currently being tested in patients with solid and hematological cancers. Calithera Biosciences is headquartered in South San Francisco. For more information about Calithera Biosciences, please visit www.calithera.com.

Forward-Looking Statements

This news release contains forward-looking statements by Calithera that involve risks and uncertainties. Actual results may differ from Calithera’s expectations and important factors that could cause actual results to differ materially. Calithera’s product candidates may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, future clinical trials may not show significant glutaminase inhibition following oral administration of CB-839. Furthermore, Calithera’s product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s Quarterly Report on Form 10-Q for the period ended September 30, 2014 and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

CONTACT: Jennifer McNealey
         ir@Calithera.com
         650-870-1071

(MDWD) to Present at Oppenheimer 25th Annual Healthcare Conference

MediWound Ltd. (Nasdaq:MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that Company management will participate at the Oppenheimer 25^th Annual Healthcare Conference taking place from December 10-11, 2014 in New York City. Gal Cohen, President and Chief Executive Officer of MediWound, will be presenting a corporate overview on Thursday, December 11^th at 3:20 p.m. Eastern time.

Mr. Cohen’s presentation will broadcast live and can be accessed by visiting the investors section of the company’s website at www.mediwound.com. A replay of the webcast will be archived on the MediWound website for 90 days following the presentation.

About MediWound Ltd.

MediWound is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, as well as chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency for removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns and has been launched in Europe. NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues. For more information, please visit www.mediwound.com.

(ATNM) Scientific Board Endorses, Supports Iomab-B Phase 3 Clinical Trial Dev Program

Experts in Leukemia and Bone Marrow Transplant Prepare for Upcoming Pivotal Trial of Actinium’s Iomab-B With the Potential to Change the Way Relapsed and Refractory Acute Myeloid Leukemia (AML) in Older Patients Is Treated

(EXXI) to Present at CapitalOne 2014 Securities Energy Conference

HOUSTON, Dec. 9, 2014  — Energy XXI (Nasdaq:EXXI) (AIM:EXXI) today announced Chairman, President and Chief Executive Officer John Schiller will present at the CapitalOne 2014 Securities Energy Conference in New Orleans on Thursday, Dec. 11, 2014 at 1:40 p.m. Central Time.

Information regarding webcasting will be available on the Energy XXI homepage (www.EnergyXXI.com) in the Investor Relations, Events & Presentations section.

About the Company

Energy XXI is an independent oil and natural gas exploration and production company whose growth strategy emphasizes acquisitions, enhanced by its value-added organic drilling program. The company’s properties are located in the U.S. Gulf of Mexico waters and the Gulf Coast onshore.  Cantor Fitzgerald Europe is Energy XXI’s listing broker in the United Kingdom.  To learn more, visit the Energy XXI website at www.EnergyXXI.com.

CONTACT: ENQUIRIES OF THE COMPANY

         Energy XXI
         Greg Smith
         Vice President, Investor Relations
         713-351-3149
         gsmith@energyxxi.com

         Cantor Fitzgerald Europe
         Nominated Adviser: David Porter, Rick Thompson
         Corporate Broking: Richard Redmayne
         Tel: +44 (0) 20 7894 7000

         Pelham Bell Pottinger
         James Henderson
         jhenderson@pelhambellpottinger.co.uk
         Mark Antelme
         mantelme@pelhambellpottinger.co.uk
         +44 (0) 20 7861 3232

(CGIX) to Receive $530,000 Through New Jersey Technology Business Tax Program

RUTHERFORD, N.J., Dec. 9, 2014  — Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “the Company”), an emerging leader in DNA-based cancer diagnostics, announced today that it has received preliminary approval for a $570,000 tax credit from the New Jersey Technology Business Tax Certificate Transfer Program for the year 2014. The company anticipates that it will be able to transfer this credit and receive approximately $530,000 in cash in mid-December.

The program, which is sponsored by the New Jersey Economic Development Authority (EDA), provides up to $60 million each year to eligible New Jersey-based technology and biotechnology companies to support job creation and innovation.

“We want to thank NJEDA for recognizing us once again as a promising and innovative company,” stated Panna Sharma, CEO of Cancer Genetics, Inc. “Receiving $530,000 in non-dilutive financing is a welcome boost to our healthy balance sheet. We are proud to be part of the NJ biotechnology community and appreciate the state’s strong support of growth industries that are essential for job growth and innovation.”

About Cancer Genetics

Cancer Genetics Inc. is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference labs are focused entirely on maintaining clinical excellence and are both CLIA certified and CAP accredited and have licensure from several states including New York State. We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute.

For more information, please visit or follow us:

Internet: http://www.cancergenetics.com

Twitter: @Cancer_Genetics

Facebook: www.facebook.com/CancerGenetics

Forward Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential opportunities for Cancer Genetics, Inc. products and services, 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, risks of cancellation of customer contracts or discontinuance of trials, risks that the transaction will not close or, if it closes, will not realize the currently anticipated benefits, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Company’s Form 10-K for the year ended December 31, 2013 and 10-Q for the quarter ended September 30, 2014 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics disclaims any obligation to update these forward-looking statements.

CONTACT: Media Relations
         Paul Kuntz
         RedChip Companies, Inc.
         800-733-2447, ext. 105
         paul@redchip.com

         Investor Relations
         Michael Rice
         LifeSci Advisors, LLC
         646-597-6997

(NRCIB) New Solution Enables Healthcare Organizations to Publish Physician Reviews Online

National Research Corporation acquires Digital Assent to launch solution that gives healthcare organizations control over online physician reputation

LINCOLN, NEB., Dec. 9, 2014  — National Research Corporation announced today the acquisition of Digital Assent and launch of its Reputation solution, which enables healthcare organizations to collect, display, and syndicate authentic patient ratings and reviews across owned and affiliated websites.

Atlanta-based Digital Assent developed the provider-focused online review system. Andrew Ibbotson, founder and CEO of Digital Assent, shared his optimism about the Reputation solution’s future.

“National Research is a trusted source of healthcare consumer data and thought leadership in the minds of hospital marketers and health system leaders. Because of their comprehensive portfolio of consumer-focused solutions, we knew National Research would be the best partner to guide and support future development of this solution,” Ibbotson said.

The National Research Reputation solution is powered by patient experience data collected from any survey vendor. Publishing doctor ratings and patient comments online increases search traffic and promotes consumer choice of a healthcare organization. The solution provides a more accurate picture of a physician’s reputation, with a larger sample size and more positive feedback than can be found on third-party physician rating websites.

Steve Jackson, Group President for National Research said, “The National Research Reputation solution is a powerful tool for healthcare organizations seeking to manage physician reputation, optimize marketing spend, and embrace transparency. We’re excited about how quickly and easily clients can implement the solution and realize a return on investment.”

To learn more, visit www.nationalresearch.com/reputation or see us at the Institute for Healthcare Improvement (IHI) conference, Booth #704 on December 7 – 10 in Orlando, Florida.

About National Research Corporation

For more than 30 years, National Research Corporation (NASDAQ: NRCIA and NRCIB) has been at the forefront of patient-centered care. Today the company’s focus on empowering customer-centric healthcare across the continuum extends patient-centered care to incorporate families, communities, employees, senior housing residents, and other stakeholders.

National Research is dedicated to representing the true voice of patients and other healthcare stakeholders. This integration of cross-continuum metrics and analytics uncovers insights for effective performance improvement, quality measurement, care transitions, and many other factors that impact population health management.

For more information, call 800-388-4264, write to info@nationalresearch.com, or visit www.nationalresearch.com.

CONTACT: Kayla Lounsbery 
         Marketing Manager
         National Research Corporation
         800-388-4264
         klounsbery@nationalresearch.com

(MZOR) Receives Purchase Orders for Three Renaissance® Systems in Asia

Mazor Robotics Ltd. (NASDAQGM: MZOR) (TASE: MZOR), a developer of innovative guidance systems and complementary products, today announced that it received a purchase order for two Renaissance systems from its distribution partner in China, Cicel (Beijing) Science & Technology CO. Ltd., reflecting the first systems sold into the Chinese market following the receipt of the China Food and Drug Administration (CFDA) approval to market the Renaissance system in China, in September 2014.

The Company also received a purchase order for one Renaissance system from its distribution partner in Taiwan, Pinnaclemed CO. Ltd. Subject to certain closing conditions, the system is expected to be installed at a newly opened spine hospital in Taiwan. This is the third system purchase by Pinnaclemed Co. Ltd. and will be the third Renaissance system in Taiwan.

“Entering the Chinese market is a significant achievement for Mazor and expands our growing presence in the fastest growth region for Renaissance outside of the U.S. market. We look forward to working closely with our distribution partner to raise the awareness of Renaissance throughout the country highlighting the benefits of the system to leading healthcare facilities. An order for a third system in Taiwan is encouraging as the two systems currently in use have some of the highest utilization rates demonstrating the degree of surgeon comfort, system performance and patient outcome,” commented Ori Hadomi, Mazor’s Chief Executive Officer.

Today’s announcement was made in accordance with Mazor Robotics’ disclosure policy of announcing system sales that have a strategic impact on the business, such as new markets, academic institutions and national accounts.

About Mazor

Mazor Robotics is dedicated to the development and marketing of innovative surgical guidance systems and complementary products that provide a safer surgical environment for patients, surgeons, and operating room staff. Mazor Robotics’ flagship product, Renaissance®, is a state-of-the-art surgical guidance system that enables surgeons to conduct spine surgeries in an accurate and secure manner. Mazor Robotics systems have been successfully used in the placement of over 60,000 implants worldwide. Numerous peer-reviewed publications and presentations at leading scientific conferences have validated the accuracy, usability, and clinical advantages of Mazor Robotics technology. For more information, the content of which is not part of this press release, please visit www.mazorrobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the installment of Renaissance at a leading hospital in Taiwan,. raising the awareness of the Renaissance throughout China, the benefits of Renaissance, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F issued to the SEC on April 9, 2014 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings and the amendments thereto. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

U.S. Contacts: EVC Group
Michael Polyviou, 212-850-6020 (Investors)
mpolyviou@evcgroup.com
Robert Jones, 646-201-5447 (Investors)
bjones@evcgroup.com
David Schemelia, 646-201-5431 (Media)
dave@evcgroup.com

(BLRX) Reports Positive Data from Ongoing Phase 2a Study for AML Treatment at ASH Conference

– Data show six-fold increase in mobilization of AML cells from bone marrow; Treatment with BL-8040 as single agent led to 70% decrease in AML cells in bone marrow and 3.5-fold increase in AML cell apoptosis –

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that data from the on-going Phase 2a clinical trial of BL-8040 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) were reported at the American Society of Hematology (ASH) meeting, held on December 6-9, 2014, in San Francisco.

Results reported to date in the dose-escalation stage of the Phase 2a study show that, even at the highest dose reached to date (1.25 mg/kg), there were no dose-limiting toxicity events or serious adverse events, nor early discontinuations attributable to BL-8040. Furthermore, BL-8040 triggered substantial mobilization of AML cancer cells from the bone marrow to the peripheral blood, with a median 6-fold increase of AML cells in the blood. This mobilization is crucial for exposing a higher ratio of AML cells to accompanying chemotherapy such as Ara-C. Additional results show that after only two days of BL-8040 monotherapy, there was a median decrease of approximately 70% in the amount of AML cells in the bone marrow, while the levels of normal progenitor cells remained stable. Furthermore, BL-8040 as a monotherapy showed a 3.5-fold increase in cell death (apoptosis) of AML cells, both in the bone marrow and in peripheral blood samples.

Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx, stated, “We are very encouraged by the data that we see at this stage of the Phase 2a study for BL-8040, which show substantial mobilization and robust apoptosis, and we hope that we will continue to see a dose response as we test higher doses. The dose escalation stage, which is currently ongoing, is expected to be completed early next year. In addition, we recently added the Mayo Clinic as our fourth world-class site in the U.S., and we plan to open up several additional sites in the U.S. in the next few months. We look forward to reporting results of the escalation stage, and initiating the expansion phase of the trial, in which the optimal dose of BL-8040 will be further assessed for safety as well as efficacy. The full study is expected to be completed in the second half of 2015.”

BioLineRx will host a breakfast for investors and analysts in New York on December 12th to present its 2015 clinical development plan for BL-8040, including the initiation of clinical studies in three new indications. Dr. Jorge Cortes, Distinguished Professor of Leukemia Research at the MD Anderson Cancer Center in Houston, Texas, will deliver the keynote presentation, “Current Developments in the AML Treatment Space.” The event will be webcast and presentation materials will be available on the BioLineRx website.

About BL-8040’s Phase 2 Trial

The Phase 2 trial is a multicenter, open-label study under an IND, conducted at nine clinical sites in the U.S. and Israel, and is designed to evaluate the safety and efficacy of repeated doses of BL-8040 in adult patients with relapsed or refractory AML. The primary endpoints of the study are the safety and tolerability of BL-8040. Secondary endpoints include the pharmacokinetic profile of the drug and an efficacy evaluation, indicated by the extent of mobilization of cancer cells from the bone marrow to the peripheral blood, the level of cancer cell death (apoptosis) and clinical responses.

The study is comprised of two parts – the current dose escalation stage and a subsequent expansion stage at the optimal dose determined during the escalation stage. During the dose escalation stage, trial participants are generally recruited in cohorts of three patients at a time, and the dose is increased for each subsequent cohort depending on the safety and tolerability results of the previous cohort, as confirmed by an independent Data Safety Monitoring Board. To date, there have been no serious adverse events related to BL-8040 up to and including the fourth dosing level in the study of 1.25 mg/kg, with the primary adverse event being a transient reaction at the injection site. The study is currently in the fifth and final dosing level originally planned in the study of 1.5 mg/kg. Due to the fact that BL-8040 was found safe at all doses tested to date, and based on the recommendation of the CAB, the Company intends to add additional cohorts to the current dose escalation stage of the study, in order to determine the optimal dose for the remainder of the study.

About BL-8040

BL-8040 is a clinical-stage drug candidate for the treatment of acute myeloid leukemia, as well as other hematological indications. It is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis (growth of new blood vessels in the tumor), metastasis (spread of the disease to other organs or organ parts) and cell survival. CXCR4 is over expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a Phase 1/2, open-label, dose escalation, safety and efficacy clinical trial in 18 multiple myeloma patients, BL-8040 demonstrated an excellent safety profile at all doses tested and was highly effective in the mobilization of hematopoietic stem cells and white blood cells from the bone marrow to the peripheral blood.

BL-8040 also mobilizes cancer cells from the bone marrow and may therefore sensitize these cells to chemo- and bio-based anti-cancer therapy. Importantly, BL-8040 has also demonstrated a direct anti-cancer effect by inducing apoptosis. Pre-clinical studies show that BL-8040 is efficient, both alone and in combination with the anti-cancer drug Rituximab, in reducing bone marrow metastasis of lymphoma cells and stimulating lymphoma cell death. In addition, the current Phase 2 clinical trial in AML patients has demonstrated robust mobilization and apoptosis of cancer cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

About Acute Myeloid Leukemia (AML)

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common type of acute leukemia in adults. According to the American Cancer Society, approximately 14,500 new cases of AML were diagnosed in the United States in 2013, and the median age of AML patients was 66 years old. The frontline treatment for patients with AML includes systemic combination induction chemotherapy. The median survival for patients receiving induction chemotherapy, which is associated with high mortality, is 6-12 months, with shorter survival for patients over the age of 60 or for those with certain gene or chromosome aberrations. The five-year survival rate for AML is 10-30 percent, due to relapsed or refractory disease associated with standard treatments.

About BioLineRx

BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx’s current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a pivotal CE-Mark registration trial scheduled for completion in mid-2015; BL-8040, a cancer therapy platform, which is in the midst of a Phase 2 study for acute myeloid leukemia (AML) as well as a Phase 1 study for stem cell mobilization; and BL-7010 for celiac disease, which has successfully completed a Phase 1/2 study.

For more information on BioLineRx, please visit www.biolinerx.com or download the investor relations mobile device app, which allows users access to the Company’s SEC documents, press releases, and events. BioLineRx’s IR app is available on the iTunes App Store as well as the Google Play Store.

Various statements in this release concerning BioLineRx’s future expectations, including specifically those related to the development and commercialization of BL-8040, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “may,” “expects,” “anticipates,” “believes,” and “intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 17, 2014. In addition, any forward-looking statements represent BioLineRx’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

(INNL) Appoints Tony Zook CEO, Progresses Toward Becoming Commercially Fully-Integrated

Michael Myers Appointed as Head of Portfolio Operations to Continue Guiding Late-Stage Clinical Programs

ATHLONE, Ireland, Dec. 8, 2014  — Innocoll AG (Nasdaq:INNL) today announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca, has been appointed chief executive officer effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations. The executive changes were made to better position the company as its pipeline advances to late-stage clinical development and Innocoll prepares to become a fully-integrated specialty pharmaceutical company.

“Having the right people in executive positions has been an important topic during board meetings, especially due to the rapid progress at the company,” said Jonathan Symonds, chairman of the Board of Directors. “Michael and his team are to be commended for successfully advancing our pipeline. As we looked forward, the Board and the current management team planned to appoint an experienced senior pharmaceutical executive as CEO to manage the company’s evolution to a commercial-stage company. I worked with Tony during his time at AstraZeneca and he is a highly experienced and accomplished pharmaceutical executive with proven ability to manage both commercial and development organizations and successfully develop and launch innovative new medicines. As we were rapidly approaching the point where we will have multiple late stage opportunities in our pipeline, we believed we needed to move quickly with this exciting appointment.”

Michael Myers, Head of Portfolio Operations, and former chief executive officer said, “The opportunity to have Tony join Innocoll adds significant depth and experience to our executive team as we advance toward our goal of becoming a fully integrated pharmaceutical company. I look forward to working with Tony, on behalf of the entire company and its shareholders, to reach our business objectives.”

Mr. Zook has extensive pharmaceutical executive management, commercialization and marketing experience. He held several executive positions at AstraZeneca including executive vice president of Global Commercial Operations from 2010 to 2013, president and chief executive officer of the North American division from 2007 to 2010 and president of Medimmune from 2008 to 2010. Prior to joining Innocoll, Mr. Zook was chief executive officer and member of the Board of Directors of Vivus, Inc. in 2013. He has served or continues to serve on several boards including the boards of AltheRx, Inhibikase, Rib-X Pharmaceuticals, the National Pharmaceutical Council, PhRMA, the Pennsylvania Division of the American Cancer Society and his alma mater, Frostburg State University. Mr. Zook earned a B.S. degree from Frostburg State University and an A.A. degree in chemical engineering from Pennsylvania State University.

“I am excited to be joining the Innocoll team at this time in the company’s development,” said Mr. Zook. “Our late-clinical stage pipeline, which includes XaraColl, Cogenzia and CollaGUARD, is particularly promising as each candidate addresses patient needs in large global markets that are underserved today. I look forward to working with the Innocoll team to move our clinical candidates forward with the goal of bringing these important products to patients and their physicians in the near future.”

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company’s late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company’s approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals.

CollaRx^®, Collatamp^®, CollaGUARD^®, Collieva^®, CollaCare^®, Collexa^®, Cogenzia^® LidoColl^®, LiquiColl^®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the Company.

Forward-looking Statements

“Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the development of the Company’s product candidates, such as the timing and conduct of the Company’s Phase 3 clinical trials of XaraColl for the treatment of post operative pain and Cogenzia for the adjuvant treatment of diabetic foot infections, and clinical studies of CollaGUARD, our barrier for the prevention of post-surgical adhesions, pre-commercial activities, the advancement of the company’s earlier stage pipeline, future sales of CollatampG, CollaGUARD, RegenePro, Septocoll or other approved or marketed products, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including statements about the clinical trials of our product candidates. Such forward-looking statements involve substantial risks and uncertainties that could cause Innocoll’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing our products and product candidates, the initiation and conduct of clinical trials, delays in potential approvals by FDA of the commencement of trials, availability of data from clinical trials, positive results from such trials and expectations for regulatory approvals, the Company’s scientific approach and general development progress, the composition of the company’s supervisory board, the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the “Risk Factors” section of the final prospectus for the Company’s IPO, which is on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.”

CONTACT: Corporate:
         Denise Carter
         Executive Vice President Business Development
         and Corporate Affairs
         T: (215) 765-0149
         E: dcarter@innocollinc.com

         Investor relations:
         Robert Flamm, Ph.D.
         Senior Vice President
         Russo Partners, LLC.
         T: (212) 845-4226
         E: Robert.flamm@russopartnersllc.com

(CAPN) Presents CoSense® Data at the 2014 American Society of Hematology Annual Meeting

REDWOOD CITY, Calif., Dec. 8, 2014  — Capnia, Inc. (NASDAQ: CAPN), focused on the development of medical diagnostics based on its proprietary Sensalyze™ technology for precision metering of gas flow, today announced a poster presentation at the 2014 American Society of Hematology (ASH) Annual Meeting and Exposition, December 6-9, 2014, in San Francisco. The poster describes positive proof-of-concept data for the Company’s CoSense® ETCO Monitor in patients with sickle cell anemia (SCA), a disorder in which patients have chronic hemolysis. CoSense is a portable, non-invasive device that rapidly and accurately measures carbon monoxide in the exhaled breath and therefore measures the rate of hemolysis.

“Sickle cell anemia is the most common inherited lethal disorder and screening for it in resource constrained settings is a significant problem,” said Ashutosh Lal, M.D., Director, Thalassemia Program, The University of California San Francisco, Benioff Children’s Hospital Oakland, and the lead investigator for the study.  “Early mortality remains a significant problem in SCA patients in the areas of the world where the disease is most prevalent.  These findings provide scientific support for the further development of exhaled carbon monoxide measurement to monitor hemolysis in children with SCA and as a potential point-of-care screening test for SCA.”

“CoSense is currently FDA cleared and CE marked for the detection of hemolysis by measuring end-tidal carbon monoxide, or ETCO,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia.  “Based on the data from this study, CoSense can be an important tool for non-invasive point of care screening for babies at risk for SCA. We believe CoSense has potential applications in the monitoring of a range of diseases involving hemolysis and altered bilirubin metabolism and we appreciate being able to share these important findings with the hematology community at ASH this year.”

The following is a summary of the data presented at ASH:

Title: Elevated End-Tidal Carbon Monoxide Concentration in Children with Sickle Cell Anemia
Abstract #: 1390
Session: 114
Date and Time: Saturday, December 6, 2014, 5:30 PM-7:30 PM PT
Summary: Carbon monoxide (CO) produced during oxygen-dependent cleavage of porphyrin ring of heme is excreted in exhaled breath. The catabolism of heme is increased when red blood cells are destroyed at an accelerated rate. Thus, quantifying CO in exhaled breath could serve as an indicator of hemolysis.  However, the requirement for forced breath sample has precluded measurement of exhaled CO in young children. The goal of this single-center, open-label, non-randomized study was to assess passively-measured end-tidal CO concentration (ETCOc) in children with SCA.  In this study, 32 children (16 with SCA and 16 controls) ranging in age from 5-14 years were evaluated.

The study results demonstrated that the mean ETCOc was 5-fold higher in SCA compared with controls, with little overlap seen between the groups.  In addition, ETCOc measurements provided both sensitivity and specificity equal to 93.8% for distinguishing SCA from healthy children.  These results suggest that ETCOc may be a valuable tool for non-invasive monitoring of the severity of hemolysis in SCA and that ETCOc has potential for use as a point-of-care screening test for SCA.

About Capnia

Capnia, Inc. develops and commercializes diagnostics based on its proprietary Sensalyze™ technology for precision metering of gas flow.  Capnia’s lead product is CoSense®, which aids in the diagnosis of hemolysis, a dangerous condition in which red blood cells degrade rapidly. CoSense is a portable, non-invasive device that rapidly and accurately measures carbon monoxide in exhaled breath. CoSense has 510(k) clearance from the FDA and was launched in the U.S. in October 2014.  CoSense has also received CE Mark approval for sale in the E.U.

Forward-Looking Statements

This communication contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development and clinical trials; the timing of, and our ability to make, regulatory filings and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; the degree of clinical utility of our products, particularly in specific patient populations; our ability to develop commercial functions; expectations regarding product launch and revenue; our results of operations, cash needs, and spending of the proceeds from this offering; financial condition, liquidity, prospects, growth and strategies; the industry in which we operate; and the trends that may affect the industry or us.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that 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 presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate.

Capnia Contact:
David O’Toole
Chief Financial Officer
Capnia, Inc.
(650) 353-5146
dotoole@capnia.com

Investor Relations Contact:
Matthew Haines
Argot Partners
(646) 681-8192
matthew@argotpartners.com

(VTSS) Facilitates Adoption of MEF Third Network Vision

Recent analyst reports estimate the Carrier software-defined networking (SDN) and network functions virtualization (NFV) market will exceed $11 billion by 2018, with a growth rate of nearly 90% from today. While service provider network virtualization is still in developing stages, SDN and NFV will ultimately enable more agile, automated, and faster creation of revenue-generating services in carrier networks.

Anticipating these disruptive market trends, Vitesse Semiconductor Corporation (Nasdaq: VTSS), a leading provider of IC solutions to advance “Ethernet Everywhere” in Carrier, Enterprise and Internet of Things (IoT) networks, announced availability of an open, full duplex machine-programmable application programming interface (API) – JSON/RPC – for its CEServices™ software. This is an essential tool for enabling open-source SDN controllers to program all essential functions in an automated, programmatic model. CEServices is a comprehensive, mature protocol stack for easy provisioning and management of Carrier Ethernet business services.

With the JSON/RPC machine-to-machine (M2M) protocol, CEServices eclipses the rudimentary forwarding behavior of low-level APIs like OpenFlow, and extends SDN controller programming capabilities to:

• End-to-end service creation
• Operations, Administration and Maintenance (OAM)
• Quality of Service (QoS)

“Vitesse’s turnkey CEServices software and Serval Carrier Ethernet switch engine have already been integrated into the popular OpenDaylight controller, and is in customer SDN/NFV trials with large service providers,” said Uday Mudoi, vice president of product marketing at Vitesse. “We recognize the criticality of service agility in global networks and are committed to helping define open and standardized APIs as part of the MEF Third Network Initiative.”

About Vitesse

Vitesse (Nasdaq: VTSS) designs a diverse portfolio of high-performance semiconductors, application software, and integrated turnkey systems solutions for Carrier, Enterprise and Internet of Things (IoT) networks worldwide. Vitesse products enable the fastest-growing network infrastructure markets including Mobile Access/IP Edge, Cloud Access and Industrial-IoT Networking. Visit www.vitesse.com or follow us on Twitter @VitesseSemi.

Vitesse is a registered trademark and CEServices and Serval are trademarks of Vitesse Semiconductor Corporation in the United States and other jurisdictions. All other trademarks or registered trademarks mentioned herein are the property of their respective holders.

VTSS-G

Vitesse Semiconductor
Michelle Lozada, +1.805.388.3700
pressrelations@vitesse.com
www.vitesse.com
or
Agency Contact (Americas):
Interprose PR
Lisa McCausland, +1.303.888.2137
lisa.mccausland@interprosepr.com
www.interprosepr.com
or
Agency Contact (China):
Beijing New Synergy Consulting
Sharon Hu
+86 10 88144519/20 x 808
mhu@1AND7.com
www.1AND7.com

(XLRN) New Data in Myelodysplastic Syndromes At 56th American Society of Hematology

Celgene Corporation (NASDAQ:CELG) and Acceleron Pharma Inc. (NASDAQ:XLRN) today announced preliminary data from ongoing phase 2 clinical trials in patients with lower risk myelodysplastic syndromes (MDS) at the 56^th American Society of Hematology (ASH) Annual Meeting and Exposition. In his oral presentation, Dr. Uwe Platzbecker showed that patients with lower risk MDS treated with luspatercept achieved increased hemoglobin levels and transfusion independence. In a separate poster presentation, Dr. Rami Komrokji showed that lower risk MDS patients who were treated with sotatercept also achieved increased hemoglobin levels and transfusion independence. Celgene and Acceleron are jointly developing luspatercept and sotatercept.

“These results in lower risk MDS patients are very exciting,” said Uwe Platzbecker, M.D., Professor of Hematology and Head of the MDS program at the University Hospital in Dresden, Germany and coordinating principal investigator of the luspatercept PACE-MDS study. “Sotatercept and luspatercept may be useful early in the treatment of lower risk MDS patients, either as the initial treatment for anemia or in patients who do not respond or become refractory to treatment with ESAs. These investigational therapeutics have been very well-tolerated and therefore have the potential to benefit many MDS patients.”

Luspatercept Data Presented at ASH

In this study, luspatercept was evaluated in patients with low- or intermediate-1 risk MDS.

A total of 26 patients were treated in this dose-finding stage of the study in which luspatercept was administered subcutaneously once every 3 weeks for up to 5 doses (16 weeks) at doses of 0.125 (n=3), 0.25 (n=3), 0.5 (n=3), 0.75 (n=6), 1.0 (n=3) 1.33 (n=6), or 1.75 (n=2) mg/kg. Of these 26 patients, 19 had a high transfusion burden (≥4 units RBC/8 weeks) and 7 had a low transfusion burden (<4 units RBC/8 weeks). 54% of patients had been treated previously with erythropoiesis stimulating agents (ESA) and 19% of patients had previously been treated with lenalidomide.

Low Transfusion Burden (LTB) Patients:

• 4 of 5 (80%) LTB patients treated with doses of 0.75-1.75 mg/kg of luspatercept achieved the primary endpoint of hemoglobin increase ≥1.5 g/dL for ≥2 weeks in this 16 week study
• Additionally, 2 of 5 (40%) of LTB patients achieved the International Working Group (IWG) Hematologic Improvement Erythroid (HI-E) response criteria of a hemoglobin increase ≥1.5 g/dL for ≥8 weeks
• The mean maximum change for patients treated with luspatercept doses of 0.75. and 1.75 mg/kg was 2.2 and 3.5 g/dL, respectively
• All 5 LTB patients treated with luspatercept doses of 0.75-1.75 mg/kg had received prior ESA

High Transfusion Burden (HTB) Patients:

• 5 of 12 (42%) HTB patients treated with luspatercept doses of 0.75-1.75 mg/kg of achieved IWG HI-E criteria of a reduction of ≥4 units RBC over 8 weeks
• 3 of 12 (25%) HTB patients treated with luspatercept doses of 0.75-1.75 mg/kg achieved transfusion independence for ≥8 weeks

Emerging markers of response:

• As published earlier this year in Nature Medicine, the murine analog of luspatercept, RAP-536, can correct ineffective erythropoiesis in a mouse model of MDS
• Splicing factor 3B1 (SF3B1) mutations are seen commonly in MDS patients with ring sideroblasts and are associated with ineffective erythropoiesis
• Erythroid response (HI-E, IWG) was achieved in 41% of patients treated at ≥0.75 mg/kg. Erythroid response (HI-E, IWG) was achieved in 67% of patients with ring sideroblasts and SF3B1 mutations

The most common adverse events were diarrhea, muscle spasms, bone pain, fatigue, myalgia and nasopharyngitis. There were no drug-related serious adverse events. There was one possibly related grade 3 adverse event of blast cell count increase.

Sotatercept Data Presented at ASH

A second phase 2 study evaluated sotatercept in patients with low- or intermediate-1 risk MDS.

A total of 54 patients were treated in this dose-finding study in which sotatercept was administered subcutaneously once every 3 weeks at doses of 0.1 (n=7), 0.3 (n=6), 0.5 (n=21), and 1.0 (n=20) mg/kg. Of these 54 patients, 46 (85%) had a high transfusion burden (≥4 units RBC/8 weeks) and 8 (15%) had a low transfusion burden (<4 units RBC/8 weeks). 96% of patients had prior ESA, 57% had a prior hypomethylating agent, and 48% had prior lenalidomide.

Low Transfusion Burden (LTB) Patients:

• 5 (63%) patients achieved a mean hemoglobin increase ≥1.5 g/dL and transfusion independence sustained for ≥ 8 weeks
• Duration of transfusion independence ranged from 76 to 233 days
• Maximum mean hemoglobin increases ranged from 1.9 to 4.4 g/dL

High Transfusion Burden (HTB) Patients:

• 19 of 45 HTB patients (42%) achieved IWG HI-E criteria of a reduction ≥4 RBC units/8 weeks
• 5 HTB patients (11%) achieved transfusion independence
• Duration of transfusion independence ranged from 59 to 345+ days

The most common adverse events were fatigue/asthenia, headache, decreased appetite, nausea and dyspnea. 3 of 54 (6%) patients discontinued due to treatment emergent adverse events considered related to sotatercept. 1 patient with grade 2 hemolytic anemia; 1 patient with grade 3 hypertension; and 1 patient with grade 2 muscle weakness in the 0.3, 0.5, and 1.0 mg/kg dose groups, respectively.

About Luspatercept

Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-β) superfamily involved in the late stages of erythropoiesis (red blood cell production). Luspatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Luspatercept is currently in phase 2 clinical trials in patients with beta-thalassemia and in patients with myelodysplastic syndromes. For more information, please visit www.clinicaltrials.gov.

About Sotatercept

Sotatercept is an activin receptor type IIA fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-β) superfamily involved in the late stages of erythropoiesis (red blood cell production). Sotatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing sotatercept as part of a global collaboration. Sotatercept is currently in multiple phase 2 clinical trials. For more information, please visit www.clinicaltrials.gov.

About Acceleron

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action. These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company’s website at www.celgene.com. Follow us on Twitter @Celgene as well.

Forward-Looking Statements

Acceleron:
Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements about the Company’s strategy, future plans and prospects, including statements regarding the development of the Company’s compounds, including luspatercept and sotatercept, and the Company’s TGF-β superfamily program generally, the timeline for clinical development and regulatory approval of the Company’s compounds, the expected timing for the reporting of data from ongoing trials, and the structure of the Company’s planned or pending clinical trials. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the Company’s cash position will be insufficient to fund operations into the second half of 2017, that preclinical testing of the Company’s compounds and preliminary data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that data may not be available when we expect it to be, that the Company or its collaboration partner, Celgene, will be unable to successfully complete the clinical development of its compounds, that the development of the Company’s compounds will take longer or cost more than planned, that the Company may be delayed in initiating or completing any clinical trials, and that the Company’s compounds will not receive regulatory approval or become commercially successful products. Other risks and uncertainties include those identified under the heading “Risk Factors” included in the Company’s Annual Report on Form 10-K which was filed with the Securities and Exchange Commission (SEC) on March 17, 2014, and other filings that the Company may make with the SEC in the future. The forward-looking statements contained in this press release reflect the Company’s current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.

Celgene:

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

For Celgene:
Investors: 908-673-9628
investors@celgene.com
or
Media: 908-673-2275
media@celgene.com
or
For Acceleron
Investors:
Acceleron Pharma
Steven Ertel, 617-649-9234
Chief Business Officer
or
Media:
Suda Communications LLC
Maureen L. Suda, 585-387-9248

(CALA) Preclinical Study Findings for CB-839 Presented At 56th American Society of Hematology

-Potential Biomarkers of Response to CB-839 Identified in Myeloma Cells

-Synergy of CB-839 With Pomalidomide Demonstrated in Multiple Myeloma Models

SOUTH SAN FRANCISCO, Calif., Dec. 8, 2014  — Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, today announced preclinical data for its lead anti-cancer therapeutic candidate, CB-839, at the American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco, California. CB-839 is a potent, selective, orally bioavailable glutaminase inhibitor in phase I clinical trials.

“Data presented at this week’s ASH provides us with valuable insights into cellular metabolic properties that could ultimately direct our development of CB-839 towards the patients most likely to benefit from treatment. We have identified pyruvate carboxylase expression and functional read-outs of the mTORC1 pathway as possible biomarkers in our clinical studies of CB-839. Additionally, based on the pronounced synergy we observed preclinically with CB-839 and IMiDs, we are planning to initiate a Phase 1b trial treating myeloma patients with CB-839 plus pomalidomide and dexamethasone,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera.

Preclinical data was presented in a poster titled, “Biomarkers of Response to the Glutaminase Inhibitor CB-839 in Multiple Myeloma Cells,” on December 7, 2014 (Abstract #3429). High pyruvate carboxylase expression conferred inherent resistance to CB-839; those myeloma cells that did not express high levels of pyruvate carboxylase were sensitive to CB-839. In addition, the baseline metabolic profiles of CB-839 sensitive multiple myeloma cells were different from that of insensitive cells, suggesting that nutrient state and energy storage level in myeloma cells is an important factor in determining response to CB-839. Finally, the metabolic stress induced by CB-839 led to sustained inhibition of the nutrient senor mTORC1 in sensitive cells, with downstream effects on protein synthesis, nucleotide production and glycolysis.

Calithera also presented today at ASH the results of a study investigating the preclinical anti-tumor activity of CB-839 in combination with pomalidomide, demonstrating synergistic antiproliferative effects in IMiD-resistant cells in a poster titled, “Glutaminase Inhibitor CB-839 Synergizes with Pomalidomide in Preclinical Multiple Myeloma Models,” (Abstract #4720). The combination of CB-839 and pomalidomide produced enhanced effects on metabolic and signal transduction pathways likely contributing to the synergistic anti-proliferative activity.  In addition, in a multiple myeloma xenograft model, CB-839 showed significant single agent anti-tumor efficacy and displayed enhanced anti-tumor activity when combined with pomalidomide.

In addition, two posters were presented by Calithera’s collaborators. Details for the presentations are as follows:

Anti-Myeloma Activity of a Novel Glutaminase Inhibitor CB-839
Abstract #3439
Deepika Sharma Das, Ph.D., Dana Farber Cancer Institute
Poster Session 652 Myeloma: Pathophysiology and Pre-Clinical studies, excluding Therapy: Poster II

Efficacy of Novel Glutaminase Inhibitor CB-839 in Acute Myeloid Leukemia
Abstract #3763
Polina Matre, Ph.D., MD Anderson Cancer Center
Poster Session 616 Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

About Calithera Biosciences

Calithera Biosciences is a clinical-stage company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology. Calithera’s lead clinical candidate, CB-839, is a first-in-class inhibitor of glutaminase, a critical enzyme in tumor metabolism, and is currently being tested in patients with solid and hematological cancers. Calithera Biosciences is headquartered in South San Francisco. For more information about Calithera Biosciences, please visit www.calithera.com.

Forward Looking Statements

This news release contains forward-looking statements by Calithera that involve risks and uncertainties. These statements include those related to the advancement of Calithera’s tumor metabolism and tumor immunology therapeutics through clinical development and  Calithera’s plan to initiate a Phase 1b trial treating myeloma patients with CB-839 plus pomalidomide and dexamethasone; Actual results may differ from Calithera’s expectations and important factors that could cause actual results to differ materially. Calithera’s product candidates may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. In particular, future clinical trials may not show the synergy Calithera observed preclinically with CB-839 and IMiDs.  Furthermore, Calithera’s product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s Quarterly Report on Form 10-Q for the period ended September 30, 2014 and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

CONTACT: Jennifer McNealey
ir@Calithera.com
650-870-1071

(CBST) Acquisition By (MRK) Moves Forward, At $102 Per Share, Cash

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Cubist Pharmaceuticals, Inc. (NASDAQ:CBST) today announced that the companies have entered into a definitive agreement under which Merck will acquire Cubist for $102 per share in cash, which represents a 35 percent premium to Cubist’s average stock price for the most recent five trading days.

Unanimously approved by the boards of directors of both companies, the transaction has an equity valuation of $8.4 billion and will also include $1.1 billion in net debt (based on projected cash balances) and other considerations for a total transaction value of approximately $9.5 billion.

“Cubist is a global leader in antibiotics and has built a strong portfolio of both marketed and late-stage pipeline medicines,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “Combining this expertise with Merck’s strong capabilities and global reach will enable us to create a stronger position in hospital acute care while addressing critical areas of unmet medical need, such as antibiotic resistance.”

“Combining with Merck is an exciting opportunity to accelerate Cubist’s established leadership in antibiotics and deliver significant, certain and immediate value to shareholders,” said Michael Bonney, chief executive officer, Cubist. “We have a deep respect for Merck, and it is clear that they share our commitment to addressing the growing, global problem we are facing in combating antibiotic-resistant bacteria. Under Merck’s robust commercial platform, global reach and scientific expertise, we believe Cubist’s programs can thrive. We’re proud of the company that our team has built and are confident that Cubist’s important mission and focus on significant unmet medical needs will continue.”

For more than 20 years, Cubist has been committed to global public health through the discovery, development and supply of antibiotics to treat serious and potentially life-threatening infections caused by a broad range of increasingly drug-resistant bacteria. Cubist’s antibiotic CUBICIN^®, the only approved once-a-day therapy for both S. aureus bacteremia and complicated skin and skin structure infections (cSSSI), has been used to treat more than two million patients and continues to be an important therapy in the acute care environment. Cubist’s in-line and late-stage pipeline of anti-infective medicines, including ZERBAXA^™ which is pending approval from the U.S. Food and Drug Administration, will enhance Merck’s hospital acute care business in a variety of therapeutic areas, including Gram-positive and Gram-negative multi-drug resistant infections.

The acquisition of Cubist creates strong fundamental value with return on capital in excess of Merck’s hurdle rate within a few years of closing. Merck expects the acquisition to add more than $1 billion of revenue to its 2015 base. While the transaction will be neutral to non-GAAP EPS in 2015, Merck expects it to be significantly accretive to non-GAAP EPS in 2016 and beyond. The acquisition will be accretive to both Merck’s sales and earnings growth.

Cubist complements Merck’s strategy and the global initiative Merck launched last year, particularly in the area of sharpening its commercial focus on key therapeutic areas that have the potential to deliver the greatest return on investment. With the company’s long-standing leadership in anti-infectives as well as its customer-focused operating model, Merck identified the hospital acute care segment as one of the company’s key priority areas in which it believes it can have the greatest impact in addressing significant unmet medical needs while delivering the greatest value to customers and society.

Merck strategically focused on acute care within the larger hospital setting as a top priority because of the significant unmet need and the unique opportunities for Merck to improve patient care and manage costs in this setting with its in-line portfolio, promising pipeline and its customer capabilities.

Hospitals are a central hub for healthcare delivery around the world and currently represent 25 percent of overall healthcare spend. Merck believes now is an optimal time to significantly grow its hospital acute care presence because of the positive regulatory and reimbursement trends in the hospital setting and the increasingly important role that hospitals are expected to provide in healthcare overall.

For the first three quarters of 2014 compared to 2013, Merck’s hospital acute care portfolio grew by more than 10 percent, excluding the impact of foreign exchange. Key products in Merck’s hospital acute care portfolio include several antibiotics and antifungals, as well as BRIDION^® (sugammadex), which is marketed outside the United States and is currently under regulatory review in the United States. In addition, Merck has continued to invest in its hospital acute care pipeline and has several candidates, including actoxumab/bezlotoxumab (MK-3415A), an investigational combination of therapeutic antibodies targeting two C.difficile pathogenic toxins (A and B), which is being evaluated in clinical trials for the prevention of recurrence of C.difficile infection; and relebactam (MK-7655), an investigational class A and C beta-lactamase inhibitor being evaluated in clinical trials for the treatment of severe bacterial infections.

Under the terms of the agreement, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of Cubist Pharmaceuticals, Inc. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Cubist’s outstanding shares (assuming the exercise of all options), the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Upon the completion of the tender offer, Merck will acquire all remaining shares through a second-step merger without the need for a stockholder vote under Delaware law. The companies expect the transaction to close in the first quarter of 2015.

Important Information about the Tender Offer

The tender offer for the outstanding shares of Cubist has not yet commenced. This news release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for the tender offer materials that Merck and its subsidiary will file with the Securities and Exchange Commission (SEC). At the time the planned tender offer is commenced, a tender offer statement on Schedule TO will be filed by Merck with the SEC, and Cubist will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the tender offer. The tender offer materials (including an offer to purchase, a related letter of transmittal and other tender offer documents) and the solicitation/recommendation statement will contain important information that holders of Cubist common stock shares are urged to read carefully when they become available, as each may be amended or supplemented from time to time and because they will contain important information that holders of shares of Cubist common stock should consider before making any decision regarding tendering their shares. The tender offer materials will be made available to Cubist’s stockholders at no expense to them. In addition, all of those materials (and other tender offer documents filed with the SEC) will be made available at no charge on the SEC’s website at www.sec.gov. Additional copies of the tender offer materials may be obtained at no charge by contacting Merck at 2000 Galloping Hill Road, Kenilworth, N.J., 07033 or by phoning (908) 740-4000. In addition, Merck and Cubist file annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Merck or Cubist at the SEC public reference room at 100 F Street, N.E., Washington, D.C., 20549. For further information on the SEC public reference room, please call 1-800-SEC-0330. Merck’s and Cubist’s filings with the SEC are also available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

In this transaction, J.P. Morgan and Deutsche Bank served as financial advisors to Merck, and Hughes Hubbard & Reed LLP and Baker & McKenzie served as its legal advisors. Morgan Stanley & Co. LLC and Goldman, Sachs & Co. served as financial advisors to Cubist, and Ropes & Gray served as its legal advisor.

Investor Briefing Call

Merck will hold a call with institutional investors and analysts at 8:00 a.m. EST today, Dec. 8, 2014. Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 48773641. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 48773641. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the timing and closing of the tender offer and the merger transactions, the ability of Merck to complete the transactions considering the various closing conditions, and any assumptions underlying any of the foregoing. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the exposure to litigation, including patent litigation, and/or regulatory actions; timing of the tender offer and merger; uncertainties as to how many Cubist stockholders will tender shares in the tender offer; the possibility that competing offer may be made; the possibility that various closing conditions to transactions may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transactions; or that a material adverse effect occurs with respect to Cubist.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov).

About Cubist

Cubist Pharmaceuticals, Inc. is a global biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist’s corporate headquarters is based in Lexington, Massachusetts, with international headquarters located in Zurich, Switzerland. Additional information can be found at Cubist’s web site at www.cubist.com. Also, connect with Cubist on Twitter @cubistbiopharma and @cubistcareers, LinkedIn, or YouTube.

Cubist Forward-Looking Statement

This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding the timing and closing of the tender offer and the merger transactions and the ability of Cubist to complete the transaction are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others: the risk that Cubist stockholders will not tender shares in the tender offer; the possibility that competing offers may be made; the possibility that various closing conditions may not be satisfied or waived; or that a material adverse effect occurs with respect to Cubist; and those additional factors discussed in Cubist’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC. Cubist cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Cubist undertakes no obligation to update or revise any of these statements.

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Merck
Media Contacts:
Lainie Keller, 908-406-1459
or
Steve Cragle, 908-740-1801
or
Investor Contacts:
Joe Romanelli, 908-740-1986
or
Justin Holko, 908-740-1879
or
Cubist
Media Contact:
Julie DiCarlo, 781-860-8063
or
Investor Contact:
Eileen C. McIntyre, 781-860-8100

(KOOL) Appoints Mr. Denis Michael Rhein to Its Board of Directors

RANCHO CORDOVA, Calif., Dec. 5, 2014  — Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today announced that Mr. Denis Michael Rhein (54) has been appointed to the Company’s Board of Directors.

Mr. Rhein has over 30 years of corporate banking and securities experience at Deutsche Bank AG in Frankfurt, Germany. He served in various executive management positions including Managing Director, Senior Client Executive of Asset and Wealth Management, Global Head of Hedge Fund Research, Head of Alternative Investments, and Head of Product Development.

Mr. Rhein is the founder and Director of EMR Vermögensverwaltung GmbH, an investment management company. He is also the founder, Principal Shareholder and Director of Illumisound GmbH, an alternative energy efficient commercial lighting company. Mr. Rhein was a director of TotipotentRX Corporation from 2012 until the merger that resulted in the formation of Cesca Therapeutics in February 2014.

Robin C. Stracey, Chief Executive Officer and Director of Cesca Therapeutics said, “We are delighted to have Michael join our Board of Directors. His thirty years of international experience at one of Germany’s largest and most prestigious banks will bring valuable perspective to the Board. We look forward to working with him as we execute the Company’s growth strategy.”

About Cesca Therapeutics Inc.

Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of autologous cell-based therapeutics for use in regenerative medicine. We are a leader in developing and manufacturing automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:

• SurgWerks™ Platform, proprietary stem cell therapy point-of-care kit systems for treating vascular and orthopedic indications that integrate the following indication specific systems:
  • Cell harvesting
  • Cell processing and selection
  • Cell diagnostics
  • Cell delivery
• CellWerks^TM Platform, a proprietary stem cell laboratory kit for processing target cells used in the treatments of oncological and hematological disorders.
• AXP^® AutoXpress^® Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP^® MarrowXpress^® and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood.
• The MarrowXpress® Platform (MXP), a derivative product of the AXP and its accompanying disposable bag set, isolates and concentrates stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood from bone marrow to a user defined volume in 30 minutes, while retaining over 90% of the MNCs.
• The Res-Q™ 60 (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
• The BioArchive^® System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.

Forward Looking Statement

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics’ forward-looking statements is set forth under the caption “Risk Factors” in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

CONTACT: Cesca Therapeutics Inc.
         http://www.cescatherapeutics.com
         Investor Contact: Kirin Smith, ProActive Capital Group
         + 1-646-863-6519, or ir@cescatherapeutics.com

(ICPT) Publication of Meta-Analysis From the Global PBC Study Group in Gastroenterology

– Largest Analysis of Data from Patients with Primary Biliary Cirrhosis

– Alkaline Phosphatase (ALP) and Bilirubin Shown to Significantly Predict Clinical Outcomes

NEW YORK, Dec. 5, 2014  — Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver and intestinal diseases, announced today the publication of the meta-analysis performed by the Global Primary Biliary Cirrhosis Study Group (Global PBC Study Group) in the December issue of Gastroenterology. In the largest meta-analysis of individual PBC patient data conducted to date, researchers confirmed that levels of ALP and bilirubin predicted clinical outcomes of patients with PBC.

Of the 4,845 patients included in the analysis, 1,118 reached a clinical outcome defined as liver transplantation or death. For the first time, the researchers reported a log-linear association between ALP values and liver transplant-free survival. At one year after study enrollment, an ALP level of two times upper limit of normal (ULN) best predicted patient outcome (C statistic, 0.71) but not significantly better than other lower ALP thresholds such as 1.67 times ULN. Of patients with ALP levels less than or equal to two times ULN, 84% survived for over a ten year follow-up period compared with 62% of those with levels exceeding two times ULN (p < 0.0001). Elevated bilirubin levels were strongly predictive of a worse prognosis and only 41% of such patients had not had a liver transplant or died over the subsequent 10 years compared with 86% of patients with normal bilirubin levels (p < 0.0001).

The Global PBC Study Group analysis also showed that ALP and bilirubin were correlated with clinical outcomes consistently over time and in all the patient subgroups evaluated. Specifically, ALP was predictive of transplant-free survival in PBC patients both on and off standard of care treatment, those with histologically advanced or early stage disease, patients 45 years or younger or over 45 years at the time of diagnosis, female or male, and irrespective of the year of diagnosis.

“This study represents the largest international collaboration in PBC and provided us with a wealth of data supporting the use of this biochemical endpoint for therapeutic clinical trials,” said senior author Bettina Hansen, Ph.D., Department of Gastroenterology and Hepatology, Erasmus University Medical Centre in Rotterdam. “But the key takeaway from this analysis for everyday clinical practice is that the lower a patient’s ALP level and having a normal bilirubin level correlate with an improved prognosis for patients with PBC.”

The Global PBC Study Group consists of 15 leading PBC centers in eight countries that contributed to a clinical outcomes database of more than 6,000 patients with PBC. Data were analyzed under the direction of Dr. Bettina Hansen, Dr. Willem J. Lammers, Dr. Henk van Buuren and colleagues at Erasmus University Medical Centre in Rotterdam, the Netherlands. Intercept was a sponsor of this independent academic research program but was not involved in the study design, data collection, analysis or publication.

“We believe the Global PBC Study Group’s research supports the clinical relevance of a primary endpoint based on ALP and bilirubin in clinical trials of patients with PBC,” said David Shapiro, M.D., Chief Medical Officer of Intercept. “More broadly, it should enhance monitoring of disease progression and lead to better dialogue between clinicians and patients.”

“The work done by the Global PBC Study Group exemplifies the value of such cooperative initiatives in generating large clinical datasets that may provide evidence for the utility of proposed surrogate endpoints and a better understanding of the natural history of diseases such as PBC,” said Mark Pruzanski, M.D., CEO of Intercept. “We hope the Global PBC Study Group’s work continues in the future and would like to thank all of the researchers and patients involved in making such an invaluable contribution to the medical community’s understanding of this rare disease.”

About Primary Biliary Cirrhosis

PBC is an autoimmune liver disease that may progress to cirrhosis and liver failure, and it is currently the second leading indication for liver transplant among women in the United States. It is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. Ursodiol is the only approved drug treatment for PBC and studies have shown that up to 50% of PBC patients may have an inadequate response, thereby remaining at risk of adverse outcomes.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent chronic liver and intestinal diseases utilizing its expertise in bile acid chemistry. The company’s lead product candidate, obeticholic acid (OCA), is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases including primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), and primary sclerosing cholangitis (PSC). OCA has received Fast Track Designation in the United States and orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Several large, randomized, controlled studies of OCA in the treatment of chronic liver disease have been completed. These include Intercept’s Phase 3 POISE trial for the treatment of patients with PBC and the NIDDK-sponsored FLINT trial for the treatment of patients with NASH. The detailed results of POISE were previously reported in April 2014 and the primary endpoint was based on the achievement of both a reduction in ALP level to below a threshold of 1.67 times ULN, with a minimum of 15% reduction in ALP level from baseline, and a normal bilirubin level. Intercept owns worldwide rights to OCA outside of Japan, China and Korea, where it has out-licensed the product candidate to Sumitomo Dainippon Pharma. For more information about Intercept, please visit the company’s website at: www.interceptpharma.com.

Safe Harbor Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical relevance of the Global PBC Study Group data and the applicability thereof to OCA in PBC, the potential relationship between ALP and bilirubin and adverse clinical outcomes, the clinical utility of the POISE trial selected endpoints and any potential consensus relating thereto, clinical, preclinical and regulatory developments for our product candidates, the anticipated timetable for our clinical, regulatory and development activities, and our strategic directives under the caption “About Intercept.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and results of our development activities, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approval of OCA and any other product candidates we may develop, particularly the possibility that regulatory authorities may require clinical outcomes data (and not just results based on achievement of a surrogate endpoint) as a condition to any marketing approval for OCA, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; our plans to research, develop and commercialize our product candidates; the election by our collaborators to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; our ability to obtain and maintain intellectual property protection for its product candidates; our ability to successfully commercialize our product candidates; the size and growth of the markets for our product candidates and our ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; our need for and ability to obtain additional financing; our estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; our ability to retain key scientific or management personnel; and other factors discussed under the heading “Risk Factors” contained in our annual report on Form 10-K for the year ended December 31, 2013 filed on March 14, 2014 as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.

CONTACT: For more information about Intercept Pharmaceuticals,
         please contact:

         Intercept Pharmaceuticals:
         Barbara Duncan or Senthil Sundaram
         +1-646-747-1000
         investors@interceptpharma.com

         Media inquiries:
         Chantal Beaudry or Christopher Frates
         Lazar Partners
         + 1-212-867-1762
         Intercept@lazarpartners.com

(NMRX) Launches Enhanced Satellite Data Solution

Company Leads M2M Industry With New, Cost-Effective, Unlimited Satellite Data Plan

ATLANTA, Dec. 5, 2014 — Numerex (Nasdaq:NMRX), a leading provider of on-demand and interactive machine-to-machine (M2M) enterprise solutions enabling the Internet of Things (IoT), today announced that it has enhanced its service offering to provide an industry-leading unlimited satellite data plan specifically targeted for its suite of M2M products. This new service will be used to provide communications for M2M data collection and monitoring of customers’ assets that are deployed across the security, government, healthcare, energy and utilities, financial services, and transportation industries. In addition, the service plan includes mapping and analytic software and an API that can facilitate a data connection directly into a customer’s specific tracking application.

As M2M services move up the enterprise value chain, users prefer to monitor their assets more frequently throughout the day. Previous to this offering, satellite pricing levels for data transmission meant most companies limited their communications to just one or two messages per day. This resulted in GPS positioning data being received from far flung assets in the field only on an intermittent basis. With this new, economical, unlimited data plan, Numerex provides satellite tracking customers with a solution that allows them to more closely monitor their assets throughout each day, with updates transmitted as frequently as every five minutes.

“As an industry leading M2M Company offering an unlimited satellite data plan, Numerex continues to provide our customers with some of the most comprehensive and reliable satellite tracking options available in the market today,” said Scott Wiley, Senior Vice President of Marketing and Product Management. “The capability to acquire rich, near real-time transmissions from our M2M products allows our customers to respond quickly to the data flowing from their assets situated in virtually all regions of the world. The cost effectiveness of this solution opens up new possibilities and enables new value propositions for companies seeking high-frequency, near real time monitoring of widely dispersed assets located across town or across the globe.”

About Numerex

Numerex Corp. (Nasdaq:NMRX) is a leading provider of interactive and on-demand machine-to-machine (M2M) enterprise solutions enabling the Internet of Things (IoT). The Company provides its technology and services through its integrated M2M horizontal platforms, which are generally sold on a subscription basis. The Company offers Numerex DNA® solutions including hardware and smart Devices, cellular and satellite Network services, and software Applications utilizing Numerex solution technology. The Company also provides business services to enable the development of efficient, reliable, and secure solutions while accelerating deployment. Numerex is ISO 27001 information security-certified, highlighting the Company’s focus on M2M data security, service reliability and around-the-clock support of its customers’ M2M solutions. For additional information, please visit www.numerex.com.

Statements contained in this press release concerning Numerex that are not historical fact are “forward-looking” statements and involve important risks and uncertainties. Such risks and uncertainties, which are detailed in Numerex’s filings with the Securities and Exchange Commission, could cause Numerex’s results to differ materially from current expectations as expressed in this press release. These forward-looking statements speak only as of the date of this press release, and Numerex assumes no duty to update forward-looking statements.

© 2014 Numerex Corp. All rights reserved. Numerex, the Numerex logo and all other marks contained herein are trademarks of Numerex Corp. and/or Numerex-affiliated companies. All other marks contained herein are the property of their respective owners.

CONTACT: Numerex IR Contact:
         Seth Potter
         646-277-1230

         Media Contact:
         Valerie Christopherson
         Evan Sneider
         949-608-0276
         Numerex@globalresultspr.com

(QURE) to Present at the Oppenheimer 25th Healthcare Conference – NYC

AMSTERDAM, The Netherlands, Dec. 5, 2014  — uniQure N.V. (Nasdaq: QURE), a leader in human gene therapy, today announced that its management will present at the Oppenheimer 25th Healthcare Conference – NYC, to be held December 10-11, 2014, at The Crowne Plaza Hotel in New York City, NY, USA.

Date:  December 11, 2014
Time:  9:45 a.m. (EST)
Location:  The Crowne Plaza Hotel, New York City, NY, USA
Speaking for uniQure:  Jörn Aldag, Chief Executive Officer

To access a simultaneous webcast of Mr. Aldag’s presentation via the internet, log on to the “Events” section on the Media page of the uniQure website at http://www.uniqure.com/news/calendar-of-events/.

A replay of the webcast will be available from uniQure’s website for 30 days following the conference. Mr. Aldag’s presentation will be available for download in PDF format immediately following the conference presentation in the “Events” section of the Media page of uniQure’s website at http://www.uniqure.com/news/calendar-of-events/.

About uniQure
uniQure is delivering on the promise of gene therapy through single treatments with potentially curative results. We have developed a modular platform to rapidly bring new disease-modifying therapies to patients with severe disorders. We are engaged in multiple partnerships and have obtained regulatory approval of our lead product, Glybera, in the European Union for a subset of patients with LPLD. www.uniQure.com

uniQure:
Aicha Diba
Investor Relations
Direct : +31 20 240 6110
Main: +31 20 240 6000
a.diba@uniQure.com

Media inquiries:
Gretchen Schweitzer
MacDougall Biomedical Communications
Direct: +49 172 861 8540
Main: +49 89 2424 3494 or +1 781 235 3060
gschweitzer@macbiocom.com