MERIDEN, Conn. and STOCKHOLM, Sept. 16, 2014 /PRNewswire/ -- Protein Sciences Corporation and Diamyd Medical AB announced today that Protein Sciences has broadened its commitment to diabetes and become a strategic and significant shareholder in Diamyd Medical, its long-time partner in this domain. Protein Sciences will manufacture product for upcoming late stage clinical trials for type 1 diabetes involving Diamyd Medical's recombinant GAD (glutamic acid decarboxylase) protein made using Protein Sciences' proprietary BEVS technology. The diabetes vaccine Diamyd® (GAD formulated with alum) has been evaluated as a monotherapy for type 1 diabetes in a Phase 3 study and data suggests Diamyd® may be a critical component of combination therapies that pair the tolerance-inducing GAD antigen with anti-inflammatory agents for the treatment and prevention of type 1 diabetes. This is being evaluated in ongoing and upcoming Phase 2 studies.
Under the Agreement Diamyd Medical is placing an order for cGMP production of recombinant GAD protein for which Protein Sciences receives a cash payment and 400,000 new series B shares in Diamyd Medical corresponding to a 2.0% ownership in Diamyd Medical. The ownership stake will make Protein Sciences a strategic and one of the largest shareholders in Diamyd Medical. One hundred thousand of the new shares will be issued upon entering the Agreement and the remainder at completion of production. The shares will be issued under the Annual General Meeting's authorization of the Board.
"Diamyd Medical has been a longstanding partner of Protein Sciences, and we believe their approach to treating diabetes holds great promise," said Dan Adams, Executive Chairman of Protein Sciences. He continued, "The GAD product is an excellent demonstration of the versatility of our BEVS platform that can be used to make a wide variety of products, including our revolutionary Flublok® influenza vaccine."
Anders Essen-Moller, Chairman of Diamyd Medical said, "It is strategically important for the development of Diamyd that the relationship between manufacturing and commercialization is deepened and we welcome Protein Sciences to become one of our largest shareholders." He added, "We believe their technology is the best for making recombinant proteins such as GAD. FDA approval of Flublok only makes the platform more valuable to partners such as us, as the significant regulatory hurdles that typically face new technologies have already been cleared."
About Protein Sciences Protein Sciences is a vaccine development and protein production company that is dedicated to saving lives and improving health through the creation of innovative vaccines and biopharmaceuticals. Flublok, the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease, was approved by FDA in January 2013. Flublok is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing. Flublok is highly purified and does not contain any preservatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex. In addition, Flublok is triple the strength of conventional influenza vaccines. Flublok is a perfect copy of the virus coat and is not subject to the egg-adapted mutations associated with low vaccine effectiveness (see Skowronski et al. (2014) PLOS ONE 9(3), e92153). Protein Sciences has filed for FDA approval of Flublok for ages 50 and above and expects to receive approval in time for the 2014/15 influenza season.
Healthcare professionals in the U.S. can order Flublok by contacting FFF Enterprises at 800-843-7477 or ASD Specialty Healthcare at 866-281-4FLU.
Learn more at www.proteinsciences.com and www.flublok.com.
About Diamyd MedicalDiamyd Medical is a publicly traded diabetes company headquartered in Stockholm, Sweden. The Company develops the diabetes vaccine Diamyd®, an Antigen Based Therapy (ABT) with the active ingredient GAD, which has the potential to become a key piece of the puzzle of a future solution to prevent, treat or cure type 1 diabetes and other forms of autoimmune diabetes. Diamyd Medical has independently pursued the development of Diamyd® to global Phase 3 trials, leading to one of Sweden's largest biotech agreements ever. Diamyd Medical's series B share is traded on NASDAQ OMX First North under the ticker DMYD B.
Learn more at www.diamyd.com.
Flublok Safety InformationFlublok is approved for people 18-49 years old to prevent influenza disease. The most common side effect from Flublok is pain at the site of injection. Other side effects may occur and include fatigue, headache and muscle aches.
Flublok should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component.
Tell the doctor if you have ever experienced Guillain-Barre syndrome (severe muscle weakness) within 6 weeks of receipt of a previous dose of influenza vaccine. If you notice any other problems or symptoms following vaccination, please contact your healthcare professional immediately. Vaccination with Flublok may not protect all individuals.
Please see the complete Package Insert available at www.flublok.com or call 203-686-0800 for more information.
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SOURCE Protein Sciences Corporation
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