Protein Sciences Partners File for Marketing Approval of Flublok® Influenza Vaccine in Japan
MERIDEN, Conn., May 30, 2014 /PRNewswire/ -- Protein Sciences Corporation announced today that Astellas Pharma has submitted an application for marketing approval of recombinant influenza HA vaccine ASP7374 (marketed as Flublok® in the United States by Protein Sciences) to the Ministry of Health, Labour and Welfare in Japan for the prevention of influenza. UMN Pharma, which is partnered with Astellas, holds an exclusive license from Protein Sciences for the development and marketing of Flublok in Japan. Protein Sciences will receive a significant milestone payment as a result of the filing.
The announcement made by Astellas Pharma and UMN Pharma can be found at http://ir.umnpharma.com/en/irnews/irnews-3759171731789488075/TopLink/TopLinkDocument/News_20140530_2.pdf.
Dan Adams, Executive Chairman and Global Head of Business Development at Protein Sciences said, "Japan is a terrific franchise for our BEVS platform as they value our broad technology platform for making recombinant vaccines and therapeutics that are fast to make, precise and pure. In addition to Japan, UMN Pharma has exclusively licensed Flublok and Panblok®, the pandemic version of Flublok, for the territories of China, Korea, Hong Kong, Taiwan and Singapore."
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, it contains 3x more protective ingredients than traditional flu 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). We have filed for FDA approval of Flublok for ages 50 and above and expect to receive approval in time for the 2014/15 influenza season.
Flublok Safety Information
Flublok 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.
SOURCE Protein Sciences Corporation