MERIDEN, Conn. and SÃO PAULO, April 12, 2016 /PRNewswire/ -- Protein Sciences Corporation and Orygen Biotecnologia SA, a joint venture between the Brazilian pharmaceutical companies Eurofarma Laboratórios SA and Biolab Sanus Farmaceutica Ltda, announced today that they have agreed on the terms of a licensing partnership that grants Orygen an exclusive license to Flublok® influenza vaccine for the Brazilian market. Brazil is experiencing a severe outbreak of H1N1 swine flu that has killed almost twice as many people over the past three months as it did in all of 2015, according to Brazil's Health Ministry, evidencing the need for effective influenza prevention. Flublok is the world's first recombinant influenza vaccine that has been shown in a recent large field trial to provide significantly better protection against the flu than a traditional, egg-based influenza vaccine. Under the terms of the agreement, Orygen will seek regulatory approval for and will market Flublok in Brazil. Protein Sciences will manufacture Flublok and will receive significant license and commercial milestone payments.
Andrew Simpson, Scientific Director of Orygen said, "Flublok represents an advance in the performance and quality of an influenza vaccine that will be a welcome addition in Brazil. We admire this achievement of Protein Sciences and are very pleased to be their partner in bringing Flublok to the Brazilian people."
Manon Cox, President and CEO of Protein Sciences said, "Our partnership with Orygen gives way for Flublok to enter the Southern Hemisphere, which has an opposite flu season from the Northern Hemisphere, and thereby opens up a second sales cycle for the vaccine." She added, "Orygen is a young but highly professional company with founders that have deep roots in pharmaceuticals. We expect our relationship will have long-lasting benefits."
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.
Orygen is a Brazilian biopharmaceutical company focused the development, manufacture and marketing of therapeutic monoclonal antibodies and vaccines for disorders that affect Brazil and other emerging economies.
Flublok, the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease, was approved by the U.S. 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 contains three times more antigen than traditional flu vaccines (3x45mcg hemagglutinin protein versus 3x15mcg hemagglutinin protein)*. 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).
Flublok Safety Information
Flublok is approved for people 18 and older to prevent influenza disease. The most common side effect from Flublok is pain at the site of injection. Headache, fatigue or muscle ache may occur. Tell the doctor if you have ever experienced Guillain-Barré syndrome (severe muscle weakness) or have had a severe allergic reaction to any component of Flublok vaccine. Vaccination with Flublok may not protect all individuals. Clinical effectiveness in adults 50 and older is based on the immune response elicited by Flublok and not on demonstration of decreased influenza disease. Please see the complete Package Insert available at www.flublok.com or call 203-686-0800 for more information.
*Flublok demonstrated a higher antibody response to the A strains during 2 clinical trials in adults ≥50 years old. The B strain antibody response was comparable to traditional trivalent vaccines.
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SOURCE Protein Sciences Corporation