MERIDEN, Conn. and BUENOS AIRES, Argentina, April 19, 2016 /PRNewswire/ -- Protein Sciences Corporation (headquarters: Meriden, CT, USA), manufacturer of Flublok® influenza vaccine, Sinergium Biotech (headquarters: Buenos Aires, Argentina) and Mundo Sano, a private foundation with activities in Argentina, Spain and Africa, announced today that they have entered into an agreement to become members of a consortium that will jointly develop a Zika virus vaccine to combat the recent outbreak of Zika that is wreaking havoc in Latin America and spreading to other continents. Under the terms of the agreement, Sinergium will pay an upfront fee to fund the development and manufacture of the vaccine being produced at Protein Sciences using Protein Sciences' proprietary technology. In return, Sinergium will receive manufacturing and commercial rights to the vaccine in Argentina and other counties to be determined. The companies also said they are in active discussions with additional strategic partners worldwide that could strengthen and rapidly advance the development program.
The vaccine being developed is based on production of recombinant variations of the E protein from the Zika virus. Similar vaccine candidates produced at Protein Sciences against West Nile Virus and Japanese Encephalitis Virus, which are close relatives of the Zika virus, have previously been shown to neutralize their respective viruses in preclinical studies. Protein Sciences' technology is well known for its speed and safety, as it is used to manufacture the FDA-approved Flublok influenza vaccine and has been recognized by the U.S. government as the only approved technology that can respond to a pandemic influenza outbreak in time. The technology is plug-and-play, removing potential regulatory and safety hurdles that can dramatically delay novel vaccine development time lines.
Manon Cox, President and CEO of Protein Sciences said, "We are very pleased to partner with Sinergium Biotech and Mundo Sano on our Zika vaccine. Their focus on vaccine development and manufacturing make them a natural fit for the adoption of our technology." She added, "We initiated Zika vaccine development in February and are rapidly advancing vaccine candidates to the clinic. Sinergium's proximity to the heart of the outbreak opens up channels of support that would otherwise be inaccessible."
Alejandro Gil, President and CEO of Sinergium Biotech added, "This is an important step for our country to prevent Zika and an important step for our company that is committed to developing safely and rapidly different vaccines for the public health. We are also very enthusiastic to cooperate with Protein Sciences. Their great scientific technology and quality standards led to previous approvals of their influenza products in markets including FDA."
Silvia Gold, President of Mundo Sano Foundation said, "After more than 20 years working in the prevention of neglected diseases, and specifically the vector-transmitted ones, we are also very happy to be part of this consortium opening the opportunity of having a vaccine after WHO declared an imperative need of it."
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 initially approved by the U.S. FDA in January 2013 and the age range was expanded to make Flublok available to everyone over 18 years of age in October 2014. The FDA has accepted for filing and is reviewing Flublok Quadrivalent. 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).
Sinergium Biotech is an Argentinean biotech company focused on the development, manufacturing and marketing of different vaccines. Through a model of different strategic alliances with local and international partners, the know-how of new technologies was transferred into Argentina assuring a local supply of strategic products. Sinergium Biotech owns a 20,000 sqm production facility located in Garin, Buenos Aires, Argentina, with state-of-the-art technology aligned with the highest quality standards. Sinergium Biotech is currently manufacturing more than 13 million doses of different vaccines, including for seasonal influenza, pneumococcal and HPV.
About Mundo Sano
Mundo Sano Foundation was created in 1993, aiming to promote and create better conditions to improve the health of those exposed to neglected diseases. It works in increasing awareness, prevention, diagnosis and long-term treatment of communities affected in strategic locations of Argentina, Spain and Africa. It has created partnerships with authorities, universities, renowned scientists, civil societies, private partners and international organizations. Its community actions and investigations contribute to scientific knowledge. Learn more at www.mundosano.org.
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