In a rare move, the US Food and Drug Administration (FDA) has granted exclusivity to Protein Sciences Corporation's Flublok for a period of 12 years.
Flublok is the first vaccine awarded this very important status, demonstrating Flublok as a unique and game changing influenza vaccine.
The US FDA determination of regulatory exclusivity means that no product similar to Flublok can be approved by US FDA before January 16, 2025.
"The FDA's designation prevents a generic product maker from capitalising on the hard work of our team," said Manon Cox, president and chief executive officer of Protein Sciences Corporation. "We are delighted that the FDA recognises Flublok as a singular innovation in the prevention of an important and often deadly disease caused by the influenza virus."
"I am honoured to be representing Protein Sciences Corporation for nearly twenty years on matters of legal exclusivity," said Tom Kowalski, Esq., Shareholder with Vedder Price, P.C. "This biologics regulatory exclusivity is only the third of such exclusivities granted by the US FDA under the Affordable Care Act, and the only one for an influenza vaccine."
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 per cent 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.
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. Clinical effectiveness in adults 50 and older is based on the immune response elicited by Flublok and not on demonstration of decreased influenza disease.
Protein Sciences specializes in vaccine development and protein production. Our mission is our inspiration: to save lives and improve health through the creation of innovative vaccines and biopharmaceuticals.