A Brazilian biopharmaceutical partnership will seek regulatory approval in Brazil to market Flublok, a technologically innovative influenza vaccine developed by Connecticut-based Protein Sciences Corp., which operates a manufacturing facility on the former Pfizer Inc. campus in Pearl River.
Officials at Protein Sciences headquarters in Meriden, Conn., recently announced the exclusive licensing agreement with Orygen Biotecnologia SA, a joint venture between the Brazilian pharmaceutical companies Eurofarma Laboratórios SA and Biolab Sanus Farmaceutica Ltd. If Brazilian regulators approve the protein-based vaccine, Orygen will market Flublok there. Protein Sciences will manufacture the vaccine and receive “significant” license and commercial milestone payments, according to the companies. Financial terms of the deal were not disclosed.
The companies said Brazil has experienced a severe and lethal outbreak of H1N1 swine flu in recent months. The viral infection 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.
Approved by the Food and Drug Administration in 2013 for use by adults in the .US., Flublok, unlike traditional vaccines, is made in an egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing. Instead Protein Sciences uses recombinant DNA and a modified virus that infects insects to produce large quantities of hemagglutinin protein, the active ingredient in flu vaccines.
Manon Cox, president and CEO of Protein Sciences, said the partnership with Orygen “gives a 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.”
