Just a month after winning a big government contract for pandemic flu preparedness, Protein Sciences has notched an FDA approval for its next flu vaccine offering.
Starting next year, the Meriden, CT-based biotech will distribute its Flublok Quadrivalent shot, which targets four strains of the virus, hoping to gain some steam after facing challenges in the trivalent market. In its quest for big quadrivalent sales, the private biotech aims to quash the idea that its vaccines are only for people who are allergic to eggs.
Protein Sciences' new vaccine contains three times as much active ingredient as other quadrivalent options, the company says, making it a “great choice” for seniors and people with compromised immune systems. The company hasn't decided on a price.
Protein Sciences has some head-to-head data to tout in its bid for sales in the quadrivalent arena. In a study of nearly 9,000 adults aged 50 or older, Flublok recipients were more than 40% less likely to get lab-confirmed flu compared with those receiving GlaxoSmithKline’s Fluarix.
But the company will have formidable competition in the quadrivalent market, not only with GSK, but Sanofi and Seqirus as well. Each of those companies ships millions of vaccine doses to the U.S. each season across their respective portfolios.
The Protein Sciences product is different from traditional vaccines in that it's made using an egg-free process, making it suitable for people with egg allergies. Protein Sciences develops, harvests and purifies hemagglutinin proteins from insect cells, according to Medscape.
But the biotech is working hard to distance its vaccine from the “pigeonhole effect that Flublok is only for egg-allergic people,” CEO Manon Cox told FiercePharma, adding that the notion is an “absolute fable.”
"We believe that Flublok Quadrivalent is really going to be the product of choice in time," she said. "Even influenza vaccine manufacturers are recognizing that, over time, the egg-based production process will become obsolete and will be replaced with a more modern production process."
The company is seeking marketing partners for its vaccine. Cox said she believes it'll eventually "take over the market."
Protein Sciences is hoping to sell 900,000 trivalent vaccine doses this flu season, with a recent report by the Hartford Courant placing the tally sold so far just north of 300,000. According to wholesale price listings, the trivalent Flublok runs at about $39 per dose. It's $32.75 if purchased directly through the company.
Last year, Protein Sciences sold about 250,000 doses of Flublok trivalent.
The FDA approval comes quickly after Protein Sciences sealed a pandemic flu vaccine pact last month with the U.S. government’s BARDA potentially worth $610 million. Although it's unlikely the full value would be realized, the contract tasks Protein Sciences with getting "starting materials" ready so that the company could respond in the event of a flu pandemic or strain mismatch by major vaccine providers.
Protein Sciences’ cell culture flu vaccines can be produced more quickly than traditional flu vaccines, making them the only government-recognized products capable of responding to a pandemic, according to the company. Cox told the Courant last month that the arrangement would provide “stability … while we are building the flu business.”
Apart from its influenza vaccines, Protein Sciences is working in preclinical stages on vaccines against Zika and SARS.
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Editor's note: This story was updated with comments from Protein Sciences CEO Manon Cox.