Protein Sciences Corporation, manufacturer of Flublok, is pleased to announce that Laboratorios Liomont, S.A. de C.V., a leading Mexican pharmaceutical company and licensee of Flublok for the Mexican market, has obtained approval from the Mexican regulatory agency COFEPRIS for Flublok for the prevention of influenza in adults 18 and older.
This is a landmark moment, as Flublok is the first recombinant influenza vaccine to be available in Mexico, offering pure and effective protection against the flu. Other influenza vaccines are made using 70 year old egg-based technology that is subject to mutations. The Mexican authorities also approved a 1 year shelf life and the use of the Flublok trade name.
“We are very pleased with the rapid approval of Flublok in Mexico and the approval of the longer shelf life,” said Manon Cox, President and CEO of Protein Sciences. “Recombinant technology is the only technology that can produce an influenza vaccine with the precision to exactly match circulating flu strains. We saw the benefit of this last year with a field study in 9,000 older adults that showed that Flublok protected people against the flu better than a traditional, egg-based flu vaccine—Flublok recipients were over 50% less likely to become infected with the mismatched H3N2 influenza strain that was the predominant circulating strain last season. In addition, Mexico will now also be a nation better prepared in the event of a pandemic as Flublok is expected to be available within 8-12 weeks post declaration of a pandemic.”
The rapid approval was the result of a strong team effort among many members of the Protein Sciences team, the National Autonomous University of Mexico and Liomont. Representatives from all three institutions will be present at a press conference today in Mexico City celebrating the approval.
Alfredo Rimoch, General Manager of Liomont, said, “For over 75 years we have been committed to the innovation and development of therapies to help relieve human suffering. Flublok’s new technology for influenza vaccination is our gateway to the field of biotech drugs and marks the start-up of our new Life Sciences division.”