MERIDEN, Conn., Nov. 18, 2015 /PRNewswire/ -- Protein Sciences Corporation, manufacturer of Flublok®, is pleased to announce that Laboratorios Liomont, S.A. de C.V. (Liomont), 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."
Click here to read more about the licensing agreement between Protein Sciences and Liomont.
About Protein Sciences
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.
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% 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).
Healthcare professionals wishing to order Flublok should contact one of the following distributors:
- FFF Enterprises: 800-843-7477 www.myfluvaccine.com
- Cardinal Health: 866-677-4844 http://www.cardinal.com/us/en/SPD/Ordering
- McKesson: 877-MCK-4FLU mms.mckesson.com
- Henry Schein: 1-800-772-4346 www.henryschein.com
Liomont is a 100% Mexican pharmaceutical company established in 1938, ranked number 8 in the national pharmaceutical market in units and 16 in value in 2014, with high quality prescription and OTC products. It has one of the most dynamic growth rates in the market. Liomont has a capacity of more than 120 million units per year in a high tech facility considered to be one of the most modern in Latin America. It has approximately 1500 employees of which more than half are medical sales reps with the aim of creating a solid and collaborative team. In addition to marketing activities, Liomont has the social mission to be a source of employment, training and development of its people to ensure a better quality of life. The Company has received the Socially Responsible Company Award for 10 continuous years due to its outstanding commitment to society. Other public and private institutions have also recognized several initiatives in business and ecology among others.
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-Barre 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.
SOURCE Protein Sciences Corporation