Protein Sciences New York Facility Receives FDA Licensure to Manufacture Flublok®

MERIDEN, Conn., May 13, 2015 /PRNewswire/ -- Protein Sciences Corporation announced that on May 12, 2015 the U.S. Food and Drug Administration (FDA) licensed its Pearl River, NY manufacturing facility for the commercial manufacturing of Flublok^® influenza vaccine.  Flublok is the world's first licensed influenza vaccine made using modern recombinant technology. 

"The approval of our Pearl River facility accelerates the growth of Protein Sciences and Flublok," said Manon Cox, President and CEO. "We will be able to manufacture Flublok at four times the scale compared to our Connecticut facility.  This milestone enables us to substantially increase the availability of Flublok this year and in the future." 

"Approval of the Pearl River facility has been our passion since we acquired the facility from Pfizer at the end of 2012," said Mireli Fino, Vice President of Manufacturing Operations. "It has been very rewarding to work with our dedicated Pearl River team that was able to manufacture the first batch of Flublok within 100 days and to now achieve FDA licensure.  We look forward to the new opportunities licensure presents."

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. HHSO100200900106C.

For more information about Flublok, please visit www.flublok.com.

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 pre-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

Learn more at www.proteinsciences.com and www.flublok.com.

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.

Logo - http://photos.prnewswire.com/prnh/20140617/118909

SOURCE Protein Sciences Corporation

Related Links

http://www.proteinsciences.com