VIENNA, Austria, March 2, 2011 - Baxter International Inc. announced today the approval of a European repeat mutual recognition procedure (rMRP) by the Austrian Agency for Health and Food Safety for Baxter's PREFLUCEL seasonal influenza vaccine. The 13 participating European Union countries, including Germany, Spain, United Kingdom and Nordic countries, will formally implement the license on a national level to make PREFLUCEL available for the 2011-12 influenza season.
PREFLUCEL, a seasonal vaccine composed of purified, inactivated split influenza virions, is the result of dedicated product development efforts to provide a well-tolerated and effective innovative vaccine that can be dependably manufactured for each influenza season. PREFLUCEL is manufactured using Vero cell technology, Baxter's proprietary technology platform, offering an innovative method of vaccine production compared to conventional embryonated chicken egg production, which has been used for decades. It is indicated for prophylaxis of influenza in adults older than 18 years and elderly populations.
"Baxter is encouraged by the rMRP approval of PREFLUCEL and looks forward to making this vaccine available in many countries in Europe," said Hartmut Ehrlich, M.D., vice president of global research and development for Baxter's BioScience business. "We are committed to offering our latest advancement in vaccine technology to effectively protect individuals and communities from seasonal influenza."
Results of a recently published study in The Lancet demonstrated effectiveness and tolerability of Baxter's PREFLUCEL in protecting against seasonal influenza. The study data showed 78.5 percent protective efficacy against the influenza strains contained in the vaccine and a low adverse event profile.
Production of PREFLUCEL using Baxter's Vero cell technology allows for the use of the natural virus, which is identical in protein composition to the virus circulating in nature. Egg-based vaccine production cannot use the natural virus, and must instead wait until genetically modified virus strains are available. PREFLUCEL is free of preservatives, antibiotics and egg proteins, and is suitable for adult and elderly populations, as well as people with egg or antibiotic allergies in those age groups.
Investigators studied the safety, immunogenicity and protective efficacy of PREFLUCEL through a randomized, double-blind, placebo-controlled phase III trial conducted in more than 7,200 healthy volunteers in the United States during the 2008/2009 influenza season1.
Study results indicated that participants responded positively to the vaccine, with 78.5 percent protective efficacy against culture-confirmed influenza infection (CCII) and robust immune responses (measured as seroprotection rates) against the three viral strains contained in the vaccine: A/H1N1- (88.0%), A/H3N2- (93.3%) and B-specific (97.1%). The vaccine was well tolerated, with no treatment-related serious adverse events reported during the trial. The strong immune response of PREFLUCEL was further demonstrated by meeting the criteria for immunogenicity set by the European Medicines Agency and the U.S. Food and Drug Administration in all Phase III clinical studies completed.
PREFLUCEL clinical studies involved more than 15,000 participants, of which more than 9,000 adult and elderly participants received the vaccine. The most common adverse reactions were pain at the injection site, headache, fatigue, myalgia and malaise.
Baxter International Inc. (NYSE: BAX), through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning the company's Vero cell technology and expectations with respect to the approval of PREFLUCEL in additional European countries in 2011. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; market acceptance of vaccines developed with Vero cell technology; and other risks identified in the company's most recent filing on Form 10-K and other Securities and Exchange Commission filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.
1Barrett, N. et al. Efficacy, safety, and immunogenicity of a Vero-cell culture-derived trivalent influenza vaccine: a multicentre, double-blind, randomised, placebo-controlled trial. The Lancet, published online February 16, 2011,DOI:10.1016/S0140-6736(10)62228-3.