Baxter International Inc. (NYSE:BAX) today announced the first approval of PREFLUCEL by the Austrian Agency for Health and Food Safety (AGES). The vaccine was shown to be effective in preventing seasonal influenza and is indicated for prophylaxis of influenza in adults and the elderly. PREFLUCEL is manufactured using Baxter's proprietary advanced Vero cell technology.
Vero cell technology offers an innovative method of vaccine production compared to conventional embryonated chicken egg production. Vero cell technology uses the natural virus, identical in protein composition to the virus circulating in nature, instead of genetically modified virus strains, which are used by egg manufacturers. This results in a high purity vaccine that is free of egg protein and free of antibiotics, and is suitable for adults and elderly populations, as well as people with egg or antibiotic allergies. In addition, PREFLUCEL is free of preservatives.
"Influenza is the world's most common vaccine-preventable disease, yet epidemics regularly claim the lives of hundreds of thousands of people each year," said Professor Markus Mueller, M.D., head of the Department of Clinical Pharmacology at the Medical University of Vienna. "We are encouraged by the potential of this new vaccine and the important role it can play in ensuring public health during the coming flu seasons."
PREFLUCEL contains antigens from the three distinct viral strains selected by the World Health Organization (WHO) as representative of circulating strains every year and has proven efficacy over the full influenza season, which lasts from October through May in the Northern Hemisphere. In a large placebo-controlled Phase III clinical study conducted in the U.S. during the 2008 to 2009 flu season, 7,236 individuals vaccinated with PREFLUCEL demonstrated a 78.5 percent protection rate against culture-confirmed influenza from influenza strains that matched those in the vaccine, and a 71.5 percent rate of prevention of influenza from all the circulating strains, including mismatched as well as drifted strains isolated during the study. These protection rates are consistent with what has been observed with licensed egg-derived seasonal influenza vaccines. The most common undesirable effects observed were pain at the injection site, headache, fatigue, myalgia and malaise, at rates similar to those observed with licensed egg-derived seasonal influenza vaccines.
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.
"Not only has PREFLUCEL demonstrated excellent immunogenicity with respect to the three viral strains identified as most likely to cause illness by the World Health Organization, but it also demonstrated a greater than 70 percent protection rate against all circulating flu strains," said Hartmut Ehrlich, M.D., vice president of global research and development and medical affairs for Baxter BioScience. "With the approval of PREFLUCEL, Baxter is pleased to offer its latest advancement in vaccine technology to effectively protect individuals and communities from influenza. We look forward to the successful introduction of PREFLUCEL in Austria and the Czech Republic this year and making it available in other countries in the near future."
PREFLUCEL is now available in Austria and will also be available in the Czech Republic during the 2010 to 2011 flu season. Baxter expects to submit for approval of PREFLUCEL in additional countries in Europe in 2010 through a Mutual Recognition Procedure (MRP). The MRP is used when marketing authorization (MA) has already been granted in one country, known as the Reference Member State, after which the MA holder seeks an MA in other European Member States.
In addition to European markets, Baxter continues to expand its development and licensing activities for this important vaccine through direct regional and national licensing processes. Already announced alliances include a cell culture technology alliance partnership with Takeda Pharmaceutical Company Limited in Japan and a continued influenza cell culture development partnership with U.S. based DynPort Vaccine Company LLC (DVC), a CSC company (NYSE: CSC) as part of a U.S. Department of Health and Human Services (DHHS), Office of the Assistant Secretary for Preparedness and Response, Office of Biomedical Advanced Research and Development Authority contract awarded to DVC in May 2006.
Baxter International Inc.,