Baxter Receives Marketing Authorization in European Union for VEPACEL Pre-Pandemic Influenza Vaccine
First Vero Cell Culture-Based Pre-Pandemic Influenza Vaccine Now Approved
VIENNA, Austria, March 2, 2012 - Baxter International Inc. (NYSE:BAX) announced today that the European Commission (EC) has granted marketing authorization for VEPACEL in all European Union (EU) Member States, as well as Iceland, Liechtenstein and Norway.
VEPACEL is a pre-pandemic influenza vaccine indicated for active immunization in adults 18 years and older (including immunocompromised and chronically ill patients) against the H5N1 subtype of influenza A (A/Vietnam1203/2004), commonly known as bird or avian flu. Pre-pandemic vaccination provides a level of protection against an emerging highly pathogenic influenza strain prior to an officially-declared pandemic. VEPACEL is manufactured using Baxter's proprietary advanced Vero cell technology.
"The approval of VEPACEL demonstrates Baxter's commitment to the production of pandemic and pre-pandemic vaccines to protect vulnerable individuals from the H5N1 virus," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business. "VEPACEL offers cross-protection against a broad range of H5N1 strains. It also results in a sustained immunological memory response, meaning that those who receive a 'booster' with a different pandemic strain vaccine will gain a rapid protective response to the pandemic virus."
VEPACEL is composed of purified, inactivated whole influenza virion, licensed as a suspension for injection containing 7.5 µg haemagglutinin (HA) antigen per 0.5 ml dose. VEPACEL clinical studies involved more than 4,700 people aged 18 to over 60 years. VEPACEL was well-tolerated and adverse events were mild and transient, the most common of which were pain at the injection site, headache and fatigue.
VEPACEL has the potential to generate a broader immune response than conventional egg-derived vaccines due to its use of Vero cell technology, which allows for use of the natural influenza virus (identical in protein composition to the virus circulating in nature) in vaccine production. Unlike traditional egg-grown influenza vaccines, eggs are not used in the VEPACEL manufacturing process. This is of particular significance for a vaccine protecting against an avian influenza strain such as H5N1 where the bird flocks needed for egg-based vaccine production may be adversely affected by the virus. VEPACEL is therefore free of egg protein, antibiotics and preservatives, making it also suitable for those with egg or antibiotic allergies.
About Avian Influenza (Bird Flu)
Vaccination is an important strategy in protecting the public against highly pathogenic strains of influenza and future pandemics. As the influenza virus continuously mutates, it has the ongoing potential to evolve into a highly pathogenic strain to which people have little or no immunity and may rapidly spread, resulting in a pandemic. Vaccination is effective in providing protection against strains of this type and may be given either during or before a pandemic occurs, the latter known as pre-pandemic vaccination. H5N1 (avian or bird flu) has been recognised by World Health Organization (WHO) as a strain of influenza having pandemic potential.i The availability of pre-pandemic vaccines effective against H5N1 is an important measure in governments' preparedness planning, including the stockpiling of vaccines in advance of a pandemic.
The H5N1 influenza (avian influenza) is highly pathogenic and affects both birds and humans and often leads to serious disease and death. As of 28 February 2012, 589 confirmed human cases of infection with avian influenza H5N1 from 15 countries had been reported to WHO in the period since 2003.ii The WHO estimates that the overall case-fatality rate for H5N1 in humans is 59 percent.ii
VEPACEL Safety Information
Clinical trials were conducted with VEPACEL in approximately 4,700 individuals (ranging in age from 18 to over 60 years) including special risk groups of approximately 300 individuals each, consisting of immunocompromised individuals and patients with chronic disease. The safety profile in the immunocompromised and in patients with chronic disease was shown to be similar to the safety profile in the healthy individuals. The most common side effects presented as pain at the site of injection, headache and fatigue.
VEPACEL is well tolerated and adverse reactions were mild and transient, the most common of which were pain at the site of injection, headache and fatigue.
For more detail on VEPACEL, see the Summary of Product Characteristics on the website of the European Medicines Agency (EMA) - http://www.ema.europa.eu .
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, 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 Baxter's vaccine product, VEPACEL, and the use of Vero cell technology. 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 Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.