Baxter International Inc., a global health care company, reported that a subsidiary's tick-borne encephalitis vaccine, FSME-IMMUN 0.5 ml, received approval for adult use in Germany from the Paul Ehrlich Institute (PEI), the regulatory authority in Germany.
Tick-borne encephalitis (TBE) is caused by viral infection transmitted by tick bites in specific areas in Europe and the Eastern part of Russia. In Germany, up to several hundred TBE cases occur each year among individuals who are not vaccinated against the disease. The virus, once contracted, can cause severe damage to the central and peripheral nervous system with long-term medical complications. One to two percent of infected patients die from the infection. Today patients have no alternatives for treatment, so prevention is of utmost importance for people at risk for tick bites in endemic areas.
"This new product license positions us well to continue growing our vaccines business, and highlights the continued progress we are making towards our growth objectives by meeting our clinical and regulatory milestones," said Thomas Glanzmann, senior vice president and president of Baxter's BioScience business.
Baxter was the first company in Western Europe to bring a tick-borne encephalitis vaccine to market, in 1976. Baxter modified the manufacturing process for the vaccine in 2001, which required further clinical trials to demonstrate safety and effectiveness. Clinical trials of the vaccine in children are still ongoing in Germany and approval is expected in 2004.
Baxter has a broad pipeline of vaccines, with more than a dozen vaccines at all stages of development from pre-clinical to pre-launch, including influenza and various meningococcal combination conjugates. Baxter's NeisVac-C meningococcal vaccine currently is licensed in 15 countries, and the company is participating in the production of approximately 155 million doses of smallpox vaccine, in conjunction with Acambis Inc. on behalf of the U.S. Department of Health and Human Services. Earlier this year, Baxter received regulatory approval in the Netherlands for InfluJect, a novel new influenza vaccine. The company is pursuing regulatory approval for InfluJect in other European countries in 2002 and 2003, and plans to initiate clinical trials in the United States in 2002.