Bavarian Nordic Demonstrates Significant Progress to Provide World With Safe Smallpox Vaccine

WASHINGTON and COPENHAGEN, Denmark -- International biopharmaceutical company Bavarian Nordic released its third quarter accomplishments relating to the development, production and marketing of innovative vaccines that prevent and treat infectious diseases.

"The company's pursuit of a safe smallpox vaccine for people around the globe has achieved extraordinary strides over the past year," said Peter Wulff, president and CEO of Bavarian Nordic. "Our groundbreaking MVA smallpox vaccine is seen by many scientific and health policy experts as a safe, effective alternative to the traditional -- or second-generation -- smallpox vaccines currently stockpiled by world governments."

According to the Institute of Medicine, the current stockpiled vaccines can cause dangerous complications, ranging from generalized rashes to encephalitis and heart problems in nearly 25 percent to 30 percent of the general population. They are not considered safe for small children, senior citizens and the immune-compromised.

Bavarian Nordic's MVA smallpox vaccine, known as IMVAMUNE, is a weakened, non-replicating form of the virus. It is currently undergoing clinical trials with the U.S. Food and Drug Administration (FDA) to be confirmed as a safe smallpox vaccine. The company's global clinical development program has already generated data on the safety of IMVAMUNE in persons with HIV as well as optimal dosing for the vaccine while an ongoing trial is investigating IMVAMUNE in persons with atopic disorders, such as eczema.

Earlier this year, the FDA also awarded IMVAMUNE its first-ever "fast track" status to a smallpox vaccine -- a designation that is intended to facilitate the development and expedite the review of new therapies targeted at treating serious and life-threatening conditions.

Taking into account the significant health risks associated with the current vaccine stockpile in 2002 the U.S. government began development of MVA, as a safe and easily-administered smallpox vaccine under the lead of the National Institute of Allergy and Infectious Diseases (NIAID). Based on the merits of the MVA technology, NIAID last month awarded Bavarian Nordic its second in a series of contracts* valued at more than $141 million to further develop IMVAMUNE as a safe smallpox vaccine.

"While Bavarian Nordic will continue to take the lead in the development of IMVAMUNE under the NIAID program, we will closely collaborate with our commercial partner GlaxoSmithKline in pursuing future government programs, including the forthcoming Request for Proposal III," added Wulff. RFP-III will outline the U.S. government's purchase of up to 60 million doses of a safe smallpox vaccine and is expected to be issued before year-end.

* The award of RFP-II has been funded in full or in part with federal funds from the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN266200400072C, ADB Contract No. 1-AI-40072.

Source: Bavarian Nordic

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