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Biotech / Medical : Bioterrorism

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To: nigel bates who wrote (792)9/30/2004 4:42:38 AM
From: nigel bates   of 891
 
Bavarian Nordic Awarded a USD 100 Million Contract From US Government to Further Develop IMVAMUNE(TM) as Safe Smallpox Vaccine

KVISTGÃ…RD, Denmark, September 30 /PRNewswire/ -- Announcement no. 24-04: The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, today awarded Bavarian Nordic A/S (Copenhagen: BAVA.CO - news) a three-year contract to further develop its patented IMVAMUNE(TM) as a safe smallpox vaccine. The value of the contract is more than USD 100 million and is effective immediately.

The contract calls for the manufacture of 500,000 doses of IMVAMUNE(TM) vaccine within 11 months of con-tract award using the final validated production process. It also outlines an option for the US government to purchase an additional 2,5 million doses of IMVAMUNE(TM) vaccine during the contract period for a further USD 41 million. In addition, the contract requires further clinical development of IMVAMUNE(TM) and validation of animal models.

This is the second smallpox vaccine development contract awarded to Bavarian Nordic from NIAID. The first contract was awarded to the company in February 2003 followed by a supplemental award in September 2003.

As mentioned previously, GlaxoSmithKline (LSE: GSK.L - news - msgs) will collaborate with Bavarian Nordic as a commercial partner in future US government programmes, including the forthcoming Request for Proposal-lll (RFP-lll) which is expected to include the purchase of up to 60 million doses of MVA smallpox vaccine. RFP-lll is expected to be issued before year-end.

The announcement of the US Government award is not expected to affect Bavarian Nordic's expectations for 2004, which remain a turnover of DKK 400 million and a net income before tax of DKK 60-80 million.

Copenhagen, 30 September 2004

Asger Aamund, Chairman of the Board

About Bavarian Nordic:

Founded in 1994, Bavarian Nordic A/S is a leading international biopharmaceutical company developing, producing and marketing innovative vaccines to prevent and treat infectious diseases. With operations in Denmark and Germany, Bavarian Nordic employs over 125 people and is listed on the Copenhagen Stock Exchange under the trading symbol BAVA.

Bavarian Nordic's patented core technology, MVA-BN(R), is one of the world's safest, multivalent vaccine vectors and is ideally suited for use against various infectious diseases such as smallpox, HIV/AIDS, Japanese Encephalitis and Dengue Fever. Several MVA-BN(R)-based HIV and smallpox vaccines are in clinical Phase I and Phase II trials. MVA-BN(R) is patented under US Patent No. 6,761,893 and covers the MVA-BN(R) virus and derivatives thereof, IMVAMUNE(TM) (Bavarian Nordic's smallpox vaccine), and its use as a vector technology.

With respect to smallpox vaccines, Bavarian Nordic has supply and development contracts with the governments of Germany, the U.S.A., and other countries. One of the company's agreements includes a contract (awarded in February 2003) with the U.S. Department of Health and Human Services to develop MVA-BN(R) as a safe third-generation smallpox vaccine. Bavarian Nordic's advanced development program has been further expedited by the US governement with the FDA's grant of "fast track" status for IMVAMUNE(TM), the first and only smallpox vaccine candidate to be given this designation. Bavarian Nordic is one of the few companies in the world able to supply the growing demand for smallpox vaccines, particularly safe smallpox vaccines. With a combined global manufacturing capacity consisting of its own production facility in Denmark (able to produce up to 120 million doses per year) an international collaboration with GlaxoSmithKline, and the long-standing partnership with vaccine producer, Impfstoffwerk Dessau-Tornau (IDT (NYSE: IDTc - news) ), Bavarian Nordic has ensured supply of its current and future vaccines.

Bavarian Nordic's partners include GlaxoSmithKline worldwide, Epimmune (NASDAQ: EPMN - news) in the U.S.A., Gerolymatos in Greece, Impfstoffwerk Dessau-Tornau (IDT) in Germany, and Vaccine Solutions in Australia.

For more information please visit www.bavarian-nordic.com
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