U.S. Government Grants Additional Award to Bavarian Nordic for Development of MVA-BN as Safe Smallpox Vaccine

COPENHAGEN -- Bavarian Nordic A/S has been awarded Part B of the U.S. government's program to further develop MVA-BN as a safe third-generation smallpox vaccine. The award was granted to Bavarian Nordic for meeting appropriate milestones of Part A in the smallpox vaccine development program, and the potential of MVA-BN in being a successful MVA vaccine candidate. The award is an extension of Bavarian Nordic's current contract with the US government and is effective immediately.

The scope of the Part B option is to further study MVA-BN as a safe third-generation smallpox vaccine in Phase II clinical studies in healthy populations and Phase I and II studies in "at risk" (i.e. immune-compromised) populations. While Bavarian Nordic has successfully completed similar trials with MVABN outside the USA, the company is in discussions with the National Institute of Allergy and Infectious Diseases (NIAID) to finalize plans to conduct a Phase l study in HIV patients as the first study under Part B.

In August 2002, NIAID (a component within the National Institutes of Health) issued a Request for Proposal (RFP) for the early development of Modified Vaccinia Ankara (MVA) as a safe smallpox vaccine. This initial RFP had two parts, A and B. Part A was designed as a competitive milestone-based award worth a total of US$20 million over a three-year period. In February 2003, Part A was granted to Bavarian Nordic and the Acambis/Baxter alliance for the study of their respective MVA strains in preclinical animal studies and a Phase I clinical trial.

Part B, on the other hand, was an option to be awarded by the U.S. government only to a candidate vaccine that met the appropriate milestones in Part A and showed potential of being a successful MVA candidate vaccine. The award, with a potential value of $23 million, was to be granted in the form of extending the existing contract.

As previously reported, Bavarian Nordic has successfully met many of the milestones associated with the competitive portion (Part A) of the U.S. contract. Bavarian Nordic continues to be the leading company in the development of a safe third-generation smallpox vaccine, with an extensive preclinical efficacy data package on its proprietary MVA-BN as well as corresponding phase I and II clinical and safety data in over 250 healthy volunteers.

Commenting on the contract extension, Peter Wulff, CEO of Bavarian Nordic said, "We are extremely pleased that the US government has found MVA-BN to show potential of being a successful smallpox vaccine. This award adds further scientific credibility to the potential of MVA-BN as well as acknowledging the focus we have as an organisation to expedite the development of MVA-BN as a safe third-generation smallpox vaccine. The timing of this award puts Bavarian Nordic in an excellent position to respond to and win further smallpox vaccine contracts from the U.S. government as well as other markets."

Bavarian Nordic is a leading biopharmaceutical company in the field of innovative vaccines to prevent and treat infectious diseases.

During 2002, Bavarian Nordic was awarded several contracts for the supply of its safe third-generation MVA-BN smallpox vaccine and its Elstree-BN smallpox vaccine to, among others, the German and UK governments (the latter through an alliance with PowderJect). All of these manufacturing and supply contracts have either been fulfilled or are currently being fulfilled by Bavarian Nordic. In addition, Bavarian Nordic was awarded a three-year contract with the U.S. government's Department of Health and Human Services in February 2003 for the development of MVA-BN as a safe smallpox vaccine.

Source: Bavarian Nordic A/S

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