In a business update, Danish-based biopharmaceutical company Bavarian Nordic, reported a number of developments in its vaccine project pipeline.
Clinical development of IMVAMUNE(R) as a safe smallpox vaccine is proceeding as planned. Phase III studies with IMVAMUNE(R) in healthy subjects are expected to be initiated in 2008.
Bavarian Nordic received an advance payment of $50 million from the Department of Health and Human Services (HHS) as allowed under the RFP-3 contract. The contract calls for the manufacture and delivery of 20 million doses of the company's, IMVAMUNE(R) investigational smallpox vaccine to the strategic national stockpile. Payment was received because the company fulfilled a number of significant milestones in the contract. Before year-end Bavarian Nordic expects to invoice two additional milestone payments of $25 million each, bringing the total payment to be received in 2007 on the RFP-3 contract to $100 million.
The National Institutes of Allergy and Infectious Diseases (NIAID) extended an existing contract (RFP-2 awarded in 2004) to initiate a larger Phase II study with IMVAMUNE(R) in people diagnosed with atopic dermatitis. The need for additional clinical safety data in this population has increased due to requirements from the Food and Drug Administration (FDA) to generate data to support an Emergency Use Authorization (EUA) for IMVAMUNE(R). The additional clinical studies will be performed within the contract period, which has been extended until 2010. The value of the contract extension is $15 million.
Consolidated HIV vaccine strategy
Phase II data from the company's MVA HIV nef program showed proof of concept in the ability of the MVA technology to control HIV replication in certain patients. The data also indicates that a broader immune response is desirable in terms of optimizing control of HIV replication. As a result of recommendations from several Scientific Advisory Boards, Bavarian Nordic has therefore re-focused its HIV vaccine development strategy. Data from MVA HIV nef will now be incorporated into the company's MVA-BN(R) HIV multiantigen program which has the potential to meet the success criteria for an effective HIV vaccine. Going forward, Bavarian Nordic's HIV vaccine strategy will focus on the MVA-BN(R) HIV multiantigen program which is in development as both a prophylactic and therapeutic vaccine. A Phase I/II trial, investigating the safety and immunogenicity of MVA-BN(R) HIV multiantigen in HIV-infected patients, will be initiated during first half of 2008.
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