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Novavax, Inc. (NVAX) Announces Completion Of In-Process Review

|Includes: Novavax, Inc. (NVAX)

Novavax announced that the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) completed an In-Process Review (IPR) of Novavax' contract covering the company's recombinant virus-like particle (NYSE:VLP) vaccine candidates for pandemic and seasonal influenza. BARDA notified the company that based on the results of the IPR, the contract will be continued for both the seasonal and pandemic influenza programs.

Virus-like particles (VLPs) are self-assembling protein structures that resemble the external structure of viruses, but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable recombinant cell-culture technology. Novavax's VLP-based vaccine candidates are produced more rapidly than egg-based vaccines because of cell-culture technology platform combined with single-use bioprocessing technology employed strategically throughout the manufacturing process.

In March 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant vaccines for the prevention of seasonal and pandemic influenza. The 3-year base period was valued at $97 million. In tandem, Novavax has been developing and testing recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology. The contract can be extended for an additional 24-month period at BARDA's option, with $82 million in additional funding to build on the work Novavax accomplishes during the base period and to support manufacturing scale-up and licensure by the U.S. Food & Drug Administration (FDA).

Novavax is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions. The company is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, and PATH.

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