BARDA Continues Novavax' Influenza Vaccine Programs Following In-Process Review
Rockville, MD (GLOBE NEWSWIRE) - Novavax, Inc. (Nasdaq:NVAX) today announced that the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) has completed an In-Process Review (IPR) of Novavax' contract covering the company's recombinant virus-like particle (VLP) vaccine candidates for pandemic and seasonal influenza. The contractually-defined IPR was conducted by a team of U.S. Government experts (BARDA, FDA, NIH and CDC), who provided input on Novavax' progress during the contract base period and plans for further development, including both near-term process development and manufacturing activities and longer-term clinical efforts. BARDA has notified the company that based on the results of the IPR, a milestone decision has been made to continue the contract for both the seasonal and pandemic influenza programs.
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. In the midst of the contract's 3-year base period, valued at $97 million, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. The contract can be extended for an additional 24-month option 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).
About VLPs and Novavax' Vaccine Program
Virus-like particles (VLPs) are self-assembling protein structures that resemble the external structure of viruses, elicit broad and strong antibody and cellular immune responses 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 our cell-culture technology platform combined with single-use bioprocessing technology employed strategically throughout the manufacturing process.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.
Statements herein relating to the future of Novavax and its ongoing development of its influenza vaccine candidates are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2011, and filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties
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SOURCE: Novavax, Inc.