ROCKVILLE, Md., March 3, 2011 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that Maryland State Governor Martin O'Malley will visit the company's headquarters in Rockville, Maryland, on Monday, March 7, to celebrate the recently announced contract valued at up to $179 million. The Office of Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) awarded the contract to Novavax for the advanced clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza.
"The Governor's recognition of our award is a tremendous honor to the employees of Novavax and an acknowledgement of the importance of both this contract award and the company's contribution to the State of Maryland," said Novavax's President and CEO Dr. Rahul Singhvi. "We are thrilled to formally celebrate our partnership with BARDA, which will accelerate the development of a recombinant influenza vaccine solution and help the U.S. government prepare for potential influenza pandemics."
During the contract's 3-year base period, valued at $97 million, Novavax will continue its development of its novel, clinical-stage, recombinant virus-like-particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology and pandemic preparedness. The contract has a 24-month option period 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 and Drug Administration (FDA).
"On behalf of all Marylanders, I am so proud to congratulate Novavax on their federal award," said Governor O'Malley. "Their leadership in innovation and discovery is exactly what we need to compete and win in the new economy and their contributions are proof of what biotechnology and life sciences can mean to the future of our State and our nation. I'd like to thank Dr. Singhvi and all of the Novavax employees for their commitment and dedication to this important healing and lifesaving work."
Novavax is currently developing vaccines to prevent pandemic (H5N1) and seasonal influenza using its novel VLP technology, which enables more rapid vaccine production than traditional egg-based methods. The BARDA contract award follows the August 2010 Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza by the President's Council of Advisors on Science and Technology, which analyzed current influenza vaccine production processes and identified ways the U.S. federal government could support improvements in relevant technologies to reduce the time required to supply vaccine to the U.S. population when the next influenza pandemic occurs.
About VLPs and Novavax's Vaccine Program
Virus-like particles (VLPs) mimic 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 cell-culture technology. Novavax's VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company's proprietary virus-like particles (VLPs) technology and single-use bioprocessing production system enables rapid vaccine development and production where and when it's needed, worldwide. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.
Forward Looking Statements
Statements herein relating to the award by HHS BARDA of a contract for the advanced development of recombinant influenza vaccine, the development of our vaccine products, vaccine safety and efficacy, and the ability to quickly produce a vaccine product during an influenza pandemic and other future financial or business performance or matters are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements include: HHS BARDA may or may not award any option period funding to Novavax; the Company has not yet manufactured, or relied on third parties to manufacture, any vaccines at a commercial scale; historical and current results may not be predictive of future trial results for the seasonal vaccine or any other vaccine that we are developing or may develop; further testing is required before regulatory approval can be applied for and the FDA may not approve a vaccine even if the results are similar or better than the results reported to date; uncertainties related to the initiation, enrollment, progress and completion of clinical trials; and whether Novavax could repeat the 12-week production of a vaccine in a future pandemic could depend on many factors outside the company's control including the virus itself. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.
|SOURCE Novavax, Inc.|
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