ROCKVILLE, Md., June 14 Novavax, Inc. (Nasdaq: NVAX) announced today the appointments of John W. Madsen, Ph.D., as Head of Process and Manufacturing Operations and Steven Pincus, Ph.D., as Head of Analytical and Quality Operations. Dr. Madsen joined Novavax in 2008 as Director of BioProcess Development with responsibility for development of Novavax's seasonal and pandemic influenza vaccines for clinical testing. Dr. Pincus joined Novavax in 2007 as Director of Analytical Development with responsibility for product validation in support of preclinical and clinical studies. They will report to Novavax's CEO, Rahul Singhvi, Sc.D.
"John and Steve are uniquely well-qualified to manage our manufacturing process development, and quality organizations," said Dr. Singhvi. "Under their guidance and support, we have scaled up VLP vaccine manufacturing in large-scale stirred tank bioreactors, doubled our vaccine production capacity in our pilot manufacturing facility, substantially reduced manufacturing costs and advanced plans to commercialize our vaccine candidates. These achievements reflect their leadership skills, as well as the talent and dedication of their teams, and will be critical to our future success."
Previously, Dr. Madsen was Director of Manufacturing for the Vaccine Clinical Materials Program at SAIC-Frederick, Inc., where he was responsible for clinical trials materials manufacturing, and Director of Pharmaceutical Science at Entremed, Inc., where he was responsible for production, technology transfer and scale-up. Before joining Novavax, Dr. Pincus was Senior Director of Virology and Animal Biology at Elusys Therapeutics, where he helped develop monoclonal-based therapeutics to treat infectious diseases, and Senior Research Scientist with Virogenetics, where he developed a number of poxvirus recombinant vaccines and served on project teams that evaluated these candidates in Phase I clinical trials.
About Novavax, Inc.
Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. 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.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding revenue, operating expenses, use of cash, manufacturing developments, and commercial developments 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 or historical experience include, among other things, the following: our ability to progress any product candidates into pre-clinical studies or clinical trials; the scope, initiation, rate and progress of our pre-clinical studies and clinical trials and other research and development activities; clinical trial results; even with positive data from pre-clinical studies or clinical trials, the product candidate may not prove to be safe and efficacious; regulatory approval is needed before any vaccines can be sold in or outside the United States and, to date, no governmental authority has approved any of our vaccine candidates for sale; influenza is seasonal in nature, and if approval or commercial launch after approval is not timely in relation to the influenza season, we may not be able to manufacture or sell our influenza vaccines on terms favorable to us until the next influenza season, if at all; we have not manufactured any of our vaccine candidates at a commercial level; we utilize a unique manufacturing process and the scale-up of that process may prove difficult and/or costly; our dependence on third parties to manufacture and distribute our vaccines; risks associated with conducting business outside of the United States; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; our ability to enter into future collaborations with industry partners and the terms, timing and success of any such collaboration; our ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise. 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 earnings release and Novavax assumes no duty to update such statements.
SOURCE Novavax, Inc.