NOVAVAX Receives FDA Clearance to Launch Phase I RSV Vaccine Clinical Trial
ROCKVILLE, Md., Dec. 16, 2010 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that the company's Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration (FDA) and is no longer on clinical hold. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.
Preclinical studies of Novavax's vaccine candidate to prevent RSV infection were conducted in cotton rats, a well-accepted animal model of RSV infection and disease. Results showed induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement. After the RSV challenge, no detection of disease was observed in any of the animals immunized with the vaccine candidate at any dose level tested. Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion protein normally found in the virus. There is currently no approved vaccine to prevent RSV infection.
"We are excited to advance our vaccine candidate for RSV into clinical testing," said Dr. Rahul Singhvi, President and CEO of Novavax. "This is a significant accomplishment and represents the second major internally discovered vaccine program based on our core platform technologies. RSV is the leading cause of viral death in infants and a common illness in elderly adults. A safe and effective vaccine is especially needed in these populations since RSV infection does not provoke lasting immunity."
About Respiratory Syncytial Virus
RSV is the most commonly identified cause of lower respiratory tract illnesses in infants and young children worldwide. Repeated infections occur throughout life causing moderate to severe cold-like symptoms. More severe lower respiratory tract disease is also seen in elderly adults over age 65 years, similar to the severe illness witnessed in children. It is estimated that RSV infects more than 8.5 million adults annually, including the elderly over age 65 years. This virus is responsible for approximately 900,000 hospitalizations annually in the United States and major European countries. In the United States alone, RSV leads to more than 175,500 hospitalizations annually in high-risk adults resulting in annual medicals costs exceeding $1 billion.
Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide, 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.
Cautionary Note Regarding Forward-Looking Statements
Statements herein relating to future business performance, conditions or strategies and other business matters, including our assessment of the prospects and results of our preclinical studies and clinical trials are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. We caution readers not to place significant reliance on the forward-looking statements contained in this release. 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 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; decisions by regulatory agencies may delay or prevent our development programs or increase the costs of such programs; regulatory approval is needed before any we can initiate clinical trials on our vaccines; 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; RSV is a difficult disease to prevent and there is significant activity by many companies toward the development of a suitable vaccine; 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 and our ability 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; our inability to win any government contracts/grants, including from HHS BARDA, in a timely manner or if at all and other factors referenced herein. 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, including the factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009, as updated by our Quarterly Report on Form 10-Q for the quarter ended September 30, 2010. These forward-looking statements speak only as of the date of this earnings release and Novavax assumes no duty to update such statements.