NOVAVAX Launches Phase I Clinical Trial to Evaluate its Novel Vaccine Against Respiratory Syncytial Virus (RSV)

Vaccine candidate targets world's leading cause of infant death and childhood respiratory disease

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Jan 04, 2011, 08:00 ET

ROCKVILLE, Md., Jan. 4, 2011 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that it has begun patient enrollment in a Phase I clinical trial to assess the safety, immunogenicity and tolerability of a vaccine candidate against respiratory syncytial virus (RSV). In this blinded, placebo-controlled, escalating-dose study of healthy adults 18 to 49 years old, a total of 100 subjects will be allocated to four cohorts and randomized to receive vaccine treatment or saline placebo in a 4:1 ratio. It is expected that interim top-line data from the trial will be available in the third quarter of 2011.

Remarking on this key accomplishment for the Company, Dr. Rahul Singhvi, Novavax's President and CEO, said, "The launch of this trial is timely because there are no vaccines currently approved for RSV disease, which is the most important viral cause of lower respiratory tract infection in infants and children worldwide and is a major cause of respiratory illness in elderly adults. The initiation of the trial for this RSV vaccine candidate marks a key milestone for Novavax, as the Company now has a clinical candidate in a second major disease target in addition to influenza."

Novavax has evaluated its RSV vaccine candidate in well-accepted animal models of toxicity and disease and found it to be safe at all doses tested. Preclinical results have shown induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement and no detection of disease in any of the animals immunized with the vaccine at any dose level tested. Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion protein normally found in the virus.

About Respiratory Syncytial Virus

RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 75,000 to 125,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.

It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high-risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV.

About Novavax

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.

Cautionary Note Regarding Forward-Looking Statements

Statements herein relating to 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: the scope, initiation, rate and progress of our clinical trials; 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 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 as well as other therapeutics aimed at treating or preventing RSV; 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 collaborations; 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 Reports on Form 10-Q for the quarters ended March 31, 2010, June 30, 2010 and 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.

SOURCE Novavax, Inc.