U.S. FDA Grants Fast Track Designation to Novavax' RSV F-Protein Nanoparticle Vaccine for Protection of Infants via Maternal Immunization
GAITHERSBURG, Md., Nov. 20, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax' RSV F-Protein nanoparticle vaccine candidate (RSV F vaccine) for protection of infants via maternal immunization.
"The FDA's granting of Fast Track designation to our RSV F vaccine for maternal immunization is an important step forward for the program. This achievement reflects the agency's recognition of the importance of this unmet medical need, their support for maternal immunization as an approach to protect infants from this important respiratory pathogen and the potential of our RSV F vaccine," said Stanley C. Erck, President and CEO of Novavax. "Most importantly this designation may allow for an improved timeline to licensure and therefore use of this important vaccine"
Maternal immunization represents a strategy to protect newborn infants through the transfer of maternal antibodies via active transport mechanisms in the placenta, thus providing the infant the benefit of the mother's full repertoire of antibodies at the time of birth. The biology of maternal immunization is well-understood and accepted, and maternal immunization is a recommended practice for several marketed vaccines such as tetanus, pertussis and seasonal influenza. Novavax is one of a number of companies to have initiated a maternal immunization clinical development strategy for pregnant women using a novel vaccine candidate. Novavax initiated the development of its RSV F vaccine for maternal immunization in 2012 and has completed two separate clinical studies in women of childbearing age. In September of this year, the company initiated a groundbreaking study in pregnant women to evaluate the safety and immunogenicity of the RSV F vaccine in pregnant women, to quantify transfer of vaccine-induced RSV antibodies to infants, and to assess the safety and RSV-specific antibody levels in infants through one year and six months of life, respectively.
The Fast Track Drug Development Program was established under the FDA Modernization Act of 1997. A Fast Track designation is intended for products that treat serious or life-threatening diseases or conditions, and that demonstrate the potential to address unmet medical needs for such diseases or conditions. The program is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Specifically, Fast Track designation facilitates meetings to discuss all aspects of development to support licensure and it provides the opportunity to submit sections of a Biologics License Application (BLA) on a rolling basis as data become available, which permits the FDA to review modules of the BLA as they are received instead of waiting for the entire BLA submission. In addition, priority review (6 month review versus standard 10 month review) is a potential benefit that may be available to Novavax' RSV F vaccine in the future.
RSV is a major respiratory pathogen with a significant burden of disease in the very young and in the elderly. In healthy adults, RSV infections are generally mild to moderate in severity, but are typically more severe in infants and young children as well as adults over the age of 60. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. In infants, toddlers and young pre-school and school-age children, RSV infections result in the need for frequent medical care, including ER and office visits and are associated with increased recurrent wheezing that can persist for years. It is also estimated that between 11,000 to 17,000 elderly and high risk adults die of RSV infection or its complications annually in the U.S., and up to 180,000 are hospitalized for serious respiratory symptoms. Currently, there is no approved RSV vaccine available for any of these populations.
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products 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, 2013 filed with the Securities and Exchange Commission (SEC). 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 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.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
David Schull or Andrea Flynn, Ph.D.
Russo Partners, LLC