U.S. FDA Grants Fast Track Designation to Novavax' H7N9 Influenza Virus-Like Particle Vaccine Candidate Adjuvanted With Matrix-M(TM)

GAITHERSBURG, Md., Oct. 29, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: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' H7N9 Virus-Like Particle Vaccine Candidate (H7N9 VLP) adjuvanted with Matrix-M(TM). The H7N9 VLP is being developed under the company's contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) (Contract No. HHSO100201100012C) for the development of Novavax' recombinant vaccines to address seasonal influenza and influenza strains with pandemic potential. "The FDA's Fast Track Designation for our H7N9 VLP underscores the FDA's recognition of the risk of H7N9 influenza, the lack of any approved vaccines for H7N9 influenza, and the strength of our H7N9 VLP," said Stanley C. Erck, President and CEO of Novavax. "This achievement is another example of the capabilities of our technology platform, the commitment of our people, and the importance of our collaboration with BARDA." In November 2013, Novavax published the first clinical data for any H7N9 Influenza vaccine candidate in The New England Journal of Medicine, which reported positive Phase 1 clinical data from its H7N9 VLP (adjuvanted with a saponin-based adjuvant), in 284 adult subjects, within 180 days of initiating its H7N9 VLP program, an unprecedented achievement in the vaccine industry. The data from this Phase 1 study, along with the positive data released in September 2014 from a Phase 2 trial of 610 subjects, establish Novavax' H7N9 VLP as a leading H7N9 vaccine candidate under development in the industry today. 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 NDA submission. In addition, accelerated approval status (licensure based on a surrogate endpoint) and priority review (6 month review versus standard 10 month review) are potential benefits that may be available to Novavax' H7N9 VLP in the future.