Gaithersburg, MD (October 29, 2014)–/GlobeNewswire/-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™. 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.
About H7N9 Avian Influenza
Following recognition of the first human infections with H7N9 avian-origin influenza and their attendant severity in March 2013, public health officials from around the world called for immediate and preemptive development of surveillance, diagnostic and clinical intervention tools in the event that the H7N9 virus becomes transmissible among humans. According to Dr. Keiji Fukuda, Assistant Director-General for Health, Security and Environment at the WHO, there is high concern over potential for H7N9 to gain sustainable person-to-person transmissibility. Dr. Fukada noted that over a two-month period in China, as many H7N9 cases occurred as H5N1 cases occurring over a 10 year period. Additionally, molecular genetic changes occurred, suggesting adaptation of the virus to humans. After a quiescent period during the 2014 summer months, several new human cases of H7N9 disease have been reported since the beginning of October 2014, prompting concerns and expectations over the virus reemerging in human populations in the coming winter season.
About the Novavax HHS-BARDA Contract
The contract was originally awarded in February 2011, with funding of up to $97 million over an initial base period ending in February 2014, and subsequently extended to September 2014. Through the second quarter of 2014, Novavax recognized approximately $65 million in revenue since the inception of the contract. During the contract's 43-month base period, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. In September 2014, BARDA exercised the option period of the contract and extended the period of performance through September 2016. The milestones under the option period are focused on activities leading up to initiation of Phase 3 clinical trials. Through the second quarter of 2014, the company recognized approximately $65 million in revenue since the inception of the contract.
Novavax, Inc. (Nasdaq: 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.
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