U.S. FDA Grants Fast Track Designation to Novavax' H7N9 Influenza Virus-Like Particle Vaccine Candidate Adjuvanted With Matrix-M(TM) - Seite 2

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.

About Novavax

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.