NOVAVAX Awarded HHS-BARDA Contract Valued at up to $179 Million to Develop Pandemic and Seasonal Influenza Vaccines for U.S. Government Using Recombinant VLP Technology
Contract Includes $97 Million 3-year Base Period and $82 Million 2-year Option Period
Base Period Will Fund Seasonal Influenza Vaccine through Phase 3 and Potential FDA Licensure; Pandemic Influenza Vaccine Candidates through Phase 1/2 Clinical Trials
Includes Development of Manufacturing Plan to Establish a U.S.-based Facility with Surge Manufacturing Capacity of 50 Million Doses within Six Months of Influenza Pandemic
Company to Hold Investor Conference Call 10:00 am ET Today
ROCKVILLE, Md. - (March 1, 2011) - Novavax, Inc. (Nasdaq: NVAX) announced today that it has been awarded a contract valued at up to $179 million by the Office of Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) for the advanced clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza. During the contract's 3-year base period, valued at $97 million, Novavax will continue to develop and manufacture its novel, clinical-stage, recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology and pandemic preparedness. The contract could be extended for an additional 24-month option period with $82 million in additional funding to build on the work Novavax accomplishes during the base period and to support manufacturing scale-up and licensure by the U.S. Food & Drug Administration (FDA).
During the contract's base period, funded activities would include:
three (3) clinical trials utilizing Novavax's pandemic influenza VLP vaccine candidate with adjuvants (including Novavax's proprietary adjuvant);
Phase 2 dose-ranging trial and Phase 3 registration trial utilizing Novavax's seasonal influenza VLP vaccine candidate; and
development of a manufacturing facility plan that has the capability to produce finished vaccine within twelve (12) weeks and at least 50 million doses within six (6) months of an influenza pandemic declaration.
Novavax's manufacturing facility plan will outline the design, construction, commissioning, qualification and validation of such a U.S.-based facility to produce recombinant seasonal and pandemic vaccines. Additional funded base period activities include vaccine product characterization, process development and scale-up of recombinant vaccine manufacturing including consistency lot manufacturing and lot-release assay development in support of the Phase 3 trial.
Conference Call Information
Novavax's senior management will host a conference call at 10:00 am Eastern time today to discuss this announcement. You may listen to the call on Novavax's website at www.novavax.com under "Investor/Events" or by telephone at 1-877-212-6076 (domestic) or 1-707-287-9331 (international). To access a replay of the conference call, dial 1-800-642-1687 (domestic) or 1-706-645-9291 (international) and enter pass code 48683057.
About VLPs and Novavax's Vaccine Program
Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax's VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company's proprietary virus-like particles (VLPs) technology and single-use bioprocessing system enables rapid vaccine development and production where and when it's needed, worldwide. 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.