Quadrivalent Seasonal Influenza Clinical Trial to start in 1Q2014
Pandemic Influenza Clinical Trial to start in the U.S. in 1H2014
Proprietary Adjuvant Matrix-M to be used in the Pandemic Clinical Trial
ROCKVILLE, Md., Sept. 24, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc.(Nasdaq:NVAX) a clinical-stage vaccine company, announced today that it is finalizing details on costs and timelines for their next round of clinical studies with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) following successful completion of process improvement studies. Novavax is preparing to move forward with these next clinical trials for its quadrivalent seasonal influenza vaccine candidate and its pandemic influenza vaccine candidate, both under U.S. INDs. The pandemic study will include the use of Novavax' proprietary saponin-based adjuvant, Matrix-M™.
"Novavax is committed to moving these two vaccine candidates through to licensure. The clinical trials we have planned for 2014 are important steps in the completion of that goal," said Stanley C. Erck, President and Chief Executive Officer, "Given the shift in the global disease focus from the H5N1 avian influenza strain to the H7N9 avian influenza strain we have expanded our pandemic program to include H7N9. We are especially pleased with BARDA's interest in the development of both of our pandemic vaccine candidates with the Matrix-M adjuvant, along with our seasonal vaccine program."
About the Novavax BARDA Contract
In February 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness. Throughout the contract's 3-year base period, valued at $97 million, 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. Upon satisfaction of established milestones, the contract can expect to be extended for an additional 24 months, upon execution by BARDA of an Option One period, valued at $79 million in additional funding. The milestones under the Option One period would focus on completion of the pathway to product licensures from the U.S. Food and Drug Administration (FDA), including support for manufacturing scale-up. There is an additional contract option for vaccine production ($3 million).
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. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. 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, 2012,and Form 10-Q for the period ended June 30, 2013, both 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.
CONTACT: Barclay Phillips
SVP, Chief Financial Officer and Treasurer