The company is getting ready to move forward with these next clinical trials for its quadrivalent seasonal influenza vaccine candidate and its pandemic influenza vaccine candidate, both of which are under U.S. INDs. The pandemic study will include use of Matrix-M, Novavax’s proprietary saponin-based adjuvant.
The clinical trials Novavax has planned for 2014 are key steps in completing the company’s goal to move these two vaccine candidates through to licensure. In consideration of the shift of the world’s disease focus from the H5N1 avian influenza strain to the H7N9 avian influenza strain, the company has expanded its pandemic program to include H7N9. The company is particularly pleased regarding BARDA’s interest in the development of both its pandemic vaccine candidates with the Matrix-M adjuvant and its seasonal vaccine program.
Novavax received a contract from BARDA in February 2011 that was valued at up to $179 million. The contract was for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness. Throughout the three-year base period of the contract, which was valued at $97 million, the company 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 part of pandemic preparedness. It is expected that the contract will be extended for an additional 24 months, following satisfaction of established milestones, upon execution by BARDA of an Option One period valued at $79 million in added funding. Milestones under the Option One period would be focused on completing the pathway to product licensures from the FDA, including support for manufacturing scale-up. An additional contract option exists for vaccine production ($3 million).
For more information, visit the Novavax Web site at www.novavax.com
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