- Vaccine candidates met safety and immunogenicity endpoints in both trials
- Trials' results support further development of vaccine in larger trials -- Adjuvanted candidates, at all doses of antigen tested including 3.75 µg dose, achieved dose-sparing goals with seroconversion and seroprotection rates from 86% to 100% -- Unadjuvanted vaccine candidate, at 45 µg dose, achieved >82% seroconversion and seroprotection in both trials -- Phase 1 results fulfill FDA criteria for accelerated approval; future confirmatory trials planned
- Cross-reactive antibody responses observed for a second strain of A/H5N1
The adjuvanted vaccines induced strong immunogenicity at all antigen doses tested, including the lowest (3.75 µg) dose, based on hemagglutination inhibition assay (HAI) responses against the vaccine virus at day 42.
- 88 to 100% of subjects receiving adjuvanted vaccine at all dose levels demonstrated serum HAI titers ≥40, a seroprotection level believed to be associated with reduced risk of disease.
- 86 to 100% of subjects receiving adjuvanted vaccine at all dose levels demonstrated seroconversion rates with either a four-fold rise in HAI titer or a titer of ≥1:40 from a negative baseline.
- Immune responses would fulfill U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) seroprotection and seroconversion criteria for accelerated approval at the lower bound of the 95% confidence level.
- When tested against another avian A/H5N1 virus different from that in the vaccine, up to 80% of subjects receiving adjuvanted vaccine developed HAI titers ≥40 against the drifted virus.
About NovavaxNovavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com. Forward-Looking Statements Statements herein relating to the future of Novavax and its ongoing development of its vaccine 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. In particular, these statements are subject to the risk that subsequent analyses of trial populations may lead to different (including less favorable) interpretations of the results than the analyses conducted to date or may identify important implications of the study that are not reflected in these statements. Clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the company's view of the data or its implications for the company's pandemic influenza program. In addition, later stage studies may fail to replicate the results described in this press release. We can provide no assurance that we will not encounter problems or delays in clinical development of our pandemic influenza product candidates or that our pandemic influenza product candidates will ever be eligible for accelerated regulatory approval, receive regulatory licensure or be successfully commercialized. Other 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, 2011, and filed with the Securities and Exchange Commission. 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 www.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: Frederick W. Driscoll VP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000