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Last $7.95 USD
Change Today +0.22 / 2.85%
Volume 3.5M
NVAX On Other Exchanges
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NASDAQ GS
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As of 8:10 PM 05/1/15 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

20 Firstfield Road

Gaithersburg, MD 20878

United States

Phone: 240-268-2000

Fax:

Novavax, Inc., a clinical-stage biopharmaceutical company, focuses on discovering, developing, and commercializing recombinant protein nanoparticle vaccines and adjuvants. The company’s vaccine technology platform is based on proprietary recombinant nanoparticle vaccine technology that includes both virus-like particles (VLPs) and protein nanoparticle vaccine candidates. Its vaccine product pipeline targets various infectious diseases with candidates in clinical development for respiratory syncytial virus (RSV), seasonal influenza, and pandemic influenza. Further, CPL Biologics Private Limited, the company’s joint venture company in India, is developing various vaccine candidates. These include its seasonal and pandemic influenza vaccine candidates that have completed Phase 1/2 clinical trials in India in 2012, and its rabies vaccine that began a Phase 1/2 clinical trial in India in early 2014. RSV The company is developing a vaccine candidate to prevent RSV and is looking at three susceptible target populations: infants (receiving protection through antibodies transferred from their mothers who would be immunized during the last trimester of pregnancy), the elderly and young children. RSV Maternal Immunization Program In 2013, the company announced top-line data from a Phase 2 dose-ranging clinical trial in women of childbearing age that were similar to, or exceeded, immune responses seen in its first Phase 1 clinical trial. RSV Elderly Program In 2013, the company announced top-line data from the Phase 1 clinical trial in the elderly that was initiated in 2012. Seasonal Influenza Program: The company’s vaccine candidate met the U.S. Food and Drug Administration accelerated approval seroprotection rates criterion for all four viral strains. Pandemic Influenza Program: In 2013, the company initiated manufacturing of a new monovalent influenza vaccine candidate against the prototype A(H7N9) strain. In February 2014, the company modified its contract with the Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS BARDA) to focus its development of a monovalent pandemic influenza vaccine against the A(H7N9) strain with a Phase 1/2 clinical trial with its H7N9 candidate and its Matrix-MTM adjuvant, which began in 2014 and for which, top-line data is scheduled to be released in the second half of 2014; however, HHS BARDA has also indicated that its H5N1 vaccine program remains a viable development opportunity under its contract. HHS BARDA Contract for Recombinant Influenza Vaccines Although HHS BARDA originally directed the company to develop its monovalent pandemic influenza vaccine against the A(H5N1) strain, after achieving positive results with its H7N9 vaccine candidate last year, HHS BARDA has directed the company to develop its monovalent pandemic influenza vaccine against the A(H7N9) strain. Nevertheless, its H5N1 vaccine program remains a viable development opportunity under the contract. Suppliers Two of the company’s major suppliers are GE Healthcare Company (GEHC), which supplies disposable components used in its manufacturing process; and Xcellerex, Inc., which supplies its single-use bioreactor production system and related supplies. Competition The company competes with Sanofi Pasteur, SA; MedImmune, LLC (a subsidiary of AstraZeneca PLC); GlaxoSmithKline plc; Novartis, Inc.; Merck & Co., Inc.; and Protein Sciences Corporation. Patent Rights and Licenses The company has intellectual property (patents, licenses, know-how) related to its vaccines, manufacturing process and other technologies. The company has rights to approximately 100 U.S. patents and corresponding foreign patents and patent applications relating to vaccines and biologics. Its core vaccine-related intellectual property extends beyond the year 2025. The company has a non-exclusive license agreement with Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. to obtain rights to a family of patents and patent applications covering VLP technology for use in human vaccines in certain fields, with expected patent expiration in early 2022. Government Regulations As a U.S. based company, the company focuses on the U.S. regulatory process and the standards imposed by the U.S. Food and Drug Administration and other agencies. The company is subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other federal, state or local regulations. History Novavax, Inc. was founded in 1987. The company was incorporated in 1987 under the laws of the state of Delaware.

 

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