Novavax, Inc., a clinical-stage vaccine company, focuses on the discovery, development, and commercialization of recombinant nanoparticle vaccines and adjuvants. The company’s vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate immunologically important proteins. Its product pipeline targets various infectious diseases with vaccine candidates in clinical development for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and the Ebola virus (EBOV). The company has additional pre-clinical stage programs in various infectious diseases, including the Middle East respiratory syndrome coronavirus (MERS). Further, CPL Biologics Private Limited (CPLB), the company’s joint venture company in India, is developing various vaccine candidates that are genetically engineered by the company, including a seasonal influenza VLP (virus-like particle) vaccine candidate that completed enrollment of its Phase 3 clinical trial in India in 2014, and its rabies vaccine that completed its Phase 1/2 clinical trial in India in 2014. The company is also developing proprietary technology for the production of immune stimulating saponin-based adjuvants, through its Swedish wholly-owned subsidiary, Novavax AB. The company’s Matrix adjuvant technology utilizes selected quillaja fractions that, through its manufacturing process form separate matrix structures, to develop modern, multi-purpose immune-modulating adjuvant products for a range of vaccine applications. The company’s major adjuvant for human applications, Matrix-M, has been tested in a Phase 1/2 clinical trial for its pandemic influenza H7N9 vaccine candidate, conducted under its contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS BARDA). The company is testing Matrix-M in conjunction with its EBOV vaccine candidate in a Phase 1 clinical trial. Genocea Biosciences, Inc. has licensed rights to the company’s Matrix technology and is conducting clinical trials with its herpes simplex 2 vaccine candidate using Matrix-M. The company’s joint venture with Cadila Pharmaceuticals Limited (Cadila), CPLB is developing and manufacturing vaccines, biological therapeutics and diagnostics in India. CPLB is owned 20% by the company and 80% by Cadila. CPLB operates a manufacturing facility in India for the production of vaccines. RSV The company is developing its RSV fusion (F) protein nanoparticle vaccine candidate (RSV F vaccine candidate) for the benefit of three susceptible target populations, such as the elderly, infants (receiving protection through antibodies transferred from their mothers who would be immunized during the last trimester of pregnancy), and pediatrics. RSV Elderly Program In October 2014, the company initiated enrollment in a Phase 2 dose-confirmation clinical trial of its RSV F vaccine candidate in 1,600 older adults (>60 years of age). RSV Maternal Immunization Program In September 2014, the company initiated a Phase 2 clinical trial of its RSV F vaccine candidate in healthy women in their third trimester of pregnancy. In November 2014, the company announced that the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (FDA) had granted Fast Track Designation to its RSV F vaccine candidate for protection of infants through maternal immunization. RSV Pediatric Program In November 2014, the company initiated a Phase 1 clinical trial of its RSV F vaccine candidate in 150 healthy children 2 to 6 years of age. CPLB Programs (India) Seasonal Influenza: CPLB completed enrollment of an on-going Phase 3 clinical trial of its seasonal influenza VLP vaccine candidate in 2014. Rabies: CPLB is developing a rabies G protein vaccine candidate that the company genetically engineered and completed enrollment of an ongoing Phase 1/2 clinical trial in India in 2014. In October 2014, CPLB presented clinical results from Stage I of the Phase 1/2 clinical trial. Discovery Programs In 2014, in collaboration with the University of Maryland, School of Medicine, the company published results that showed its investigational vaccine candidates against both MERS and SARS blocked infection in laboratory studies. Although the development of a MERS vaccine candidate remains a pre-clinical program, the company’s MERS vaccine candidate offers a viable option to interested global public health authorities. Suppliers One major vendor is GE Healthcare Company, which supplies disposable components, resins, media and buffers used in the company’s manufacturing process. Patents and Proprietary Rights The company has or 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. The company has a licensing agreement with LG Life Sciences, Ltd. Government Regulations As a U.S. based company, the company focuses on the U.S. regulatory process and the standards imposed by the FDA, International Conference on Harmonisation, and other agencies. The company is also 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 present and potential federal, state or local regulations, including national and local regulations that govern the company’s facility in Sweden. Additionally, for formulations containing controlled substances, the company is subject to Drug Enforcement Act regulations. History Novavax, Inc. was founded in 1987. The company was incorporated in 1987 under the laws of the state of Delaware.
(NVAX:Consolidated Issue Listed on NASDAQ Global Select )
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