VIVUS, Inc., a biopharmaceutical company, develops and commercializes therapies to address unmet needs in obesity, sleep apnea, diabetes, and sexual health in the United States and the European Union. Products The company offers two therapies approved by the U.S. Food and Drug Administration (FDA): Qsymia for chronic weight management and STENDRA for erectile dysfunction (ED). STENDRA is also approved by the European Commission, or EC, under the trade name, SPEDRA, for the treatment of ED in the EU. Qsymia Qsymia (phentermine and topiramate extended-release) is an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia). Qsymia incorporates a proprietary formulation combining low doses of active ingredients from two previously approved drugs, phentermine and topiramate. Qsymia is available in approximately 42,000 certified retail pharmacies nationwide, including all of the major pharmacy chains in the country. The company commercializes Qsymia in the U.S. primarily through a dedicated contract sales force, supported by an internal commercial team consisting of sales management, marketing and managed care professionals. STENDRA STENDRA, or avanafil, is an oral phosphodiesterase type 5, or PDE5, inhibitor that the company has licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). STENDRA was approved by the FDA in 2012, for the treatment of ED in the United States. In 2013, the European Commission (EC) adopted the implementing decision granting marketing authorization for SPEDRA (the approved trade name for avanafil in the European Union (EU)) for the treatment of ED in the EU. In 2013, the company entered into an agreement with the Menarini Group, through its subsidiary Berlin-Chemie AG, or Menarini, under which Menarini received an exclusive license to commercialize and promote SPEDRA for the treatment of ED in approximately 40 European countries, including the EU, plus Australia and New Zealand. SPEDRA is commercially available in 23 countries within the Menarini territory. In 2013, the company entered into an agreement with Auxilium Pharmaceuticals, Inc. (Auxilium), under which Auxilium received an exclusive license to commercialize and promote STENDRA in the United States and Canada. The company also entered into a supply agreement with Auxilium, whereby VIVUS would supply Auxilium with STENDRA drug product for commercialization. Auxilium began commercializing STENDRA in the U.S. market in 2013. In January 2015, Auxilium was purchased by Endo International, plc. (Endo). In 2013, the company entered into an agreement with Sanofi under which Sanofi received an exclusive license to commercialize and promote avanafil for therapeutic use in humans in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS), including Russia. Sanofi would be responsible for obtaining regulatory approval in its territories. Sanofi intends to market avanafil under the trade name SPEDRA or STENDRA. Research and Development The company incurred $13.8 million in 2014 in research and development expenses, primarily to support the approval efforts, post-marketing requirements, and clinical programs for Qsymia and STENDRA. Regulations The company’s approved product Qsymia is subject to a REMS program. In addition to laws and regulations enforced by the FDA, the company is subject to regulation under National Institutes of Health guidelines, as well as under the Controlled Substances Act, 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 future federal, state or local laws and regulations, as its research and development may involve the controlled use of hazardous materials, chemicals, viruses and various radioactive compounds. The company participates in the Medicaid Drug Rebate program, established by the Omnibus Budget Reconciliation Act of 1990 and amended by the Veterans Health Care Act of 1992, as well as subsequent legislation. Competition The company’s competitors include Arena Pharmaceutical and Orexigen Therapeutics. History VIVUS, Inc. was founded in 1991. The company was incorporated in California in 1991 and reincorporated in Delaware in 1996.
(VVUS:Consolidated Issue Listed on NASDAQ Global Select )
351 East Evelyn Avenue
Mountain View, CA 94041
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