VIVUS, Inc. operates as a biopharmaceutical company that develops and commercializes drugs to address the obesity market. Products and Development Programs The company offers two therapies, Qsymia (phentermine and topiramate extended-release) for chronic weight management and STENDRA (Avanafil) for erectile dysfunction, (ED). Qsymia (phentermine and topiramate extended-release) Qsymia 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, or obese patients, or a BMI of 27 or greater, or overweight patients, in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol, or dyslipidemia. Qsymia incorporates a proprietary formulation combining low doses of active ingredients from two previously approved drugs, phentermine and topiramate. As of December 31, 2015, Qsymia is available in approximately 40,000 certified retail pharmacies nationwide. STENDRA STENDRA is an oral phosphodiesterase type 5, inhibitor that the company has licensed from Mitsubishi Tanabe Pharma Corporation. STENDRA was approved by the FDA in April 2012 for the treatment of ED in the United States. In June 2013, the EC adopted a decision granting marketing authorization for SPEDRA, the approved trade name for avanafil in the EU, for the treatment of ED in the EU. The company has an agreement with the Menarini Group, through its subsidiary Berlin Chemie AG, (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, as well as Australia and New Zealand. Menarini commenced its commercialization launch of the product in the EU in early 2014. As of December 31, 2015, SPEDRA is commercially available in 25 countries within the territory granted to Menarini pursuant to the license and commercialization agreement. Research and Development The company incurred $10.1 million in 2015 in research and development expenses. 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 also 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 might 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. Under the Medicaid Drug Rebate program, the company is required to pay a rebate to each state Medicaid program for its covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available to the states for its drugs under Medicaid and Medicare Part B. 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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