Businessweek

VIVUS, Inc., a biopharmaceutical company, engages in developing and commercializing therapies to address unmet needs in obesity, sleep apnea, diabetes, and sexual health. Qsymia for the Treatment of Obesity The company’s drug, Qsymia (phentermine and topiramate extended-release) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of obesity as 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 approximately 1 weight-related comorbidity, such as hypertension, type 2 diabetes mellitus, or high cholesterol (dyslipidemia). The company offers Qsymia for distribution to eligible patients through the home delivery networks of two certified pharmacies, CVS Pharmacy and Walgreens. The company also expanded the distribution of Qsymia to include the home delivery networks of Express Scripts, Wal-Mart Pharmacy, and for its members only, Kaiser Permanente. In 2012, the company submitted an amendment to its New Drug Application that requests a modification of the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia, which if approved, would allow dispensing through select certified retail pharmacies, to increase access while meeting various requirements of the REMS. Qsymia in Development for Obstructive Sleep Apnea (OSA) The company has completed Phase 2 clinical studies for Qsymia for the treatment of sleep apnea. This Phase 2 study (OB-204) is a single-center, randomized, double-blind, placebo-controlled parallel group trial, including 45 obese men and women (BMI 30 to 40 kg/m2 inclusive), 30 to 65 years of age with OSA. Qsymia in Development for Diabetes The company has completed Phase 2 clinical studies for Qsymia for the treatment of type 2 diabetes. It also studied the effect of Qsymia on well-controlled diabetics as part of its Phase 3 obesity study, CONQUER (OB-303). The results are supportive of the Phase 2 results. Qsymia in Development for Other Indications Qsymia might be helpful in treating other obesity-related diseases, including nonalcoholic steatohepatitis or its precursor, nonalcoholic fatty liver disease, also known as fatty liver disease. Qsymia might also be helpful in treating hyperlipidemia or an elevation of lipids (fats) in the bloodstream. These lipids include cholesterol, cholesterol esters (compounds), phospholipids, and triglycerides. In addition, Qsymia might be helpful in patients with hypertension that do not respond well to antihypertensive medication. STENDRA for the treatment of Erectile Dysfunction (ED) The company’s drug, STENDRA, or avanafil, is an oral PDE5 inhibitor that the company has licensed from Mitsubishi Tanabe Pharma Corporation. STENDRA was approved by the FDA for the treatment of ED in the United States (U.S.) in 2012. The company, through collaboration arrangements with third parties, intends to market and sell STENDRA in the U.S., and if approved, under the trade name SPEDRA in the European Union (EU) and other territories outside the U.S. Other Programs The company has licensed and intends to continue to license from third parties the rights to other investigational drug candidates to treat various diseases and medical conditions. It also sponsors early stage clinical trials at various research institutions and intends to conduct early stage proof of concept studies on its own. Sales and Marketing The company relies on PDI, Inc., a third-party contract sales organization, to assist with hiring sales representatives and the promotion of Qsymia to physicians. Strategy The company’s strategy includes commercializing Qsymia in the U.S.; entering into and supporting a collaboration agreement for the commercialization of STENDRA for the treatment of ED in the U.S.; obtaining regulatory approval for SPEDRA for the treatment of ED in the EU and other territories worldwide; and if approved, entering into and supporting collaboration agreements for the commercialization of SPEDRA for the treatment of ED in the EU and other territories worldwide. Government Regulations The FDA has required the company to perform post-marketing studies for both of its approved products, Qsymia and STENDRA. 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. Patents The company owns or is the licensee of 33 patents and 14 published patent applications in the U.S. and Canada. Research and Development The company incurred $32.1 million in research and development expenses primarily to support the approval efforts for Qsymia and STENDRA in 2012. Competition The company’s competitors include Arena Pharmaceutical; Eisai Inc., the U.S. subsidiary of Eisai Co., Ltd.; Roche; GlaxoSmithKline; and Akrimax Pharmaceuticals, LCL. History VIVUS, Inc. was founded in 1991. The company was incorporated in California in 1991 and reincorporated in Delaware in 1996.