Vivus Inc. (VVUS - Analyst Report) recently announced the launch of its obesity drug, Qsymia, in the US following the US Food and Drug Administration’s (FDA) approval on July 17, 2012. Qsymia is the first FDA approval for a weight-loss drug in 13 years.
The FDA cleared Qsymia as an adjunct to a healthy diet (low on calories) and increased physical activity for chronic weight management in obese (Body Mass Index, or BMI, >30) or overweight (BMI >27) adults suffering from weight-related co-morbidities such as hypertension, type II diabetes mellitus, or dyslipidemia.
Management at Vivus stated that Qsymia is the first approved once daily combination therapy of the drugs phentermine and topiramate to target the obesity market. We note that FDA approval for Qsymia was based on data from two randomized, double-blind, placebo-controlled, phase III studies namely EQUIP and CONQUER.
Approval was granted with a Risk Evaluation and Mitigation Strategy (REMS) and post-marketing requirements. The REMS will keep doctors and pregnant women informed about the risks associated with Qsymia to the fetus.
Vivus had earlier expected to launch Qsymia in the US in the fourth quarter of 2012. Qsymia is currently under review in the EU and the European Medicines Agency (EMA) has scheduled oral hearings with the Committee for Medicinal Products for Human Use (CHMP) this month.
Obesity treatments currently in the market include orlistat, which is sold by Roche Holdings Ltd. (RHHBY - Analyst Report) as Xenical.
Neutral on Vivus
We currently have a Neutral recommendation on Vivus. The stock carries a Zacks #3 Rank (Hold rating) in the short run. We note that rival company Arena Pharmaceuticals Inc. (ARNA - Analyst Report) is preparing for the launch of its obesity drug Belviq along with partner Eisai and Co Ltd. (ESALY - Snapshot Report), which got FDA approval in June 2012. Orexigen Therapeutics, Inc. (OREX - Analyst Report) is also developing a candidate, Contrave, targeting the lucrative obesity market.