VIVUS, Inc., a biopharmaceutical company commercializing Qsymia capsules CIV for the treatment of obesity, has acquired a group of patents from Janssen Pharmaceuticals, Inc. covering uses of topiramate as monotherapy and in combination with other pharmaceutical agents to treat a variety of medical conditions.
Janssen has agreed to dismiss the lawsuit it brought against VIVUS on August 22, 2014 in the US District Court for the District of Delaware (Case No. 1:14-cv-01088 UNA).
The patents acquired by VIVUS -- including US 6,071,537 (Shank), US 6,362,220 (Cottrell) and others -- are directed to methods of using topiramate to treat obesity, lower blood pressure and lipid parameters, and reduce blood glucose. VIVUS also assumed all rights under Janssen's license for US 6,323,236 (McElroy), owned by the University of Cincinnati, and will be responsible for all future financial obligations under that license. The McElroy patent is directed to methods of using topiramate to treat impulse control disorders.
VIVUS will pay a one-time upfront fee and a royalty to Janssen on Qsymia product sales for an assignment of these topiramate-related patents owned by Janssen. VIVUS has an option to buy out the royalty for a predetermined amount.
Qsymia is approved in the US and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.