VIVUS Announces Settlement with Dr. Reddy's Laboratories on Qsymia(R) Patent Litigation
CAMPBELL, CA--(Marketwired - August 30, 2017) - VIVUS, Inc. (VVUS) announced today that it has entered into a settlement agreement with Dr. Reddy's Laboratories, S.A. and Dr. Reddy's Laboratories, Inc. (Dr. Reddy's) resolving patent litigation related to Qsymia® (phentermine and topiramate extended-release) capsules CIV. The litigation, which has been pending in the U.S. District Court for the District of New Jersey since 2015, resulted from the submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration seeking approval to market generic versions of Qsymia. The settlement agreement permits Dr. Reddy's to begin selling a generic version of Qsymia on June 1, 2025, or earlier under certain circumstances. In the event of a launch earlier than June 1, 2025, VIVUS will receive a royalty on sales of the generic version of Qsymia.
This settlement with Dr. Reddy's concludes all patent litigation brought by VIVUS against generic pharmaceutical companies that have filed ANDAs seeking approval to market generic versions of Qsymia®. As required by law, VIVUS and Dr. Reddy's will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
"We are pleased to have concluded all patent litigation that we have brought in the context of the generic availability of Qsymia," said Seth H. Z. Fischer, VIVUS' Chief Executive Officer. "We believe that these settlements underscore the strength of our intellectual property and demonstrate our commitment to defending our existing patents for all our products and technologies. We expect to expand our intellectual property estate as we continue to innovate new treatments that improve and extend the lives of patients with serious unmet medical needs."
About Qsymia
Qsymia is approved in the United States 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.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
About VIVUS
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the company, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to potential change in our business strategy to enhance long-term stockholder value; risks and uncertainties related to our ability to protect our intellectual property and litigation in which we are involved or may become involved; and risks and uncertainties related to our ability to continue to identify, acquire and develop innovative investigational drug candidates and drugs. These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2016 as filed on March 8, 2017 and as amended by the Form 10-K/A filed on April 26, 2017, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.
