MOUNTAIN VIEW, Calif., July 22, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) ("VIVUS"), which recently began selling the obesity drug Qsymia® (phentermine and topiramate extended-release) capsules CIV in the United States, today announced that its Board of Directors has appointed Michael Astrue to serve as its Chairman and Anthony Zook to serve as its Chief Executive Officer, effective today. Mr. Astrue formerly served as Chief Executive Officer of Transkaryotic Therapies, Chairman of the Massachusetts Biotechnology Council, and Commissioner of Social Security. Mr. Zook formerly served as Executive Vice President, Global Commercial Operations for AstraZeneca and President of Medimmune.
Mr. Astrue said, "We intend to move quickly on our four main goals: 1) expand use of Qsymia through targeted patient and physician education; 2) find the right partner for Qsymia; 3) quickly create a pathway for approval in Europe; and 4) eliminate expenses that are not essential to expanding use of Qsymia. We are thrilled to have an executive of Tony Zook's caliber already pushing hard on these four goals."
Mr. Zook said, "Obesity is a growing disaster for Americans. Aside from its obvious human costs, it creates economic costs due to associated comorbidities such as diabetes, strokes, heart attacks and depression. Our mission is to ensure that at-risk patients and their physicians know about Qsymia and have the information necessary to determine whether Qsymia can help address this devastating condition."
Qsymia is approved in the U.S. 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 (MAOIs); 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.
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. 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. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," "intend," "likely," "may," "plan," "potential," "predict," "opportunity" and "should," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS's Form 10-K for the year ending December 31, 2012, as amended by the Form 10-K/A filed on April 30, 2013 and by the Form 10-K/A filed on June 12, 2013, and periodic reports filed with the SEC.