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Vivus Announces 2012 Medical Societal Meeting Schedule for Qsymia (Phentermine and Topiramate Extended-Release) CIV(October 02, 2012)
MOUNTAIN VIEW, Calif., Oct. 2, 2012 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced the Qsymia™ medical societal meeting schedule upcoming in 2012. The VIVUS presence and Qsymia awareness at these key meetings include scientific presentations, continuing medical education or CME support and/or promotional product theater.
"The Qsymia Fall schedule will build on the success from The Obesity Society (TOS) meeting recently held in San Antonio. The Qsymia launch coincided with TOS and the response from the attendees was positive. Qsymia was featured in several presentations, and traffic through the exhibit booth was very high," stated Michael Miller, SVP and Chief Commercial Officer of VIVUS. "Healthcare provider education and awareness of Qsymia are areas of primary focus during this initial launch period. Our participation in these upcoming medical meetings will further this cause beyond the obesity specialists."
Upcoming conference schedule:
Academy of Managed Care Pharmacies
Oct. 3-5, 2012
American College of Nurse Practitioners
Oct. 3-7, 2012
7th Annual Obesity Summit
Oct. 4-5, 2012
Osteopathic Medical Conference &
Oct 7-11, 2012
Cardiometabolic Health Congress
Oct. 10-13, 2012
American Academy of Family Physicians
Oct. 16-20, 2012
American Society of Bariatric Physicians
Oct. 24-28, 2012
Obesity Action Coalition
Oct. 25-28, 2012
American Heart Association
Nov. 3-7, 2012
Qsymia is available only through certified mail order pharmacies that are part of the Qsymia Home Delivery Network, including CVS Pharmacy and Walgreens.
Qsymia 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.
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 U.S., Europe and other world markets. Qsymia is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. 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. These factors include, but are not limited to, our lack of commercial experience with Qsymia in the U.S.; the timing of initiation and completion of the clinical studies required as part of the approval of Qsymia by the United States Food and Drug Administration, or FDA; the response from the FDA to the data that VIVUS will submit relating to post-approval clinical studies; the impact of the indicated uses and contraindications contained in the Qsymia label and the REMS requirements; the impact of distribution of Qsymia through a certified pharmacy network; that we may be required to provide further analysis of previously submitted clinical trial data; our response to questions and requests for additional information including additional pre-clinical or clinical studies from the European Medicines Agency, or EMA, and the Committee for Medicinal Products for Human Use, or CHMP, for the Marketing Authorization Application, or MAA, for Qsymia; our ability to successfully commercialize or establish a marketing partnership for avanafil, which will be marketed in the U.S. under the name STENDRA™, or our partner's ability to obtain and maintain regulatory approval to manufacture and adequately supply avanafil to meet demand; our history of losses and variable quarterly results; substantial competition; risks related to the failure to protect our intellectual property and litigation in which we may become involved; uncertainties of government or third party payer reimbursement; our reliance on sole source suppliers; our limited sales and marketing and manufacturing experience; our reliance on third parties and our collaborative partners; our failure to continue to develop innovative investigational drug candidates and drugs; risks related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; our ability to demonstrate through clinical testing the safety and effectiveness of our investigational drug candidates; the timing of initiation and completion of clinical trials and submissions to foreign authorities; the volatility and liquidity of the financial markets; our liquidity and capital resources; and our expected future revenues, operations and expenditures. As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and commercialization of new products. There are no guarantees that our response to the CHMP's 180-day list of outstanding issues and subsequent meetings and communications will be sufficient to satisfy the CHMP's safety concerns regarding Qsymia, that the foreign authorities will not require us to conduct any additional prospective studies or retrospective observational studies, or that any product will receive foreign regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ending December 31, 2011, and periodic reports filed with the Securities and Exchange Commission.
CONTACT: VIVUS, Inc.
Timothy E. Morris
Chief Financial Officer
The Trout Group
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