MOUNTAIN VIEW, Calif., Dec. 20, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that Express Scripts, among the country's largest Pharmacy Benefit Managers (PBMs), has added Qsymia™ to its national pharmacy formularies, allowing for coverage where available by benefit design of the first new FDA-approved medication commercially available in the U.S. in over a decade for the treatment of chronic weight management.
Express Scripts provides the formulary design, pharmaceutical contract management and claims processing for some of the largest payers and employers in the U.S.
Qsymia has been added as a standard benefit option to Express Scripts' national formulary in a tier-3 position with a prior authorization. Under the Express Scripts plan, participating patients will now pay an estimated $50.00 to $60.00 for their co-payment for a monthly prescription of Qsymia, approximately one-third of the retail price.
"This is a major step forward in expanding access to an important new medication for a population that needs effective pharmacological interventions," said Peter Tam, President of VIVUS. "Obesity has a devastating impact on our society and contributes significantly to comorbidities such as high blood pressure, type 2 diabetes, or high cholesterol."
Qsymia is available only through mail order from the Qsymia Certified Home Delivery Pharmacy Network, including CVS Pharmacy, Express Scripts, Walgreens and Walmart, as part of the Qsymia Risk Evaluation and Mitigation Strategy (REMS) program. Contact information for the certified pharmacies can be found on www.Qsymia.com and www.QsymiaREMS.com.
Qsymia was made available September 17, 2012 and is the first FDA-approved once daily combination therapy — and the first new medication available in 13 years — for the treatment of obesity.
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 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 limited 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; whether or not the FDA approves our amendment to the REMS for Qsymia, which, if approved, would allow dispensing through select retail pharmacies to increase access while meeting all requirements of the REMS; that we may be required to provide further analysis of previously submitted clinical trial data; our appeal of the negative opinion of the European Medicines Agency's, or EMA, 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 the commercialization of new products. There are no guarantees that the product will receive regulatory approval outside the United States 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's Form 10-K for the year ending December 31, 2011, and periodic reports filed with the Securities and Exchange Commission.
SOURCE VIVUS, Inc.