MOUNTAIN VIEW, Calif., Feb. 24, 2014 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS), a biopharmaceutical company commercializing Qsymia ® (phentermine and topiramate extended-release) capsules CIV for the treatment of obesity, today provided a business update and reported its financial results for the fourth quarter and year ended December 31, 2013.
- On November 13, 2013, we announced that the United States Patent and Trademark Office had issued U.S. Patent Nos. 8,580,298, covering compositions of Qsymia, and 8,580,299, covering methods for effecting weight loss using Qsymia. The newly issued patents are assigned to VIVUS and are expected to extend patent exclusivity for Qsymia in the U.S. to 2029.
- On November 21, 2013, we announced our support for new clinical practice guidelines developed by the American Heart Association, American College of Cardiology and The Obesity Society, in conjunction with the National Heart, Lung and Blood Institute, urging healthcare providers to take an active role in helping overweight or obese patients achieve and maintain a healthy body weight. The guidelines also state that obesity medication can be considered as an adjunct to lifestyle intervention to help appropriate patients (individuals with BMI ≥30 or BMI ≥27 with at least one obesity-associated comorbid condition) achieve their weight loss goals. A concurrent publication in the Journal of the American Medical Association by researchers from the National Institutes of Health found that medications approved for long-term obesity treatment, when used as an adjunct to lifestyle intervention, lead to an increased likelihood of achieving clinically meaningful weight loss.
- On December 12, 2013, we announced a License and Commercialization Agreement with Sanofi to commercialize avanafil on an exclusive basis in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia. Sanofi will be responsible for obtaining regulatory approval in its territories. Under the terms of the agreement, VIVUS is eligible to receive up to $61 million in upfront payments, regulatory and sales milestones. VIVUS will also receive escalating royalties based on net sales over the life of the agreement.
- On January 2, 2014, we disclosed that we had entered into a Rebate Agreement with CaremarkPCS Health, LLC, a pharmacy benefit manager, under which Qsymia will be available as either a preferred brand (tier-2) or non-preferred brand (tier-3) with copayments ranging from $15.00 to $75.00 for those members of Caremark whose benefit design includes obesity drug coverage. This agreement helped to increase to 43% the percentage of U.S. commercial lives with access to Qsymia at tier-3 or better.
- On January 14, 2014, we announced a collaboration with Aetna, one of the nation's leading diversified health care benefits companies, to integrate Qsymia into a pilot program designed to evaluate the benefits of prescription medication combined with lifestyle support for weight loss. The pilot program is currently being offered to self-insured plan sponsors, and includes outreach to appropriate members and health care providers regarding covered options. It is expected to provide insight regarding impact on health outcomes, workplace productivity and the potential for reductions in medical costs. The program is projected to run through year-end 2014.
- On January 21, 2014, we announced that the U.S. Food and Drug Administration had accepted a supplemental application that proposes to revise the STENDRA™ (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." VIVUS had previously announced positive results from this multicenter, placebo-controlled study designed to assess the efficacy of two dosage strengths of STENDRA approximately 15 minutes after dosing. The PDUFA date for the supplemental filing is September 20, 2014.
"The market for obesity pharmacotherapeutics is developing, and we are making progress in key areas such as physician education, reimbursement coverage and guidelines for treatment," stated Seth H. Z. Fischer, chief executive officer. "While our financial results for this most recent quarter and for 2013 overall were disappointing, we believe in the long-term prospects for this market as we continue our efforts to make Qsymia the drug of choice for patients that are obese or overweight with weight-related medical conditions."
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