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TheStreet Open House

VIVUS Mails Letter To Stockholders Providing Business Update

Stock quotes in this article: VVUS

WITH EXPANDED ACCESS AND REIMBURSEMENT, WE BELIEVE THAT QSYMIA CAN BECOME A TOP-SELLING DRUG

Providing retail access to Qsymia through certified pharmacies, the next step in our commercialization strategy, is well underway and is expected to be introduced by mid-July 2013. This phase of our strategy includes the certification of thousands of retail pharmacies, stocking of Qsymia in the distribution system and the continued notification of the product's availability to prescribers and patients. Once completed, healthcare providers will be able to send patients directly to certified pharmacies to fill their Qsymia prescriptions, which will significantly reduce time between provider-patient discussions and initiation of therapy. We believe that the proven clinical efficacy and broader access for patients through certified retail pharmacies will result in significant prescription growth, and will help Qsymia realize its potential to become a top-selling drug.

We have made significant progress in our reimbursement efforts. Qsymia is currently available on the Express Scripts national formulary, and in April 2013, we successfully entered into an agreement with Medco Health Solutions (Medco) whereby Qsymia has been added to the Medco national formulary. Under the agreement, patients covered by Medco will have a co-payment of approximately $50.00 to $60.00 for a monthly prescription of Qsymia.  These formulary agreements with the largest Pharmacy Benefit Managers (PBM) in the U.S. should significantly reduce out-of-pocket costs for many patients who are prescribed Qsymia and should support continued patient and clinician adoption. The Veterans Administration National PBM recently published a Criteria for Use for Qsymia. Now veterans whose body mass index (BMI) and other health criteria fall within the Qsymia label can access Qsymia for a co-pay of $9.00. Clearly, decision makers at Medco, Express Scripts and the VA have taken significant steps to address medical obesity within their membership.

We also were pleased to see published in Health Economics Review (Feb-2013) a study demonstrating that effective medical treatment providing 10% to 15% weight loss can lead to significant reductions in Medicare spending by reversing or mitigating health consequences such as type 2 diabetes, hypertension and dyslipidemia in obese or overweight patients. These types of data are critical to potential payors and public policy makers as they demonstrate the positive impact that an effective weight loss therapeutic drug can have on healthcare costs. We believe that the medical obesity category is emerging and the drug treatment rate for this indication will increase. For example, the American Association of Clinical Endocrinologists has incorporated obesity management and FDA-approved anti-obesity medications - along with lifestyle modifications - into a new comprehensive treatment algorithm for individuals with prediabetes, diabetes, dyslipidemia and hypertension.

WE REMAIN COMMITTED TO QSIVA™ APPROVAL IN EUROPE AND INTEND TO FILE IN OTHER  TERRITORIES AROUND THE WORLD

As evidenced by the recent withdrawal of a competitive product's marketing authorization application (MAA) from the centralized procedure in Europe, the regulatory environment in Europe remains challenging for new obesity therapies. For us, Europe remains an important opportunity. We are currently working with our European team of clinical, legal, and regulatory advisors to evaluate and confirm our regulatory strategy in Europe, which may include a near-term filing of an MAA under the decentralized procedure in selected countries. Longer-term, we may utilize interim data from our Cardiovascular Outcomes Trial (CVOT) to file in the remainder of the countries.

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