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VIVUS Mails Letter To Stockholders Providing Business Update

Stocks in this article: VVUS

In mid-April, VIVUS successfully achieved another major milestone in our ongoing commercialization efforts with FDA approval of our Risk Evaluation and Mitigation Strategy (REMS) modification for Qsymia. This approval will allow patients to access Qsymia at certified retail pharmacies nationwide. Since the approval, we have been busy executing the implementation plan to ensure certified retail pharmacy availability of Qsymia by mid-July 2013.

VIVUS has built sustainable momentum with cardiometabolic specialists and accomplished several key milestones that set the foundation for the medical obesity treatment category. One of our most important goals for 2013 is the expansion of both access and reimbursement for Qsymia, the only FDA-approved oral medication shown to achieve more than 10% average weight loss in obese patients.

VIVUS HAS ACHIEVED IMPORTANT MILESTONES FOR QSYMIA AND STENDRA

In 2012, despite a difficult FDA environment, we successfully developed and achieved FDA approvals for Qsymia and STENDRAâ„¢ (avanafil).

In the case of Qsymia, the approval came with a REMS and Elements To Assure Safe Use including allowing distribution only by certified mail order pharmacies. The recent FDA approval of our amendment and modification to the REMS for Qsymia is an important accomplishment in our ongoing commercialization strategy. This critical milestone indicates broader and improved patient access to Qsymia through thousands of certified retail pharmacies, and significantly simplifies the prescribing and dispensing process for healthcare providers.

Both Qsymia and STENDRA were internally developed and VIVUS has maintained full ownership of these assets, providing us with the flexibility to pursue a full range of options to maximize stockholder value.

VIVUS HAS SUCCESSFULLY EXECUTED THE INITIAL PHASE OF ITS COMMERCIAL STRATEGY

Since the approval of Qsymia, our team has hit the ground running. Under the oversight of our Board, VIVUS management has implemented a clear, consistent and ongoing strategy to build a successful Qsymia franchise. We have proactively educated healthcare providers (specifically, cardiometabolic specialists and other key opinion leaders) about obesity as a chronic medical condition requiring treatment and educated these thought leaders about Qsymia's favorable efficacy and safety profile. As of March 31, 2013, we have made nearly 90,000 calls on 25,000 targeted healthcare providers, and since launch we have trained more than 300 physician speakers who have conducted approximately 800 peer-to-peer programs for more than 9,300 participating attendee physicians. We also have conducted continuing medical education programs for over 13,000 healthcare providers. Additionally, as of March 31, 2013, more than 39,500 unique patients have been dispensed a prescription for Qsymia since launch.

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