VIVUS, Inc. (VVUS) recently announced that its obesity drug, Qsymia, is now available in approximately 8,000 certified retail pharmacies in the US. Initial availably was announced earlier than its mid-July 2013 schedule. VIVUS is focused on increasing the access to Qsymia and plans to continue to add pharmacies to its Qsymia distribution network.
We remind investors that in Apr 2013, VIVUS’ amendment and modification to the Risk Evaluation and Mitigation Strategy (:REMS) of Qsymia was approved by the US Food and Drug Administration (:FDA). The modification to the REMS allowed VIVUS to distribute Qsymia through certified retail pharmacies apart from the existing certified mail-order pharmacy network. VIVUS had launched Qsymia through some of the leading home delivery networks.
VIVUS’ sole marketed product, Qsymia, was launched in Sep 2012. The FDA cleared Qsymia in Jul 2012 as an adjunct to a healthy diet (low on calories) and increased physical activity for chronic weight management in obese (Body Mass Index, or BMI - 30 or more) or overweight (BMI - 27 or more) adults suffering from at least one weight-related co-morbid condition.
Qsymia revenues in the first quarter of 2013 were only $4.1 million. We believe that increased availability of Qsymia will aid sales. However reimbursement remains a major concern. The high out-of-pocket cost burden on patients owing to a lack of reimbursement for Qsymia has been limiting the uptake of the product. The company has introduced two cost savings programs to address the issue.
We remind investors that apart from Qsymia, another weight-loss drug, Arena Pharmaceuticals, Inc.’s (ARNA) Belviq, also received approval in the US last year. Belviq was launched in the US last month. Orexigen Therapeutics, Inc. (OREX) is also developing a candidate, Contrave, targeting the lucrative obesity market.
VIVUS, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Biopharma stocks that currently look attractive include companies like Targacept, Inc. (TRGT), carrying a Zacks Rank #1 (Strong Buy).
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