VIVUS, Inc. (VVUS) recently announced that the amendment and modification to the Risk Evaluation and Mitigation Strategy (:REMS) of its obesity drug, Qsymia (phentermine and topiramate extended-release) has been approved by the US Food and Drug Administration (:FDA).
As per the modification to the REMS, Qsymia can now be distributed 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. We believe the approval of the amended REMS will increase access to Qsymia and thus boost sales.
We remind investors that Qsymia, VIVUS’ sole marketed product, 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 fourth quarter of 2012 were only $2 million. The uptake has been slow due to the high out-of-pocket cost burden on patients owing to a lack of reimbursement for the product. Although, the company is working on resolving the issue, we believe that it may take some time given that obesity is a new and underdeveloped market.
We remind investors that apart from Qsymia, another weight-loss drug, Arena Pharmaceuticals, Inc. (ARNA) Belviq, also received approval in the US last year. 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 UCB (UCBJF) carrying a Zacks Rank #1 (Strong Buy).
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