) 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).
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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
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
Arena Pharmaceuticals, Inc.
) Belviq, also received approval in the US last year.
Orexigen Therapeutics, Inc.
) 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
) carrying a Zacks Rank #1 (Strong Buy).