) 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
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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
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
Arena Pharmaceuticals, Inc.
) Belviq, also received approval in the US last year. Belviq was
launched in the US last month.
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).