) is highly dependent on Qsymia (proposed trade name: Qsiva in
the EU) for its long-term growth. The drug was launched in the
U.S. in Sep 2012. The U.S. Food and Drug Administration (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.
However, Qsymia has performed disappointingly since launch.
Qsymia revenues in the second quarter of 2013 were $5.5 million
as compared to $4.1 million recorded in the first quarter of
The company is trying to boost revenues by gaining approval in
Europe. VIVUS has submitted a request for scientific advice
related to the use of interim data from the AQCLAIM
cardiovascular outcomes trial to support the resubmission of the
marketing application, to the European Medicines Agency. VIVUS
expects to start patient enrolment for the study in the first
quarter of 2014.
Apart from this, Qsymia has also received FDA approval for an
amendment and modification to the Risk Evaluation and Mitigation
Strategy (REMS). 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. The company
announced retail availability on Jul 1, 2013.
We remind investors that apart from Qsymia, another weight-loss
Arena Pharmaceuticals, Inc.
) Belviq, received approval in the U.S. last year. Belviq was
launched in the U.S. in Jun 2013.
Orexigen Therapeutics, Inc.
) is also developing a candidate, Contrave, targeting the
lucrative obesity market.
Apart from Qsymia, VIVUS' portfolio consists of another approved
product, Stendra, for erectile dysfunction (ED). The drug
is approved in the U.S. (Apr 2012) and the EU (Jun 2013).
VIVUS, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Biopharma companies that currently look
) with a Zacks Rank #2 (Buy).
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