) recently announced the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) has
recommended the approval of its drug, Spedra (avanafil) for the
treatment of erectile dysfunction (ED). The positive opinion by
the CHMP will be reviewed by the European Commission, which
should issue a final decision in approximately two months.
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The positive opinion was based on data from three phase III
trials REVIVE, REVIVE-Diabetes and REVIVE-RP and a year long
In the US, avanafil was approved by the US Food and Drug
Administration (FDA) in Apr 2012 under the trade name Stendra for
ED. The company is looking for a partner in the US.
The other FDA approved drug at VIVUS is Qsymia. 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.
VIVUS, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). Biopharma stocks like
) appear to be more attractive. All the three stocks carry a
Zacks Rank #1 (Strong Buy).