VIVUS, Inc. (VVUS) 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.
The positive opinion was based on data from three phase III trials REVIVE, REVIVE-Diabetes and REVIVE-RP and a year long safety study.
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 UCB (UCBJF), XOMA Corporation (XOMA) and Athersys Inc. (ATHX) appear to be more attractive. All the three stocks carry a Zacks Rank #1 (Strong Buy).
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