ED Drug Could Support Vivus - Analyst Blog

Vivus Inc. (VVUS) recently reported positive late-stage data on its erectile dysfunction (ED) candidate, avanafil. The phase III trial (TA-314) met all the primary endpoints and also confirmed the long-term safety and efficacy of the potential drug, as observed in the earlier placebo-controlled late-stage trials of avanafil in patients with ED.

The study, which enrolled more than 700 patients, demonstrated that avanafil was well tolerated. Further, 67% of patients taking the drug experienced successful intercourse. Successful intercourse was achieved as early as 15 minutes after taking avanafil.

Vivus plans to complete the new drug application (NDA) filing for avanafil for ED in the second quarter of 2011.

Vivus has a development, licensing and supply agreement with Mitsubishi Pharma Corporation for avanafil. Mitsubishi Pharma is eligible to receive milestone payments on regulatory filing, approval and sale of the drug in the United States and the European Union.

Once approved, avanafil will face intense competition from Pfizer Inc.'s (PFE) Viagra and GlaxoSmithKline plc's (GSK) Levitra.

Neutral on Vivus

We currently have a Neutral recommendation on Vivus, which is supported by a Zacks #3 Rank (short-term Hold rating). We view the positive data on avanafil as a major boost for Vivus. The company recently divested its only marketed drug MUSE (ED) to Meda AB while its lead pipeline candidate, Qnexa (for obesity), received a complete response letter from the US Food and Drug Administration (FDA). The regulatory body has asked for clinical and safety update, labeling change and Risk Evaluation and Mitigation Strategy for Qnexa.

We expect investor focus to remain on Vivus' future course of action for avanafil and Qnexa's approval.

 
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