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VIVUS and Auxilium Announce Stendra Label Expansion

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VIVUS, Inc. (VVUS - Free Report) and Auxilium Pharmaceuticals, Inc. announced that the FDA has approved their erectile dysfunction (ED) drug, Stendra’s (EU trade name: Spedra) supplemental new drug application (sNDA) to include 15 minutes onset of action. VIVUS shares soared 12.4% on the news.

As per the newly approved label, Stendra can be taken as early as approximately 15 minutes before sexual activity. The previously approved prescribing information recommended administration of Stendra approximately 30 minutes before.

Stendra, a phosphodiesterase type 5 (PDE5) inhibitor, received marketing approval in the U.S. in Apr 2012 and the EU in Jun 2013. VIVUS has collaborated for the drug with privately -held Italian pharmaceutical company, Menarini (more than 40 European countries, Australia and New Zealand), Sanofi (Africa, the Middle East, Turkey, and the Commonwealth of Independent States including Russia) and Auxilium. Auxilium possesses the rights to Stendra in the U.S. and Canada.

VIVUS licensed the product from Mitsubishi Tanabe Pharma Corp. Auxilium launched the drug in the U.S. in Dec 2013, while Menarini launched the drug in the EU in Apr 2014.

Our Take

We are pleased with the inclusion of 15 minutes onset of action in Stendra’s label. We believe it will give an edge to Stendra over currently approved PDE5 inhibitors including Viagra, Levitra and Cialis (none of which have an onset of action as fast as Stendra) and help boost market share.

VIVUS, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy). Some better-ranked biopharma stocks worth considering, include Amgen Inc. (AMGN - Free Report) and Gilead Sciences Inc. (GILD - Free Report) . Both are Zacks Rank #1 (Strong Buy) stocks.




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