Men with erectile dysfunction can get relief twice as quickly as was possible in the past. VIVUS, Inc. (NASDAQ: VVUS) received FDA approval for STENDRA (avanafil) tablets. The firm says that it is the “first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.” ED apparently affects an estimated 52 percent of men between the ages of 40 and 70. Tobacco and alcohol use and cardiovascular conditions and prostate cancer can make the problem more likely.

So, the market is a huge one.

VIVUS shares are near a 52-week high and trade at $25.50. Shares have risen four-fold from their 52-week low. VIVUS’s market cap is only $2.3 billion. There is reason, however, for caution on Wall St. VIVUS has no revenue, and its expenses were $47 million last year, and have been $165 million over the last three years.

Many of the commercial benefits for VIVUS remain in the future. The company reported:

VIVUS is currently in discussion with potential partners to commercialize STENDRA in the United States and in its territories in the rest of the world.

STENDRA (avanafil) is licensed from Mitsubishi Tanabe Pharma Corporation. VIVUS has development and commercial rights to STENDRA for the treatment of sexual dysfunction worldwide with the exception of certain Asian Pacific Rim countries. In South Korea, STENDRA is approved and is marketed by JW Pharma under the brand name Zepeed.

The drug has side-effects similar to other ED drugs–pain, nausea, and the chance that an erection can last more than 4 hours.

Douglas A. McIntyre

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