Vivus Files NDA for the Treatment of Erectile Dysfunction

Business Wire, March 28, 1996

MENLO PARK, Calif.--(BUSINESS WIRE)--March 28, 1996--VIVUS, Inc. (NASDAQ: VVUS) today announced that the company has submitted a New Drug Application (NDA) to the FDA for the use of MUSE (alprostadil) in treating erectile dysfunction, commonly known as impotence.

Leland F. Wilson, president and chief executive officer of VIVUS, said, "We are pleased to have achieved this key milestone and to have accomplished our goal of filing in early 1996. Just a few years ago impotence was not approached as a treatable disorder. Now erectile dysfunction is viewed as a physical problem, caused by vascular disease, diabetes, prostate surgery, trauma or other organic causes, which affects millions of men and their relationships with their partners."

MUSE (alprostadil) is a departure from existing therapies for erectile dysfunction, based on the discovery that the urethra can absorb certain medications and transport them into the surrounding erectile tissues. The product is a small, single-use, disposable applicator containing medication. The stem of the applicator is inserted approximately one inch into the urethra where the medication is released.

The agent used in VIVUS' first product is alprostadil, a synthetic version of prostaglandin E1, a naturally occurring vasodilator approved by the FDA for treating erectile dysfunction via needle injection in 1995 and prescribed for other uses since 1981.

VIVUS' phase III studies used to support the filing were double-blind, placebo-controlled trials conducted at 58 medical centers in the United States. The blinded phase of the studies involved 996 men and their partners who used the product or placebo at home for three months.

In November 1995, summary results of the phase III study program were presented at the Western Section meeting of the American Urological Association. Intercourse was reported by 65 percent of participants who received MUSE (alprostadil) compared to 19 percent on placebo (p less than 0.001).

No increased risk of serious adverse events was found and the most common side effect, transient penile pain, was noted in 11 percent of active doses. Of the patients entered in the trial, 88 percent completed the study with only one percent dropping out due to pain.

Additional data, including information on partners and quality-of-life parameters, were submitted as part of the filing. These findings will be presented the American Urological Association Meeting in May and at other scientific meetings during 1996.

Approximately 30 percent of men between the ages of 40 and 70 in the United States suffer from moderate to complete erectile dysfunction, a condition that increases with age. The potential world market is estimated at 47 million men by the year 2000.

Founded in 1991, VIVUS is a leader in the development of advanced therapeutic systems for the treatment of erectile dysfunction, commonly referred to as impotence. The company has pioneered a unique therapy for erectile dysfunction, known as the transurethral system for erection. This therapy consists of a proprietary, non-invasive, drug-delivery system that delivers pharmacologic agents via the urethra.

CONTACT: Vivus, Inc.

Barbara Clark, 415/325-5511

David Yntema, 415/325-5511