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VIVUS, Inc. (Nasdaq: VVUS) announced that phase 3 data on avanafil, a next generation oral phosphodiesterase type 5 (PDE5) inhibitor therapy being investigated for the treatment of erectile dysfunction (ED), will be presented next Tuesday at the American Urological Association (AUA) 2010 Annual Meeting in San Francisco, California. Irwin Goldstein, M.D., clinical professor of surgery at the University of California, San Diego, and director of sexual medicine at Alvarado Hospital in San Diego, will deliver an oral presentation as part of the Late-Breaking Science Forum session on Tuesday, June 1 entitled: "Avanafil for the Treatment of Erectile Dysfunction: Results of a Phase 3, Multi-Center, Randomized, Double Blind, Placebo-Controlled Clinical Trial."
Dr Goldstein's presentation will include the results from the REVIVE (TA-301) study a randomized, double-blind, placebo-controlled phase 3 study of avanafil in 646 men with a history of generalized ED.
"The AUA annual meeting is an excellent clinical forum for presenting the initial phase 3 experience regarding the use of avanafil in men with erectile dysfunction. We are pleased to have Dr. Goldstein leading the first scientific presentation of these pivotal study results," stated Wesley Day, Ph.D., vice president, clinical development at VIVUS. "The market for oral ED therapies continues to grow with worldwide sales of approved oral PDE5 inhibitors expected to exceed $4 billion this year. With successful intercourse in 15 minutes, avanafil may be favorably positioned in this market. We believe that, if approved, avanafil will represent an advance in the treatment of ED, and we are pleased to have the opportunity to review these data with the urology community at this important clinical gathering."
Following are details about the upcoming presentation:
American Urological Association 2010 Annual Meeting, Moscone Center, San Francisco, California
Date and Time: Tuesday, June 1, 2010, 1:40 PM
Session: Late-Breaking Science Forum, 1:00-3:40 PM
Presentation Title: Avanafil for the Treatment of Erectile Dysfunction: Results of a Phase 3, Multi-Center, Randomized, Double Blind, Placebo-Controlled Clinical Trial
Location: Moscone South 103
Presenter: Irwin Goldstein, M.D.
About VIVUS
VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. The company's lead product in clinical development, QnexaŽ, has completed phase 3 clinical trials for the treatment of obesity and an NDA has been filed and accepted by the FDA, with an action date of October 28, 2010. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor for the treatment of erectile dysfunction. MUSEŽ (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2009 and periodic reports filed with the Securities and Exchange Commission.
