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VIVUS Announces Positive Results From TA-1790 Erectile Dysfunction Clinical Study.

Business Editors & Health/Medical Writers

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Nov. 7, 2002

VIVUS, Inc. (Nasdaq NM: VVUS) today announced positive results of a clinical study designed to evaluate the safety and efficacy of TA-1790, its proprietary phosphodiesterase type 5 (PDE5) inhibitor, in men with erectile dysfunction (ED). This in-clinic trial, which utilized a RigiScan(R) device to measure penile rigidity in association with visual sexual stimulation, demonstrated that the peak efficacy response to TA-1790 was comparable to or greater than that observed with Viagra(R). Importantly, the peak penile response with TA-1790 occurred at the earliest time point evaluated in this study, 20-40 minutes after drug administration, as compared to the peak response to Viagra, which occurred 60-120 minutes after administration. Additionally, TA-1790 was well tolerated, with no indication of hypotension or visual disturbances.

"This double-blind, placebo-controlled in-clinic study demonstrated that TA-1790 is capable of restoring penile function in men with erectile dysfunction. The effects of TA-1790 were observed earlier than with Viagra, and the peak responses to TA-1790 were comparable to or better than those seen after treatment with a 50mg dose of Viagra," commented Dr. John Dietrich, VIVUS' Vice President of Research and Development. "This rapid onset of action was expected based on animal studies in which the maximum effect of TA-1790 was observed 15 minutes after administration," added Dr. Dietrich.

In addition to its rapid onset of action, in-vitro studies have demonstrated high specificity for the PDE5 enzyme. The following table presents the ratio of the amount of drug required to inhibit 50% of the activity of four important phosphodiesterase enzymes (PDE1, PDE3, PDE6 and PDE11) relative to each drug's inhibitory activity against PDE5. For example, it takes 8140 times as much TA-1790 to inhibit PDE1 as it does PDE5.

 Fold Selectivity vs. PDE5

TA-1790(a) 8140 22581 1 158 17900
Tadalafil(b) 4450 14800 1 187 5
Sildenafil(b) 80 4630 1 11 780
Vardenafil(b) 500 7140 1 25 1160

(a) Tanabe unpublished data
(b) Gbekor Journal of Urology Vol. 167.Abstract #967.2002

TA-1790's high specificity for PDE5 may predict a superior clinical safety profile. For example, preclinical studies have shown TA-1790 to have a substantially less blood pressure lowering effect than sildenafil in animals treated concomitantly with nitrates.

"TA-1790 has demonstrated a rapid onset of action, high specificity for PDE5 and a short plasma half life. We believe these characteristics are ideal for an on-demand treatment for ED," commented Dr. Dietrich.

VIVUS, Inc. is a pharmaceutical company engaged in the development of innovative therapies for the treatment of quality-of-life disorders in men and women, with a focus on sexual dysfunction. Current development programs target Female Sexual Dysfunction (FSD), Erectile Dysfunction (ED) and Premature Ejaculation (PE). The Company developed and markets in the U.S. MUSE(R) (alprostadil) and ACTIS(R), two innovations in the treatment of erectile dysfunction, and has partnered with Meda AB (Stockholm:MEDAa.ST) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS has partnered exclusively with Paladin Labs (TSE: PLB) to market and distribute MUSE.

NOTE TO INVESTORS: VIVUS will hold a conference call to discuss results from TA-1790 erectile dysfunction clinical study today, November 7, 2002, beginning at 1:00 p.m. Eastern Time. You are invited to listen to this call (live or 14 days) via the Internet at the VIVUS website,

Note to editors and investors: Additional written materials, recent releases and Company information are available through a variety of sources, including the VIVUS website and the VIVUS Fax-On-Demand Service 1-888-329-5719).

This news release contains forward-looking statements about the potential commercialization of products in treating male sexual dysfunction and reflects management's current beliefs. However, as with any pharmaceutical under development, there are significant risks in development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this news release will be successful or that any product will receive regulatory approval for any indication. Further, even if the Company were to receive regulatory approval for a product, there could be no assurance that such a product would prove to be commercially successful. Please see the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's Form 10-K and Forms 10-Q, which identify these and other risks and uncertainties that may cause actual results or events to differ materially from those described in this news release.
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Publication:Business Wire
Geographic Code:1USA
Date:Nov 7, 2002
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