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VIVUS and TANABE Sign Licensing Agreement for PDE5 Inhibitor Compound for the Treatment of Male and Female Sexual Dysfunction.

Health/Medical Writers

MOUNTAIN VIEW, Calif.--(BW HealthWire)--March 5, 2001

VIVUS Inc. (Nasdaq NM:VVUS), a pharmaceutical company developing innovative products to improve quality of life, and TANABE SEIYAKU, a leading Japanese pharmaceutical company, today announced that VIVUS has licensed TANABE's proprietary phosphodiesterase type 5 (PDE5) inhibitor compound TA-1790 for the oral and local treatment of male and female sexual dysfunction.

TA-1790 is a fast-acting, highly selective, potent PDE5 inhibitor. PDE5 inhibitors, such as Pfizer's (NYSE:PFE) Viagra(R), have been shown to be effective oral treatments for male erectile dysfunction (ED) and are being studied as potential therapies for female sexual dysfunction (FSD).

"We are honored to be chosen by TANABE to develop this very important new compound. This license agreement demonstrates VIVUS' commitment to be the leader in developing treatments for sexual dysfunction in both men and women," said Leland F. Wilson, president and CEO of VIVUS. Mr. Shoei Nakashima, managing director of Research and Development at TANABE, commented: "VIVUS was selected because of their clinical and regulatory expertise in developing products for treating sexual dysfunction. In addition, VIVUS holds important patents that allow them to develop and commercialize products such as TA-1790 for local delivery in both male and female sexual dysfunction."

"Licensing TA-1790 is a very significant milestone for VIVUS," said Peter Tam, director of Corporate Development at VIVUS. "We believe TA-1790 has important characteristics that will provide advantages and allow us to compete successfully in the first-line oral ED market. This compound also provides us with the opportunity to develop other products, such as a new generation of potentially more effective locally delivered combination products with alprostadil (PGE1) for both male and female sexual dysfunction."

"Tanabe has successfully completed a Phase I clinical trial with an oral formulation of TA-1790 and has extensively evaluated this compound in well-accepted in vivo and in vitro preclinical models," commented Dr. John Dietrich, VIVUS' vice president of Research and Development. This work has shown TA-1790 to be a potent and specific inhibitor of the PDE5 enzyme, which is found in penile tissue. VIVUS plans to begin clinical trials of the oral formulation of TA-1790 for ED in the second half of this year.

Inhibition of the PDE5 enzyme by compounds such as TA-1790 has been shown to increase blood flow to the penis, resulting in improved erections in men suffering from erectile dysfunction. Preclinical studies have shown that TA-1790 is equally as effective as sildenafil, the active ingredient in Viagra(R), in inducing penile rigidity in several different animal species, including primates. In vitro studies have demonstrated that TA-1790 inhibits PDE5 more selectively than does sildenafil. In these studies, sildenafil demonstrated greater inhibition of other PDE enzymes, which may result in unwanted side effects in tissues and organs. TA-1790 has also been shown in in vitro models to cause less inhibition at adenosine receptors; adenosine may play a role in maintaining normal cardiac rhythm.

Viagra is contraindicated in patients taking organic nitrates such as nitroglycerin because of the potential for an interaction between the two drugs that can result in a marked reduction in blood pressure. Preclinical studies have demonstrated that co-administration of TA-1790 with organic nitrates causes less of a decrease in blood pressure as compared to the concomitant administration of sildenafil and nitrates. If confirmed in clinical trials, TA-1790 could decrease the risk of significant reduction in blood pressure for patients taking nitrates.

Absorption and metabolism studies in animals suggest that TA-1790 may have nearly ideal characteristics for an on-demand treatment for erectile dysfunction. If the rapid onset of action that has been demonstrated in animals, on the order of 10-15 minutes, is confirmed in humans, TA-1790 may be well suited for use shortly before commencing sexual activity. In addition, the half-life to TA-1790 in human volunteers is less than two hours. From a safety standpoint, the shorter half-life reduces the amount of time the body is exposed to the drug and may therefore decrease potential side effects.

Under the terms of the agreement, VIVUS has acquired worldwide rights, except Japan, China and certain Pacific Rim countries, to develop and commercialize TA-1790. Tanabe will be responsible for manufacturing TA-1790. In exchange, Tanabe has received an undisclosed up-front payment and will receive additional payments based on certain development, regulatory and sales milestones. In addition, Tanabe will receive royalties on net sales of products containing TA-1790.

VIVUS is a pharmaceutical company developing innovative products to improve quality of life disorders in men and women, with a focus on sexual dysfunction. The company developed and markets in the U.S. MUSE (alprostadil) and ACTIS(R) (recently cleared for OTC marketing), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE:ABT) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS is partnered exclusively with Paladin Labs to market and distribute MUSE. VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA, during the fourth quarter of 2000.

TANABE SEIYAKU CO., LTD. is a leading Japanese pharmaceutical company that specializes in developing and marketing pharmaceutical products such as diltiazem (Herbesser(R)) and imidapril (Tanatril(R)) to treat cardiovascular diseases. Currently, diltiazem is sold in more than 120 countries and imidapril is sold in Asia and European countries. The company is dedicated to the discovery, research and development of pharmaceutical products that meet emerging medical needs. For more information, visit the Web site at www.tanabe.co.jp.

Note to editors and investors: Additional written materials, recent releases and company information are available through a variety of sources, including the VIVUS home page (www.vivus.com) and the VIVUS Fax-On-Demand Service (1-888-329-5719).

This news release contains forward-looking statements about the potential commercialization of the compound, TA-1790 in treating male and female sexual dysfunction that reflects management's current beliefs. However, as with any pharmaceutical under development, there are significant risks in development, regulatory approval and commercialization of new compounds. There are no guarantees that future clinical studies will confirm the preliminary results discussed in this news release or that the compound TA-1790 will receive regulatory approval for any indication. Further, even if the company were to receive regulatory approval for a product, there can 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 Form 10-Qs, 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:Mar 5, 2001
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