SOURCE: Theravance, Inc.

October 09, 2006 08:30 ET

Theravance Initiates Phase 2 Clinical Program in Gastrointestinal Motility Dysfunction

First Patient Dosed in Chronic Constipation Study

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- October 9, 2006 -- Theravance, Inc. (NASDAQ: THRX) announced today that the first patient was dosed in a Phase 2 clinical study of TD-5108, an investigational compound for the treatment of chronic constipation and other disorders related to reduced gastrointestinal (GI) motility. The goal of this program is to develop a product with once-a-day oral dosing and improved efficacy relative to current therapy.

TD-5108 is a selective 5-HT4 (5-hydroxytryptamine4) receptor agonist that has shown prokinetic activity in preclinical and clinical studies. Theravance initiated the Phase 2 program based on preclinical data and results from Phase 1 studies completed earlier this year which showed pharmacokinetics consistent with once-daily dosing. In these randomized,double-blind, placebo-controlled, single- and multiple-ascending dose Phase 1 studies which enrolled 77 healthy volunteers, TD-5108 demonstrated a dose-dependent prokinetic effect, with rapid onset at the higher doses, and a tolerability profile consistent with compounds in this class. The prokinetic effect of TD-5108 was observed, within the dose range studied, throughout the 14-day multiple-dose study.

The Phase 2 multi-center, randomized, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of a range of TD-5108 doses administered once daily for 28 days. The Phase 2 study will be conducted in the United States with a goal of enrolling approximately 350 patients.

"As a result of our promising preclinical and clinical studies, we're moving forward into Phase 2 to better understand the potential use of TD-5108 in treating the many patients who suffer from GI motility disorders," said Michael Kitt, MD, Senior Vice President of Development at Theravance.

About Gastrointestinal Motility Dysfunction and Chronic Constipation

Gastrointestinal motility dysfunction, a major contributing factor to many disorders of the GI tract, refers to the abnormal rate and coordination of food moving out of the stomach and through the rest of the digestive tract. Reduced GI motility can cause symptoms of bloating, nausea, pain and constipation and can adversely affect quality of life. Disorders of reduced motility include chronic constipation, constipation predominant irritable bowel syndrome, functional dyspepsia, and delayed gastric emptying. The prevalence of chronic constipation is estimated to be about 5% of the adult population in the United States.

About Theravance

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. Of the five programs in development, two are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc. and the Beyond Advair collaboration with GlaxoSmithKline. By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the company's web site at

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the goals, timing and expected results of clinical and preclinical studies, statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the goals and timing of seeking regulatory approval of our product candidates, the enabling capabilities of Theravance's approach to drug discovery and its proprietary insights, statements concerning expectations for product candidates through development and commercialization and projections of revenue and other financial items. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to delays or difficulties in commencing or completing clinical and preclinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe, ineffective, inferior or not superior, and delays or failure to achieve regulatory approvals, and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading "Risk Factors" contained in Theravance's 10-Q filed with the Securities and Exchange Commission (SEC) on August 4, 2006, and the risks discussed in our other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.

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