SOURCE: Theravance, Inc.

October 17, 2007 06:00 ET

Theravance Reports Additional Data on Investigational Compound TD-5108 at 2007 American College of Gastroenterology Annual Scientific Meeting

Phase 2 Study Shows That TD-5108 Increased Bowel Movement Frequency and Proportion of Patients with Adequate Relief from Chronic Constipation

SOUTH SAN FRANCISCO, CA--(Marketwire - October 17, 2007) - Theravance, Inc. (NASDAQ: THRX) announced today that Phase 2 results with the investigational compound TD-5108 will be presented today at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Philadelphia, Pennsylvania. The ACG Meeting is focused on clinical updates on gastrointestinal disorders and new or potential new therapies. The TD-5108 results were accepted as a late-breaking presentation.

TD-5108 was discovered by Theravance through the application of its multivalent drug design in a research program dedicated to finding new treatments for GI motility disorders. TD-5108 is a potent, highly selective agonist with high intrinsic activity at the 5-HT4 receptor. Relative to other 5-HT receptor types, TD-5108 is > 500-fold selective for binding to the human 5-HT4 receptor. Theravance anticipates that the high degree of selectivity of TD-5108 provides the potential for it to become a next-generation medicine for the treatment of patients with severe constipation and possibly constipation predominant irritable bowel syndrome.

The Phase 2 study was a double-blind, randomized, placebo-controlled, parallel-group, multicenter study in which 401 patients with chronic constipation were treated for four weeks with one of three doses of TD-5108 (15, 30 or 50 mg) or placebo. During an initial two-week baseline period, patients averaged 1.2 spontaneous bowel movements (SBM) per week with an average of 0.2 SBMs per week associated with a sensation of complete evacuation (defined as a complete spontaneous bowel movement or CSBM). Among the results observed with TD-5108 were:

--  Clinical activity for all doses studied as assessed by multiple
    endpoints.
--  A statistically significant increase from baseline in average weekly
    SBM frequency over the 4 week treatment period (the primary endpoint for
    the study).  For example, the average change from baseline in SBM per week
    was 3.6 for patients treated with TD-5108 15 mg compared with 1.4 for
    placebo.
--  A statistically significant increase from baseline in average weekly
    CSBM frequency over the 4 week treatment period.  The average change from
    baseline in CSBM per week was 2.3 for patients treated with TD-5108 15 mg
    compared with 0.6 for placebo.
--  A statistically significant increase in the percentage of patients
    with greater than or equal to 3 SBM per week (78% during week 4 at 15 mg
    versus 41% with placebo) and the percentage of patients with greater than
    or equal to 3 CSBM per week (48% during week 4 at 15 mg versus 9% with
    placebo).
--  Statistically significantly greater percentage of patients reporting
    adequate relief of their constipation (62% during week 4 at 15 mg versus
    26% with placebo).
--  Significantly greater activity compared to placebo was also seen for
    other secondary endpoints including improvement in straining and bloating
    and the frequency of rescue laxative use.
--  TD-5108 was generally well tolerated with low incidence of adverse
    events.  Overall, the most common adverse events included headache,
    diarrhea, nausea and vomiting.
    

"The data presented at ACG today provide additional information on the positive Phase 2 results previously reported from our approximately 400-patient study with TD-5108," said Michael Kitt, Senior Vice President of Development at Theravance. "The results show in more detail that TD-5108 increases GI motility, providing clinically and statistically significant relief from chronic constipation, and that, at the lowest active dose of 15 mg, is generally well tolerated."

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, four are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc., the Gastrointestinal Motility Dysfunction program, the Beyond Advair collaboration with GlaxoSmithKline plc and TD-1792 for the treatment of serious Gram-positive infections. By leveraging its proprietary insight of multivalency toward drug discovery focused on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in large markets. For more information, please visit the company's web site at www.theravance.com.

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 preclinical and clinical studies and regulatory review, statements regarding the potential benefits and mechanisms of action of drug 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 preclinical and clinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe, ineffective, inferior or not superior, 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 Item 1A of Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 8, 2007 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.

Contact Information

  • Contact Information:

    Theravance, Inc.
    Investors/Media
    Allison Parker
    Director, Investor Relations
    650-808-4100
    Email Contact