Theravance Announces Positive Results From Phase 2 Clinical Study in Chronic Constipation With Investigational Compound TD-5108
All Three Doses Studied Achieved Primary Endpoint
SOUTH SAN FRANCISCO, CA - Theravance, Inc. today announced positive results from its 400-patient ACCORD Phase 2 clinical study in chronic constipation with TD-5108, an investigational compound for the treatment of chronic constipation and other disorders related to reduced gastrointestinal (GI) motility. In the study, all three doses of TD-5108 achieved statistical significance in the primary endpoint and key secondary endpoints. At the two lowest doses, TD-5108 was well tolerated with a low incidence of adverse events.
All three doses of TD-5108 (15 mg, 30 mg, and 50 mg), given once daily, achieved the primary endpoint of an increased number of spontaneous bowel movements (SBM) per week over baseline compared with placebo. The average weekly increases over the four-week period in SBM from baseline for patients treated with TD-5108 were 3.6 for the 15 mg treatment group (p 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 be a better and safer medicine for the treatment of patients with severe constipation and possibly constipation predominant irritable bowel syndrome. The goal of the GI Motility Dysfunction program is to develop an efficacious and well tolerated product with once-a-day oral dosing and few food restrictions.
GSK Option
Pursuant to the Company's 2004 Strategic Alliance with GlaxoSmithKline plc (GSK), GSK has an option to license TD-5108 for further development and commercialization under pre-agreed terms. For additional information regarding this agreement, please refer to SEC filings on the investor relations portion of Theravance's website at www.theravance.com.
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.
Conference Call and Webcast Information
The Company has scheduled a conference call to discuss this announcement beginning at 8:00 a.m. Eastern Daylight Time on June 26, 2007. To participate in the live call by telephone, please dial 800-289-0572 from the U.S., or 913-981-5543 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the company's web site at www.theravance.com. To listen to the live call, please go to the web site 15 minutes prior to its start to register, download, and install any necessary audio software.
A replay of the conference call will be available on the Company's web site for 30 days through July 26, 2007. An audio replay will be available through 11:59 p.m. Eastern Daylight Time on July 10, 2007 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 6215644 .
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, three are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc., its GI Motility Dysfunction program, 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 www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.
This press release contains and the conference call will contain 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 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 conference call 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, 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 May 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.