SOURCE: Theravance, Inc.

October 31, 2007 16:05 ET

Theravance Announces Initiation of Phase 2 Clinical Program with its MABA Compound in COPD

SOUTH SAN FRANCISCO, CA--(Marketwire - October 31, 2007) - Theravance, Inc. (NASDAQ: THRX) announced today that GSK has initiated a Phase 2 clinical study of GSK961081, an investigational bifunctional muscarinic antagonist-beta2 agonist compound for the treatment of chronic obstructive pulmonary disease (COPD). The compound was discovered by Theravance and is being developed by GlaxoSmithKline plc (GSK) under the parties' Strategic Alliance Agreement.

GSK961081 ('081) is a potent, long-acting, inhaled bronchodilator featuring a bifunctional mechanism of action, combining both muscarinic antagonist and beta2 agonist pharmacology in a single molecule. The goal of this program is to develop a once-a-day medicine with improved efficacy relative to existing therapies of inhaled beta2-adrenoceptor agonists and anti-muscarinic drugs used for the treatment of COPD.

GSK initiated the Phase 2 study based upon favorable data from pre-clinical and Phase 1 studies completed earlier this year. In Phase 1 randomized double-blind, placebo-controlled, single- and multiple-dose studies that enrolled healthy volunteers, '081 was generally well tolerated and demonstrated evidence of bronchodilation over 24 hours after a single dose and after seven consecutive daily doses.

The Phase 2 double-blind, randomized, study is designed to evaluate the safety and efficacy of '081 doses administered once daily for 14 days in a dry powder inhaler. Approximately 40 patients will be randomized to receive '081 dosed once daily, salmeterol dosed twice daily plus tiotropium dosed once daily, or placebo in this crossover design study.

"Currently some patients with COPD are using a combination of both an inhaled muscarinic antagonist and an inhaled beta2 agonist," said Michael Kitt, MD, Senior Vice President of Development at Theravance. "By combining the activities of the two approaches to COPD treatment, along with high lung selectivity, in one MABA compound, we aim to develop a medicine with greater efficacy than single mechanism bronchodilators, such as tiotropium or salmeterol, and with equal or better tolerability. We look forward to further exploring in Phase 2 the potential of this compound to provide a better treatment option for the many patients who suffer from obstructive pulmonary disease."

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

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 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:
    Allison Parker
    Director, Investor Relations
    Email Contact