SOURCE: Theravance

June 27, 2005 09:00 ET

Theravance Announces Results of Phase 2 Clinical Study Showing 24-Hour Bronchodilation With Investigational Medicine

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- June 27, 2005 -- Theravance, Inc. (NASDAQ: THRX) announced the results of a Phase 2 clinical study designed to assess the bronchodilator duration, safety and tolerability of the investigational, inhaled bronchodilator, GSK159797, the lead compound in the Beyond Advair collaboration with GlaxoSmithKline (GSK). The results showed clinically significant increases in bronchodilation over 24 hours with little impact on heart rate at clinically relevant doses.

GSK159797 ('797) is an inhaled, longer-acting Beta2 agonist (LABA) discovered by Theravance through the application of multivalent drug design in a drug discovery program dedicated to finding new medicines for respiratory disease such as asthma and COPD.

The study was a single dose, placebo-controlled crossover design to test the bronchodilatory effect, safety and tolerability of multiple dose levels of '797 administered by a dry powder inhaler in 20 patients with mild asthma. Doses in the anticipated clinical range produced clinically significant increases in FEV1 through 24 hours, with little change in heart rate. At 24 hours, 10 and 20 mcg doses of '797 produced adjusted mean changes from baseline FEV1 of 460 mL and 540 mL, respectively, compared to a change of 130 mL for placebo. The placebo-corrected mean maximum heart rate increase over the 26-hour period of measurement was 1.0 beats per minute (b.p.m.) for the 10 mcg dose and 2.7 b.p.m. for the 20 mcg dose.

"The goal for the Beyond Advair program is to develop an effective once-a-day inhaled medicine that combines the anti-inflammatory properties of an inhaled corticosteroid with the bronchodilation of a LABA to improve patient compliance and outcomes," said Michael Kitt, MD, Senior Vice President of Development at Theravance. "Based on the encouraging results from this and prior studies, we intend to initiate Phase 2b studies later this year in a larger patient population."

About Theravance

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Of the six programs in development, two are in late stage -- telavancin and the Beyond Advair collaboration with GlaxoSmithKline. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, overactive bladder and gastrointestinal motility disorders. 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

NOTE: 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. Examples of such statements include statements relating to the goals and expected results of clinical and preclinical studies, statements regarding the potential benefits and mechanisms of action of drug candidates and the enabling capabilities of Theravance's approach to drug discovery and its proprietary insights. 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 naturally 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. These and other risks are described in greater detail under the heading "Factors Affecting Results, Including Risks and Uncertainties" contained in Item 2, "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 13, 2005 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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