SOURCE: Theravance, Inc.

June 13, 2005 08:34 ET

Theravance Announces Initiation of Phase 1 Clinical Study With Investigational Medicine for Respiratory Disease

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- June 13, 2005 -- Theravance, Inc. (NASDAQ: THRX) announced today that GlaxoSmithKline (GSK) has enrolled the first subjects in a Phase 1 clinical study designed to assess the safety, tolerability and pharmacokinetics of Theravance's investigational, inhaled bronchodilator, GSK656398 (formerly known as TD-5742), for the treatment of chronic obstructive pulmonary disease (COPD).

GSK656398 is an inhaled, long-acting muscarinic antagonist (LAMA) 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 COPD and asthma. The LAMA program is one of three respiratory programs under joint development by GSK and Theravance.

Inhaled muscarinic antagonists are among the most frequently used bronchodilators for COPD and work by inhibiting muscarinic receptors on lung airways, which lead to bronchodilation and improved lung function. Theravance's intent with the research program was to discover inhaled LAMAs that produce prolonged blockade of airway muscarinic receptors as a result of being highly lung-retained. Higher lung retention should also lead to lower concentrations of drug in the systemic circulation, an approach that could result in improved tolerability over the market leader at doses with comparable efficacy.

"The goal for our program is to develop an effective once-a-day inhaled medicine that is better tolerated than the market leading medicines," said Michael Kitt, MD, Senior Vice President of Development at Theravance. "In addition, at higher doses, a more lung-selective LAMA might offer improved efficacy with comparable or improved tolerability."

Dr. Patrick P. A. Humphrey, Executive Vice President of Research at Theravance, said, "We believe that our multivalent approach to drug discovery has the potential to provide a superior next-generation inhaled medicine to treat COPD. GSK656398 is the sixth potential medicine discovered at Theravance to enter into human clinical testing in the last four years. In 2001, telavancin, an investigational antibiotic for the treatment of serious Gram-positive infections, entered into human clinical studies and is currently in Phase 3. In 2002, the lead compound in our Beyond Advair collaboration with GSK entered the clinic, followed by our second compound in that program in 2004. We also initiated Phase 1 studies in our overactive bladder program in 2003 and in our gastrointestinal prokinetic program in early 2005."

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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    Theravance, Inc.
    David Brinkley
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