SOURCE: Theravance, Inc.

April 02, 2007 16:05 ET

Theravance Announces Positive Results of Clinical Program in Beyond Advair Collaboration

GSK/Theravance Collaboration Advances Program

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- April 2, 2007 -- Theravance, Inc. (NASDAQ: THRX) today announced the results of two studies in an ongoing Phase 2b clinical program to assess the efficacy and safety of the investigational bronchodilators GSK642444 ('444) and GSK159797 ('797), the lead long-acting Beta2 agonist (LABA) compounds in the Beyond Advair collaboration with GlaxoSmithKline (GSK). In the studies, '444, a GSK-discovered compound, and '797, a Theravance-discovered compound, each given once daily, achieved clinically significant increases in bronchodilation at least equivalent to salmeterol given twice daily. Both compounds exhibited a pharmacodynamic profile similar to other inhaled LABAs, with little impact on heart rate.

All doses studied of compound '444 (25, 100 and 400 mcg), dosed once a day, showed greater bronchodilator activity than salmeterol dosed twice a day, and produced placebo-adjusted, dose-dependent mean changes from baseline FEV1 (forced expiry volume in one second) of over 200 mL at trough on the fourteenth day of treatment. The two lower doses also produced smaller changes than salmeterol in placebo-adjusted weighted mean heart rate over the first four hours after dosing on day fourteen.

All doses studied of compound '797 (10, 15 and 20 mcg), dosed once a day, showed comparable bronchodilator activity to salmeterol, dosed twice a day, at trough on the fourteenth day of treatment. The lowest dose also produced a placebo-adjusted, weighted, mean heart rate change over the first four hours after dosing on day fourteen that was similar to that for salmeterol.

"The collaboration is very excited by these results, which showed that both compounds, dosed once daily, demonstrated bronchodilation similar to or better than salmeterol dosed twice daily, and are pleased that both '444 and '797 will continue in development," said Rick E Winningham, CEO of Theravance. "We are especially encouraged by the enhanced bronchodilator effect and potentially greater therapeutic index of '444, which will progress as the lead compound into 28-day studies in combination with inhaled corticosteroids. We will also continue to explore an optimized dose range for '797 as a backup."

The goal of the Beyond Advair collaboration between Theravance and GSK is to develop a once-a-day inhaled combination medicine comprised of a LABA and a corticosteroid for the treatment of asthma and chronic obstructive pulmonary disease.

Study Design

The studies were randomized, crossover, double-blind, placebo- and active-controlled, to examine the efficacy and safety of three inhaled doses each of '444 (25, 100 and 400 mcg) and '797 (10, 15, and 20 mcg) over 14 days in approximately 55 patients with asthma who were controlled on inhaled corticosteroids. The goal in each study was to show improvement in FEV1 over baseline corticosteroid therapy with once-daily '444 or '797 that was similar to or better than salmeterol, given twice daily.

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 April 3, 2007. To participate in the live call by telephone, please dial 800-987-6057 from the U.S., or 785-832-1523 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 May 3, 2007. An audio replay will be available through 11:59 p.m. Eastern Daylight Time on April 17, 2007 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 2104642.

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, two are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc. 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, 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 the conference call 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 Theravance's 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 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

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    Theravance, Inc.
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    Director, Investor Relations
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