GlaxoSmithKline And Theravance Announce Expansion Of The Horizon Programme With Start Of Large Phase 2B Study Of LABA In COPD Patients

Main Category: COPD
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 29 Feb 2008 - 0:00 PDT

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GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) announced the expansion of the Horizon programme into development of a next-generation combination treatment for patients with chronic obstructive pulmonary disorder (COPD). A large Phase 2b COPD dose-optimisation study with the lead long-acting beta agonist (LABA) GW642444 ('444) has commenced, with screening of the first patient undertaken.

This is in addition to the four large Phase 2b asthma dose-optimisation studies; one with '444 and three with the lead inhaled corticosteroid (ICS) GW685698 ('698), which commenced in December 2007, as part of the ongoing Horizon programme.

Darrell Baker, SVP GSK Respiratory Medicines Development Centre said, "Delivering a once-daily treatment for asthma and COPD, where there remains a considerable unmet need, is a priority. We believe that this is an important milestone within the Horizon programme and we eagerly await results from the ongoing asthma and now COPD studies that will help guide future development of these important assets."

"We are very pleased to have initiated the larger Phase 2b study with the lead compound '444 in COPD," said Rick E Winningham, Chief Executive Officer at Theravance. "With '444 now in large Phase 2b studies in both asthma and COPD, we have met two important targets that bring us closer to our joint goal of bringing a new treatment option to patients in these important therapeutic areas."

Study design

This double-blind, placebo controlled trial will enrol approximately 600 patients with moderate to severe COPD from study centres across the USA, Europe and international locations. Each patient will be randomised to receive a once-daily dose of placebo or '444 via a novel inhaler throughout the 28-day treatment period. The primary endpoint of the study will be efficacy, evaluated by change from baseline FEV1 (pre-bronchodilator and pre-dose) at the end of the 28-day treatment period, with a number of secondary endpoints also evaluated.

These study data, taken together with the data obtained from parallel studies currently being undertaken with '698, will be used to guide future development plans in COPD and progression into large-scale Phase 3 COPD combination studies. No Phase 2b COPD monotherapy studies with '698 will be undertaken as part of the Horizon programme.

About GSK

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit http://www.gsk.com.

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 six programs in development, four are in late stage - its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc., the Horizon program with GlaxoSmithKline plc, the Gastrointestinal Motility Dysfunction program, and TD-1792, an investigational antibiotic for the treatment of serious Gram-positive bacterial infections. By leveraging its proprietary insight of multivalency toward drug discovery focused primarily on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit the company's web site at http://www.theravance.com.

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

GlaxoSmithKline forward-looking atatements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Business and Prospects in the company's Annual Report on Form 20-F for 2006.

Theravance forward-looking statements

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, 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 prospectus filed with the Securities and Exchange Commission (SEC) pursuant to Rule 424(b)(5) of the Securities Act of 1933 on January 17, 2008 and the risks discussed in our periodic 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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