GlaxoSmithKline and Theravance announce expansion of the Horizon programme with start of large Phase 2B study of LABA in COPD patients

GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today 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 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 www.theravance.com. THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.