GSK and Theravance announce progression of LAMA/LABA combination treatment into Phase III development for COPD

Relovair™ programme expanded by start of large Phase IIIb COPD outcomes study


London UK and South San Francisco, CA--

GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced major milestones in two clinical development programmes focused on new treatments for patients with chronic obstructive pulmonary disease (COPD), a leading cause of chronic illness and death worldwide.

The first is the initiation of the Phase III programme for the once-daily LAMA/LABA dual bronchodilator GSK573719/vilanterol (‘719/VI), which will evaluate over 5,000 patients globally. Patients are now being enrolled in a large safety study, which will be followed shortly by four large pivotal studies that will compare improvements in lung function between ‘719/VI, its components, placebo and tiotropium. The programme will also include two further studies assessing the effect of ‘719/VI on exercise endurance.

The second is the start of an extensive study of 16,000 patients to assess the potential for Relovair to improve survival in those with COPD and a history of, or at risk from, cardiovascular disease. Relovair is a once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) combination treatment, currently under development, comprising fluticasone furoate and vilanterol (FF/VI).

About the ‘719/VI Phase III Programme
‘719/VI combines two bronchodilator molecules currently under development - ‘719, a long-acting muscarinic antagonist (LAMA) and VI, a long-acting beta agonist (LABA). These molecules act through two mechanisms: antagonism of acetylcholine muscarinic receptors and agonism of beta2 adrenoreceptors.The medicine will be administered using a new dry powder inhalation device.

The study initiated today is a 52-week randomised study to evaluate the long term safety and tolerability of ‘719 (125mcg) alone, as well as the combination with ‘719/VI (125/25mcg). The Phase III programme will investigate two doses of ‘719 (125mcg and 62.5mcg) and ‘719/VI (125/25mcg and 62.5/25mcg) across the six further studies, which will all commence within the next quarter.

About the Relovair Outcomes Study
FF/VI commenced Phase III development for COPD in October 2009 and the programme now includes approximately 6,000 patients across five pivotal registration studies.

The additional study is an extensive outcomes trial across 1,100 global sites and will run alongside the existing COPD programme.

The primary objective is to prospectively evaluate the effect of the combination (FF/VI, 100/25mcg) compared with placebo on survival in COPD patients with moderate disease and a history of, or at risk from, cardiovascular disease. Secondary objectives will evaluate the effect of FF/VI compared with placebo on the rate of decline in lung function, as well as on cardiovascular endpoints including cardiovascular death, heart attacks and strokes.

This study will evaluate the clinical outcomes of patients receiving standard cardiovascular care (including cardiovascular medications) versus patients receiving FF/VI in addition to receiving standard cardiovascular care (including cardiovascular medications).

Darrell Baker, Senior Vice President for the GSK Respiratory Medicines Development Centre, commented, “This Relovair study demonstrates our commitment to evaluating survival outcomes for patients with COPD throughout the world. Cardiovascular risk factors remain a very important cause of morbidity and mortality in this disease and this study is crucial to assessing whether Relovair can benefit these patients”.

This is a four arm, multicentre, randomised, double-blind, parallel-group study, with treatment administered once daily via a novel dry powder inhaler. The total duration of the study will be determined by the number of events in the study, with each patient being treated for between 15 and 44 months based on current estimates.

The results are not expected prior to the anticipated regulatory submission and will not form part of the initial New Drug Application (NDA)/Marketing Authorisation Application (MAA).

Relovair is also in Phase III clinical development for the treatment of asthma.

Relovair™ is a trademark of the GlaxoSmithKline group of companies.

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

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. The company’s key programmes include: the RELOVAIR™ programme and Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) programme, both with GlaxoSmithKline plc, and VIBATIV™ (telavancin) with Astellas Pharma Inc. By leveraging its proprietary insight of multivalency toward drug discovery, Theravance is pursuing a best-in-class 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.

VIBATIV is a trademark of Astellas Pharma Inc.