LONDON and SOUTH SAN FRANCISCO, CA--(Marketwired - Jul 12, 2013) - GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the licence application for the use of fluticasone furoate (FF) and vilanterol (VI) (proposed brand name RELVAR™ ELLIPTA™) in patients with chronic obstructive pulmonary disease (COPD) has been withdrawn from the current Japanese New Drug Application (JNDA). The review of FF/VI for use in patients with asthma is continuing to progress through the normal Japanese regulatory process as part of this JNDA.

The submission for the once-daily investigational medicine FF/VI contained data from six studies in over 6,000 COPD patients. Japanese patient specific efficacy data were generated from two 6-month efficacy (lung function) studies. These studies demonstrated the benefit of the combination FF/VI compared with placebo on the co-primary endpoints of 0-4 hour weighted mean FEV₁ and trough FEV₁. However, in an assessment of the contribution of each of the individual components, while VI achieved a statistically significant improvement in weighted mean FEV₁ the contribution of FF on improvement of lung function did not achieve statistical significance in these studies.

As no Japanese patients were enrolled in either of the 52-week exacerbation studies also conducted with FF/VI, GSK believes that the data from the 6-month studies alone may be insufficient to support the efficacy of the combination and its components in this specific patient group. As a result, a decision has been taken to withdraw COPD from the current JNDA at this time. The application for FF/VI as a potential treatment for asthma remains under review in Japan.

GSK and Theravance are currently determining next steps and possible clinical studies of FF/VI for the treatment of Japanese patients with COPD to support the resubmission. Further details will be provided in due course.

RELVAR™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of the brand name RELVAR™ is not approved by any regulatory authority.

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 and strategic collaborations with pharmaceutical companies. 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 central nervous system (CNS)/pain. Theravance's key programmes include: RELVAR™ ELLIPTA™ or BREO™ ELLIPTA™ (FF/VI), ANORO™ ELLIPTA™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta₂ Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist programme. By leveraging its proprietary insight of multivalency to 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 Theravance's web site at www.theravance.com.