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GlaxoSmithKline, Theravance Complete Phase III Programme Of LAMA/LABA

GlaxoSmithKline plc and Theravance Inc. (THRX) announced the completion of the phase III programme of an investigational LAMA/LABA involving approximately 6,000 patients with chronic obstructive pulmonary disease.

LAMA/LABA is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide, or UMEC, a long-acting muscarinic antagonist, or LAMA, and vilanterol, or VI, a long-acting beta2 agonist, or LABA, administered using the ELLIPTA inhaler. The LAMA/LABA Studies investigate the 52-week parallel group safety study evaluated the long-term safety and tolerability of UMEC 125mcg alone and the combination UMEC/VI 125/25mcg compared to placebo in approximately 500 patients.

On 2 July 2012, GSK and Theravance announced the completion of four pivotal studies for UMEC/VI. The pivotal programme for UMEC/VI also includes a 52-week safety study, which is now complete. Two non-pivotal 12-week crossover exercise studies will also be included in the registrational package as they are now also complete. The companies said these recently completed studies support GSK's plans to commence global regulatory submissions for UMEC/VI from the end of 2012.

The companies said full results of these studies will be presented at future scientific meetings.

by RTT Staff Writer

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