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Theravance, Inc. CEO Discusses Q2 2012 Earnings Results - Earnings Call Transcript

Now turning to the second respiratory program LAMA/LABA or UMEC/VI. UMEC/VI is a once a day investigational medicine combining a long acting Muscarinic Antagonist, Umeclidinium Bromide or UMEC and a LABA, VI, for the maintenance treatment of patients with COPD. UMEC/VI is also administered by the new Ellipta inhaler. Earlier this month GSK and Theravance announced positive result from four pivotal Phase 3a studies of UMEC/VI involving over 4,000 patients with COPD.

These four studies include two 24 week efficacy studies that compared the combination UMEC/VI, its components and placebo and two 24 week active comparator studies that compared the combination with tiotropium. Tiotropium, as you know, is a widely prescribed maintenance bronchodilator for COPD.

The data from these four studies form part of the overall evaluation of efficacy and safety of the UMEC/VI combination and the individual components in approximately 6,000 COPD patients. The ongoing registration program includes a 52 week safety study and two replicate 12 week crossover exercise studies. Subject to the successful completion of these additional studies, GSK plans to commence global regulatory submission for UMEC/VI from the end of 2012 which is ahead of schedule.

Turning now to our third respiratory program the MABA program, ‘081 the lead asset is a single molecule bifunctional bronchodilator with both a muscarinic antagonist and a beta2 receptor agonist activity. The result from the Phase 2b study and a number of non-clinical enabling studies will inform the selection of the most appropriate dose and dosing interval for ‘081 and progression to Phase 3 will be dependent upon successful completion of these ongoing enabling studies.

In September, several presentations covering data from these respiratory programs will be given at the European Respiratory Society Annual Congress in Vienna. Importantly, data form a majority of the studies of the Phase 3a FF/VI programs for both COPD and asthma will be presented including the exacerbation studies. Also a late breaker presentation will describe data from the Phase 2b low dose crossover study of UMEC and COPD. Data from the Phase 2b study for MABA will also be presented at ERS.

Read the rest of this transcript for free on seekingalpha.com

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