Before we get started we’d like to remind you that this conference call contains forward-looking statements regarding future events and the future performance of Theravance. Forward-looking statements include anticipated results and other statements regarding Theravance’s goals, expectations, strategy and beliefs. These statements are based upon the information available to the company today and Theravance assumes no obligation to update these statements as circumstances change.Future events and actual results could differ materially from those projected in the company’s forward-looking statements. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the company’s Form 10Q filed with the Securities & Exchange Commission. I will now turn the call over to Rick Winningham, our Chief Executive Officer. Rick E. Winningham
These past few weeks have been very exciting for Theravance with important developments in our respiratory programs partnered with GSK and our peripheral Mu Opioid receptor antagonist TD-1211 opioid induced constipation or (OIC). Let me begin with our respiratory programs which are partnered with GSK starting with FF/VI, with the proposed brand name Relvar in the European Union and Breo in the United States. FF/VI is an investigational once a day inhaled combination medicine comprised of fluticsone furoate an inhaled corticosteroid and vilanterol a long acting Beta2 agonist or LABA for the maintenance treatment of chronic obstructive pulmonary disease or COPD and asthma. GSK and Theravance recently reached a major milestone with the submission of regulatory applications for FF/VI. For the treatment of COPD, GSK filed for the 125 dose of FF/VI in the US and the EU. For the treatment of asthma GSK filed for both the 100/25 microgram and the 200/25 microgram doses of FF/VI in the EU. For asthma in the US, GSK and Theravance are reviewing the strategy for a future filing. For both indications FF/VI would be administered by a new dry powder inhaler with the proposed brand name Ellipta.
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