Theravance Inc (THRX)
J.P. Morgan Global Healthcare Conference Transcript
January 9, 2013 1:30 PM ET
Rick Winningham - Chairman and CEO
Jessica Fye - J.P. Morgan
Jessica Fye - J.P. Morgan
Previous Statements by THRX
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Thanks, Jessica, and thanks to J.P. Morgan for inviting us to present here again this year. As we look -- as we close 2012 and look into 2013 just has a potential this year to be a terrifically exciting year for the company. And I hope to describe and to share some of that potential excitement with you today.
During the course of the presentation, I'm likely to make a few forward-looking statement, there's our safe harbor please refer to our existing SEC documents for risk factors and everything else I'm not going to give time to read the - speed read the Safe Harbor statement.
So significant progress in 2013 or 2012 just taking a moment to look back with the RELVAR/BREO program under the GSK Theravance banner regulatory applications were submitted in the U.S. and the EU and the Japan and I'll explain more on what the expectations are in 2013 for the RELVAR/BREO program but clearly last year being a critical year for us and for GSK getting the Phase 3 programs complete and getting the applications in.
The second program the ANORO or UMEC/VI announced positive Phase 3 results in COPD, and really through a heroic amount of work by the GSK organization as well as complemented by the team of Theravance. We're able to get the NDA submitted before the end of the year in 2012 and as you might have read at a press release that we issued this morning, we're able to submit it in to the EU this morning so as a terrific amount of work by GSK and complemented by the Theravance team.
And finally with the GSK Theravance programs, the MABA Phase 2b data was presented at European Respiratory Society Meeting and the collaboration made the decision to advance a MABA is a monotherapy into a Phase 3 trials which will take place of this year the initiation. And to begin work on 081 the MABA compound combining it with fluticasone furoate to develop a once a day two product triple and take those that combination in the Phase 3 enabling studies through the course of 2013.
So with GSK Theravance a banner year really in 2012 setting up 2013. For the Theravance programs along again 2012 extraordinarily productive positive Phase 2b results for opioid-induced constipation program TD-1211.
VIBATIV very excited with the favorable outcome of the advisory committee nosocomial pneumonia in November, 4208 Long-Acting Muscarinic Antagonist that we are developing in a nebulizer for the treatment of COPD, a specific niche there that we think there's great opportunity and a complementary opportunity there is programs we're working on GSK, in COPD but it's a very complementary to all the dry powder work that we're doing with GSK.
That we've got that Phase 2b study off the ground TD-9855, we initiated a phase 2 study in Fibromyalgia meaning we now have with the 9855 a Phase 2 study underway with ADHD as well as Fibromyalgia, I'll spend a little bit more time on that program later in the presentation.
And importantly, entered into a series of important partnerships, Merck in cardiovascular disease, Alfa Wassermann and G.I. motility disorders and R-Pharm for the commercialization and development of VIBATIV, in Russia and Commonwealth of Independent states as well as the development of 1792, very important heterodimer antibiotic.
So this capital 2012 capitalizes, the capitalized really on what Theravance has been doing over the last decade, focusing on medicines that make a difference. Our discovery platform has yielded 20 over 20 development candidates. We've got filings and I talked about now, VIBATIV is approved in the United States, Europe and Canada.
And we have used partnering to propel simultaneous with the development of pipeline are high-value programs namely those programs with GSK, we've received significant funding over time from corporate partners and we have focused on building value in the company from discovery through commercialization, and now we're on the eve of commercialization with the respiratory programs and with the reintroduction of VIBATIV.
Looking at 2013 as I said 2012 was important, 2013 will be more significant for the company, with RELVAR/BREO, we have an advisory committee coming up in COPD on March 7. The PDUFA date for BREO the name of the product in the United States in COPD's in May 2013, and we have a potential EMA action on RELVAR and keep in mind with the BREO we filed for COPD in the United States, RELVAR we filed both asthma and COPD in Europe.
ANORO the program formally called UMEC/VI. We've submitted the global regulatory filings -- will submit global regulatory filings by GSK, outside the United States we begin with the European filing noted in the press release this morning. And we have the opportunity for FDA action on ANORO before the end of the year given that we were able to get to the NDA for ANORO in December.