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» Amylin Pharmaceuticals, Inc. Q2 2010 Earnings Call Transcript
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» Amylin Pharmaceuticals, Inc. Q4 2009 Earnings Call Transcript
I will now turn the call over to Dan Bradbury.Dan Bradbury Thanks, Michael, and welcome to our fourth quarter and year-end call for 2010. This afternoon, our comments will build on the press release issued earlier today. In a few moments, Mark will provide additional details on the quarter's underlying financial results and comment on our outlook for 2011. Vince will then review our commercial activity during the fourth quarter of 2010 and highlight our plans for 2011. As those of you who followed us throughout 2010 were aware, we have placed great emphasis at Amylin on two highly interrelated goals: First, driving revenue while operating with financial discipline; and second, advancing our pipeline of first-in-class products, most notably BYDUREON. Since receiving our second complete response letter for BYDUREON in October, we have continued progress towards achieving our highest corporate priority, submitting our response to the FDA in 2011. I will now take a minute to provide you with an update regarding our efforts to address the key requests in the October complete response letter. As we have previously discussed, the complete response letter requested a thorough QT study, also known as the tQT study, with exposures of exenatide higher than typical therapeutic levels of BYDUREON. In addition to the request for a tQT study, the letter requested the submission of the results of the DURATION-5 study to evaluate the efficacy and the labeling of the safety and effectiveness of the commercial formulation of BYDUREON. With DURATION-5 having been completed in December of 2009, we are currently prepared to submit the results without substantive additional efforts. Regarding the request for tQT study, we submitted the protocol to the FDA and have recently received written feedback indicating their approval of the study design. Details of the exenatide infusion study, which we expect to begin early next month in healthy volunteers, are contained in the presentation we posted on our website just prior to this call. Importantly, with additional clarity on the design of the tQT study, we now expect to submit our response to the agency in the second half of this year.
As we work to complete the tQT study, we are also advancing several important lifecycle initiatives for BYDUREON and exenatide molecule. We are continuing to add centers and enrolled patients for our ongoing EXCEL cardiovascular outcomes study, which is investigating the potential for BYDUREON to reduce cardiovascular events relative to the standard of care in patients with Type 2 diabetes.In the first half of this year, we expect to report data from DURATION-6, a head-to-head comparative efficacy study investigating weekly dose BYDUREON relative to the most recent entrant to the GLP-1 class, liraglutide, which is injected every day. Additionally, in the first half of 2011, we expect data from a Phase II dose finding study of a monthly dose suspension formulation of exenatide. Recall that this formulation uses the same microsphere technology as BYDUREON, but is dosed just once a month and does not require reconstitution. Also on track is the development of a pen device for BYDUREON, which we expect to launch by the end of 2012 or in early 2013. We are also moving forward with our other late stage programs in lipodystrophy and in obesity. Last quarter, we submitted the clinical and non-clinical sections of a Biologics License Application or BLA for the use of metreleptin to treat diabetes and/or hypotriglyceridemia in pediatric and adult patients with inherited or acquired lipodystrophy. Our plan is to submit the chemistry, manufacturing and controls section and complete the BLA by the end of 2011. With fast-track and priority review designation, metreleptin could be available to patients by mid-2012. Since there are no treatments currently approved for this indication, we believe that metreleptin could become an important new option to help patients impacted by this rare and debilitating metabolic disorder. Pramlintide/metreleptin, our investigational weight management therapy that leverages Amylin and leptin agonism, continues to advance towards Phase III clinical studies. Our current focus with partner Takeda remains on co-formulating pramlintide and metreleptin, scaling up our manufacturing processes, and finalizing our Phase III clinical plans. Read the rest of this transcript for free on seekingalpha.com