[Updated 8/4/11, 6:55 pm. See below.] San Diego’s Amylin Pharmaceuticals (NASDAQ: AMLN) and Japan’s Takeda Pharmaceutical threw in the towel today, saying they are discontinuing development of pramlintide/metreleptin for the treatment of obesity.
[Updated 8/4/11, 6:55 pm to clarify explanation] Observers feared something like this might happen in March, when Takeda and Amylin suspended a clinical trial examining the safety and effectiveness of the compound, which combines pramlintide, an analog of the natural hormone Amylin, with metreleptin, an analog of human leptin. The program was in mid-stage development as a formulation for twice-a-day injection. The partners halted the study voluntarily to investigate antibody-related findings with metreleptin in two patients who had been participating in a broader obesity trial.
A spokeswoman for Amylin, however, tells me in an email this evening, “the joint decision to discontinue the pramlintide/metreleptin program was not related to the March announcement, but rather to the reasons specified in this afternoon’s press release.”
In their statement, the companies said their joint decision was based on a commercial reassessment of their prospects as well as “evolving dynamics” within the field of obesity therapeutics. Amylin and Takeda plan to evaluate other assets for treating obesity under the terms of their existing collaboration agreement. The two companies signed that agreement in late 2009, a partnership deal that was once valued at more than $1 billion for Amylin.
Amylin CEO Dan Bradbury told Luke in January the company was still working on getting the right formulation of metreleptin and pramlintide before moving to a late-stage clinical trial.
[Updated 8/4/11, 6:55 pm to correct nature of single heart study required by FDA] Amylin said earlier this week it had re-submitted its application to the FDA for another drug—exenatide once-weekly (Bydureon)—with two partners, Indianapolis-based Eli Lilly (NYSE: LLY), and Waltham, MA-based Alkermes (NASDAQ: ALKS). In an unexpected move last October, the FDA refused to approve exenatide once-weekly for sale to U.S. diabetes patients until the partners conducted a study focused on an irregular heart rhythm known as QT prolongation.
In their statement today, Amylin and Takeda said the abandoned study was not expected to require either company to revise its latest financial guidance for their respective 2011 fiscal years.
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