Amylin & Takeda Halt Obesity Drug Development

[Updated 8/4/11, 6:55 pm. See below.] San Diego’s Amylin Pharmaceuticals (NASDAQ: [[ticker: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: [[ticker:LLY]]), and Waltham, MA-based Alkermes (NASDAQ: [[ticker: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.

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.