The hits just keep coming for San Diego’s Amylin Pharmaceuticals (NASDAQ: [[ticker:AMLN]]), and not in a good way.
Amylin and Japanese strategic partner Takeda Pharmaceutical said today they have suspended a clinical trial examining the safety and effectiveness of an obesity drug candidate that combines pramlintide acetate, a synthetic analog of the natural hormone Amylin, with metreleptin, an analog of human leptin.
The companies formed a collaboration in November 2009 to co-develop the combination of pramlintide and metreleptin for obesity, in a deal with potential value to Amylin of more than $1 billion The partners say the study was voluntarily halted to investigate a new antibody-related laboratory finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity.
Amylin notes that its decision does not affect another drug development program that is investigating the use of metreleptin to treat rare forms of lipodystrophy.
Earlier this month, Amylin, Lilly, and Alkermes suffered a setback in their development of exenatide once-weekly (Bydureon) for Type 2 diabetes, when they disclosed the treatment did not provide superior efficacy over an existing treatment.
The biggest shock came last October, when the FDA refused to approve exenatide once-weekly (Bydureon) for U.S. sale to diabetes patients. Regulators insisted that the company provide more data on the drug’s effect on heart rhythms.
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.
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