Amylin growing obesity program, plans human trials of novel compound this year

By Jennifer Lanning Drey

Eugene, Ore., June 1 - Amylin Pharmaceuticals, Inc. is growing its late-stage obesity program and plans this year to start human tests of a new compound discovered to be an obesity agent, said Ginger Graham, president and chief executive officer of Amylin, in a presentation at the Friedman Billings Ramsey 2006 Growth Investor Conference.

"We are continuing our interest in obesity as a new therapeutic category at Amylin and have growing pipeline activity in this important area," said Graham.

She did not identify the drug that the company is working on.

The company's focus on obesity as a new therapeutic category stemmed from Amylin's previous diabetes research, which led to the product launches of Symlin (pramlintide acetate) and Byetta (exenatide) last year.

"Throughout the life of our research on Symlin, we have observed weight loss in our controlled studies, even for individuals who are on insulin," said Graham.

Amylin completed a phase 2 clinical trial of pramlintide in obese, but not diabetic, patients last year. The study found average weight loss from baseline for pramlintide groups to be 8.4 to 13.4 pounds. The 400 patients also showed progressive weight loss through the 16 weeks of the study, Graham said during the presentation.

Beyond Amylin's pipeline of potential obesity products, the company is performing ongoing development work in diabetes therapy. Amylin is in the process of enrolling approximately 300 patients for an open label non-inferiority study that will compare a long-acting-release (LAR) dose of exenatide to the current form of Byetta. Data are expected in 2007.

"We believe this study could form a basis of submission for the New Drug Application for LAR with regard to the clinical and efficacy data," said Graham.

Symlin and Byetta, Amylin's two first-in-class diabetes products also continue to bring revenue to the company, she said. Symlin sales demonstrated 17% growth in the first quarter, while Byetta experienced 37% growth.

In addition, Byetta is on track to file a Supplemental New Drug Application for disposable pen delivery in mid-2006.

Amylin is a biopharmaceutical company based in San Diego.

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