Amylin says approval of Symlin/basel product would double drug's target audience

By Jennifer Lanning Drey

Eugene, Ore., Sept. 11 - Amylin Pharmaceuticals, Inc. believes an approved product combining Symlin (pramlintide acetate) and basal insulin glargine would approximately double the target audience for the compound, said Mark Foletta, chief financial officer of Amylin, at the Bear Stearns health care conference on Monday.

The San Diego biopharmaceutical company plans to submit a supplemental New Drug Application for the Symlin/basel combination before the end of the year, Foletta told investors.

Last week, the company announced that a 16-week study evaluating the safety and efficacy of the combination had demonstrated improved diabetes control in patients with type 2 diabetes.

Symlin has generated $29.3 million in sales from its April 2005 launch through the end of the second quarter, Foletta said.

Foletta also said Monday that Amylin will begin two clinical trials in its obesity program before the end of the year. The first will study pramlintide in combination with leptin, which the company found led to 12% body weight loss when tested in obese rats.

In addition, Amylin plans to begin clinical trials before the end of 2006 for a second-generation amylinomimetic, optimized for weight loss in obese animals.

"We are building the company for the long-term here, certainly focused on our commercial products but also on our pipeline," Foletta said.

The company also expects a response from the Food and Drug Administration around the end of the year regarding its application to use Byetta (exenatide) injection in combination with thiazolidinedione.

Amylin believes an approval of the combination could add 1.5 million patients to the available population for Byetta, Foletta said.

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