Amylin: pipeline offers robust, sustainable opportunities beyond commercialized drugs

By Jennifer Lanning Drey

Portland, Ore., Oct. 24 - Amylin Pharmaceuticals, Inc. has a robust pipeline of potential products that extends beyond Byetta and Symlin for diabetes and covers several therapeutic areas, president and chief operating officer Daniel Bradbury told investors during the company's research and development day on Tuesday.

"What we're building here is a sustainable company with sustainable opportunity for growth in the future," Bradbury said.

The company is making preparations to begin a phase 3 clinical study of pramlintide as a treatment for obesity but said the trial's start date and design will be guided by ongoing pramlintide combination studies.

"We believe that pramlintide for obesity is the foundation of our neurohormonal integrated therapy for obesity. This is the first brick in this wall that we're building," senior vice president of research Dr. Alain Baron said.

In the fourth quarter, Amylin started four new clinical obesity studies, including a study of pramlintide with currently available oral agents for obesity. The company is also studying pramlintide in combination with Leptin and pramlintide in combination with PYY3-36, Baron said.

In 2007, the company will study pramlintide in combination with PYY3-36 and Leptin to treat obesity.

"There's a lot of data for us to be able to construct the best plan forward for the best product to address this great unmet medical need," Baron said.

Baron also told investors that the company's neurohormonal integration program for treatment of diabetes is advancing and will gear its efforts toward normalizing glucose in patients with type 2 diabetes.

The company is also studying AC2592 in phase 2 clinical trials for congestive heart failure.

Byetta, Symlin opportunities

Amylin also continues to support its commercialized products, Symlin and Byetta, through label expansions and additional studies, Dr. Orville Kolterman, senior vice president of clinical and regulatory affairs at Amylin, said on Tuesday.

The company has submitted a supplemental New Drug Application supporting room temperature storage of the Byetta pen and hopes to have a product available by early 2007, he said.

In addition, the company is enrolling patients in a study to generate additional data requested by the Food and Drug Administration in an approvable letter for Byetta as monotherapy.

The company expects data from the study to be available by the end of 2007. Once submitted, the data would undergo a six-month review process by the FDA.

Amylin is a biopharmaceutical company based in San Diego, Calif.

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