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Amylin Pharmaceuticals, Inc.

Organization Profile

Amylin Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of drug candidates for the treatment of diabetes, obesity and cardiovascular disease.

The company has two late-stage, first-in-class diabetes product candidates currently under review by the FDA, exenatide (exendin-4) and SYMLIN (pramlintide acetate). AMLN has a global collaboration with Eli Lilly for the development and commercialization of exenatide and an extended release formulation, exenatide LAR. Building on its experience in the diabetes field, AMLN also is developing candidates for obesity and cardiovascular disease by utilizing its research experience with the metabolic properties common to all three conditions.

Technology and Clinical Strategy

Exenatide (exendin-4) is being developed to treat Type II diabetes and is the first in a new class of compounds known as incretin mimetics. Amylin reported positive results from three pivotal studies of exenatide in late 2003, for which it received a $35 million milestone payment from Lilly. AMLN submitted a New Drug Application to the FDA for exenatide in June 2004, which was accepted for review by the FDA in September 2004. The Prescription Drug User Fee Act (PDUFA) goal date is April 30, 2005.

SYMLIN is intended for the treatment of people with diabetes who use insulin. In October 2001, the company received an approvable letter from the FDA for SYMLIN as an adjunctive therapy with insulin to treat Type I and insulin-using Type II diabetes, subject to satisfactory results from additional clinical trials. In December 2001, after consultation with the FDA, AMLN conducted a seven-month dose titration study focused on safety involving about 300 patients with Type I diabetes, and four small pharmacology trials to enhance suggested prescribing information. The results of these studies were submitted in an amendment to the SYMLIN New Drug Application. In December 2003, AMLN received a second approvable letter, requesting additional data. In September 2004, Amylin submitted a complete response to the FDA’s second approvable letter for SYMLIN. The Prescription Drug User Fee Act (PDUFA) goal date is March 20, 2005.

Exenatide LAR, a long-acting release formulation of exenatide is in Phase 2 development. This program utilizes Alkermes’ Medisorb injectable sustained release drug delivery technology. The goal of the exenatide LAR program is to develop a sustained-release, subcutaneous injection of exenatide. In November 2004, the company announced the decision to initiate a Phase 2 multi-dose study of exenatide LAR (long-acting release) in patients with type 2 diabetes using a once-a-week dosing regimen. The multi-dose study is expected to begin in the first quarter 2005. Data from the ongoing Phase 2 single-dose study have demonstrated sustained release of exenatide with no dose-limiting side effects. The injection has been well tolerated.

Building on its experience in the diabetes field, AMLN is developing candidates for cardiovascular disease and obesity by utilizing its research experience with the metatbolic properties common to all three conditions. The company has four additional drug candidates in its pipeline: AC137 (pramlintide), a Phase 2 program, is being studied for the treatment of obesity. AC2592 (GLP-1 continuous infusion), currently in Phase II trials, is being studied as a treatment for congestive heart failure. AC162352 (PYY 3-36) is a Phase I candidate being evaluated for its potential in the treatment of obesity. AC3056 is in Phase I trials as a potential treatment for cardiovascular disease.

Disease Focus

Cardiovascular Disorder (misc) , Diabetes , Diabetes -- Type 1 (insulin dependent) , Diabetes -- Type 2 (non-insulin dependent) , Diabetic cardiovascular disease , Obesity