AMLN Amylin Pharmaceuticals, Inc. (MM)

Amylin Pharmaceuticals Provides Update On Clinical Development Programs SAN DIEGO, Dec. 5 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) today presented an update on its clinical development programs at a reception webcast from San Diego, CA. Included in the presentation were new data from its pramlintide (AC137) obesity program and details of a Phase 2 study recently initiated in its AC2592 development program for congestive heart failure. The successful completion of the AC137 study and initiation of the AC2592 study mark the achievement of all of the Company's stated development milestones for 2004. Amylin discussed results from its recently completed study in obese subjects evaluating the safety and tolerability of the drug candidate pramlintide (AC137). In the study, obese subjects were able to tolerate higher doses of pramlintide than those previously studied, and achieved clinically and statistically significant weight loss. Approximately 90% of subjects receiving pramlintide were able to progress to the highest dose of 240 micrograms three times a day. Consistent with previous observations, the most common side effect observed with pramlintide compared to placebo was mild, transient nausea. This blinded, placebo-controlled study included 204 obese subjects, 160 without diabetes and 44 with non-insulin-treated type 2 diabetes. After a 1-week placebo lead-in period, study participants received pramlintide or placebo three times a day before meals and were asked to maintain their usual diet and exercise routines. During a 4-week dose-escalation period, subjects increased study medication to their highest tolerated dose, or a maximum of 240 micrograms three times a day. Following this dose-escalation period, subjects continued with their maintenance dose for 12 weeks. Pramlintide- treated subjects completing the 16-week active treatment period experienced progressive weight loss with an approximate 3.6% (3.5 kg) average reduction in body weight compared to placebo (p