Profile: Amylin Pharmaceuticals, Inc. (AMLN.O)

Amylin Pharmaceuticals, Inc., incorporated in September 1987, is a biopharmaceutical company engaged in the discovery, development and commercialization of drug candidates for the treatment of diabetes, obesity and other diseases. As of December 31, 2008, the Company was marketing two medicines to treat diabetes: BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection. In addition to its marketed products, the Company is working with Eli Lilly and Company (Lilly) and Alkermes, Inc. (Alkermes) to develop exenatide once weekly. The Company maintains a discovery research program focused on peptide and protein therapeutics.

BYETTA (exenatide) injection

BYETTA is an approved medicine in a new class of compounds called incretin mimetics. The Company began selling BYETTA in the United States in June 2005, as an add-on therapy for glycemic control in patients with type 2 diabetes who have not achieved adequate gylcemic control and who are taking metformin and/or sulfonylurea, two oral therapies for type 2 diabetes. In December 2006, the United States Food and Drug Administration (FDA) approved BYETTA as an add-on therapy for glycemic control in people with type 2 diabetes who have not achieved adequate glycemic control by using a thiazolidinediene (TZD).

BYETTA provides glucose control by augmenting the body’s natural physiologic processes, allowing the body to respond to blood glucose changes as they occur. BYETTA directly affects the beta cells responses to elevated glucose by enhancing insulin secretion; this effect dissipates as glucose levels approach the normal range. BYETTA also restores first-phase insulin response. BYETTA is administered twice a day by using a fixed dose injection, and requires no dose adjustments due to changes in meal size or composition, exercise or other variables. No additional glucose monitoring is required with BYETTA therapy.

SYMLIN (pramlintide acetate) injection

SYMLIN belongs to a class of compounds called amylinomimetics. The Company began selling SYMLIN in the United States in April 2005, as adjunctive therapy to mealtime insulin to treat diabetes. SYMLIN is an FDA-approved medication addressing glucose control for patients with type 1 diabetes. SYMLIN is indicated for use in people treated with insulin alone or, in the case of patients with type 2 diabetes, treated with insulin with or without one or more oral medications. SYMLIN works with insulin to smooth out the peaks in blood glucose levels to give patients more stable blood glucose levels after meals and throughout the day. In January 2008, the Company announced the availability of the SymlinPen 120 and the SymlinPen 60 pen-injector devices for administering SYMLIN.

Product Pipeline Programs

Amylin Pharmaceuticals, Inc. has late-stage and early-stage development programs in the therapeutic areas of diabetes and obesity. Exenatide once weekly is the Company’s late-stage development program in diabetes. Exenatide is the active ingredient in BYETTA and is combined with technology developed by the Company and its partner, Alkermes, to provide a sustained release delivery of exenatide.

In October 2007, the Company announced positive results of a 30-week pivotal comparator study comparing treatment with exenatide once weekly to treatment with BYETTA. The study enrolled 295 patients not achieving adequate glucose control with either diet and exercise or with use of oral glucose-lowering agents. In June 2008, it announced results from a 52-week open-label clinical study that showed the durable efficacy of exenatide once weekly. In this extension of its 30-week DURATION-1 study, patients either remained on exenatide once weekly or switched from BYETTA to exenatide once weekly for an additional 22 weeks.

In June 2006, the Company entered into an agreement with Nastech Pharmaceutical Company (Nastech) to develop a nasal spray formulation of exenatide. In 2008, the Company reported the results of a nasal exenatide Phase I clinical trial, which showed that intranasal administration of exenatide was well tolerated and resulted in enhanced glucose-dependent insulin secretion and improved postprandial glucose control.

In February 2006, the Company reported results from a 16-week Phase II dose-ranging study with pramlintide in obese subjects. The Company has conducted clinical studies using pramlintide in combination with leptin and with PYY 3-36. PYY 3-36 is the third compound the Company is studying in connection with its INTO program. It is developing Y-family mimetics as drug candidates, but have been utilizing the native form of PYY 3-36 for the investigation of potential treatments of obesity. In November 2007, the Company announced data from a 14-day safety and tolerability Phase I clinical trial showing that PYY 3-36 when used in combination with pramlintide was well tolerated.

In November 2007, the Company announced results from a 24-week proof-of-concept study with pramlintide and metreleptin combination treatment in overweight or obese subjects. At the end of the study, the combination treatment reduced body weight on average 12.7 %, significantly more than treatment with pramlintide alone (8.4%). Subjects treated with pramlintide and metreleptin lost an average of 25 pounds from the beginning of the study compared with an average of 17 pounds for subjects treated with pramlintide alone. Subjects receiving pramlintide and metreleptin continued to lose weight through the end of the study compared to those treated with pramlintide alone, whose weight loss had stabilized towards the end of the study.

The Company competes with AstraZeneca, Bristol-Myers Squibb Company, GlaxoSmithKline, Eli Lilly and Company, Merck & Co., Novartis AG, Novo Nordisk, Pfizer, Sanofi-Aventis and Takeda Pharmaceuticals.