FDA Approves BYETTA(R) (exenatide) Injection for Expanded Combination Use

Millions of People Using Thiazolidinediones Now Have New Treatment Option

to Manage Type 2 Diabetes

Dec 22, 2006, 00:00 ET from Amylin Pharmaceuticals, Inc. from ,Eli Lilly and Company

    SAN DIEGO and INDIANAPOLIS, Dec. 22 /PRNewswire-FirstCall/ -- Amylin
 Pharmaceuticals, Inc. (Nasdaq:   AMLN) and Eli Lilly and Company (NYSE:   LLY)
 announced today that the U.S. Food and Drug Administration (FDA) has
 approved BYETTA(R) (exenatide) injection as an add-on therapy to improve
 blood sugar control in people with type 2 diabetes who have not achieved
 adequate control on a thiazolidinedione (TZD). Healthcare professionals
 will be educated on this additional use for BYETTA in the coming weeks.
     In a clinical trial designed to evaluate BYETTA for use in combination
 with a TZD, 62 percent of patients who added BYETTA to their existing
 medicines achieved an A1C (a measure of blood glucose levels over time) of
 7 percent or less, compared to 16 percent of the patients on placebo.
 People taking BYETTA also lost an average of 3.3 pounds over 16 weeks,
 compared to an average weight reduction of 0.4 pounds in the other group.
 The most common adverse event associated with BYETTA was nausea (40
     "Due to the progressive nature of type 2 diabetes, previous approaches
 to management frequently failed to achieve target levels of A1C, or
 resulted in subsequent failure over one to three years," said Dr. Robert
 Ratner, Vice President for Scientific Affairs at the MedStar Research
 Institute in Washington, DC. "The combination of exenatide with metformin,
 sulfonylureas, or TZDs not only expands our options to achieve optimal
 glycemic control, but does so with accompanying weight loss."
     BYETTA improves blood sugar control by lowering both post-meal and
 fasting (early morning) glucose levels resulting in better long-term
 control as measured by A1C. BYETTA controls blood sugar through several
 physiologic actions, including the stimulation of insulin secretion only
 when blood sugar is high. BYETTA restores the first-phase insulin response
 (an activity of the cells in the pancreas that is lost in patients who have
 type 2 diabetes), decreases glucose output from the liver, regulates
 gastric emptying, and decreases food intake. The majority of patients in
 long-term BYETTA clinical studies also experienced weight loss.
     "Almost half a million people with type 2 diabetes have used BYETTA to
 help reduce their blood sugar," said Ginger L. Graham, Chief Executive
 Officer, Amylin Pharmaceuticals. "Now, even more people -- those who use
 another common category of oral medicines, TZDs -- have a new treatment
 option and have the opportunity to benefit from the unique clinical
 benefits of BYETTA."
     "There are two core defects to type 2 diabetes, beta cell failure and
 insulin resistance," said Vince Mihalik, Global Brand Development Leader
 for Diabetes and Endocrine, Lilly. "The ability of BYETTA to improve beta
 cell responsiveness and lower weight complements the TZD effect on insulin
 resistance very nicely."
     About BYETTA
     BYETTA is the first in a new class of drugs for the treatment of type 2
 diabetes called incretin mimetics. BYETTA exhibits many of the same effects
 as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1
 improves blood sugar after food intake through multiple effects that work
 in concert on the intestine, liver, pancreas and brain(3). BYETTA is
 approved by the FDA for use by people with type 2 diabetes who are
 unsuccessful at controlling their blood sugar levels despite using the
 commonly prescribed oral medications metformin, a sulfonylurea, or a
 thiazolidinedione. For full prescribing information, visit www.BYETTA.com.
     About Diabetes
     Diabetes affects more than 20 million in the United States and an
 estimated 194 million adults worldwide(4)(5). Approximately 90-95 percent
 of those affected have type 2 diabetes. People who have type 2 diabetes
 either do not produce enough insulin and/or the cells in the body do not
 respond normally to insulin. Diabetes is the fifth leading cause of death
 by disease in the United States and costs approximately $132 billion per
 year in direct and indirect medical expenses(6). Type 2 diabetes usually
 occurs in adults over the age of 40, but is increasingly common in younger
     According to the Centers for Disease Control and Prevention's National
 Health and Nutrition Examination Survey, approximately 60 percent of people
 with diabetes do not achieve target A1C levels (the target is less than
 7.0%, according to American Diabetes Association guidelines) with their
 current treatment regimen(7).
     Important Safety Information for BYETTA(R) (exenatide) injection
     BYETTA improves blood sugar control in patients with type 2 diabetes
 who are taking metformin, a sulfonylurea, a thiazolidinedione, a
 combination of metformin and a sulfonylurea, or a combination of metformin
 and a thiazolidinedione, but have not achieved adequate glycemic control.
 BYETTA is not a substitute for insulin in patients whose diabetes requires
 insulin treatment. BYETTA is not recommended for use in patients with
 problems digesting food or those who have severe disease of the stomach or
 kidney. Before using BYETTA, patients should tell their healthcare provider
 if they are pregnant, plan to become pregnant, or are breastfeeding. BYETTA
 has not been studied in children.
     Sulfonylureas, commonly used products among patients with type 2
 diabetes, can cause hypoglycemia (low blood sugar). Therefore, when BYETTA
 is used with a medicine that contains a sulfonylurea, there is an increased
 risk of this possible side effect. To reduce this possibility, the dose of
 sulfonylurea medicine may need to be reduced while using BYETTA. Other
 common side effects with BYETTA include nausea, vomiting, diarrhea,
 dizziness, headache, feeling jittery, and acid stomach. Nausea is most
 common when first starting BYETTA, but decreases over time in most
 patients. BYETTA may reduce appetite, the amount of food eaten, and body
 weight, however no changes in dose are needed for these side effects. These
 are not all the side effects with BYETTA. A healthcare provider should be
 consulted about any side effect that is bothersome or does not go away.
     For complete safety profile and other important prescribing
 considerations, visit www.BYETTA.com.
     About Amylin and Lilly
     Amylin Pharmaceuticals is a biopharmaceutical company committed to
 improving lives through the discovery, development and commercialization of
 innovative medicines. Amylin has developed and gained approval for two
 first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate)
 injection and BYETTA(R) (exenatide) injection. Amylin's research and
 development activities leverage the company's expertise in metabolism to
 develop potential therapies to treat diabetes, obesity and cardiovascular
 disease. Amylin is located in San Diego, California with over 1,500
 employees nationwide. Further information on Amylin Pharmaceuticals is
 available at www.amylin.com.
     Through a long-standing commitment to diabetes care, Lilly provides
 patients with breakthrough treatments that enable them to live longer,
 healthier and fuller lives. Since 1923, Lilly has been the industry leader
 in pioneering therapies to help health care professionals improve the lives
     people with diabetes, and research continues on innovative medicines to
 address the unmet needs of patients. For more information about Lilly's
 current diabetes products visit www.lillydiabetes.com.
     Lilly, a leading innovation-driven corporation, is developing a growing
 portfolio of first-in-class and best-in-class pharmaceutical products by
 applying the latest research from its own worldwide laboratories and from
 collaborations with eminent scientific organizations. Headquartered in
 Indianapolis, Ind., Lilly provides answers -- through medicines and
 information -- for some of the world's most urgent medical needs.
 Additional information about Lilly is available at www.lilly.com.
     This press release contains forward-looking statements about Amylin and
 Lilly. Actual results could differ materially from those discussed or
 implied in this press release due to a number of risks and uncertainties,
 including the risk that additional indications for BYETTA may not be
 received and/or that BYETTA may be affected by unexpected new data or
 technical issues. The potential for BYETTA may also be affected by
 competition, government and commercial reimbursement and pricing decisions,
 the pace of market acceptance and any issues related to manufacturing and
 supply. These and additional risks and uncertainties are described more
 fully in Amylin's and Lilly's most recently filed SEC documents such as
 their Quarterly Reports on Form 10-Q. Amylin and Lilly undertake no duty to
 update these forward-looking statements.
     (1) Bernard Zinman, Byron Hoogwerf, Santiago Duran Garcia, Denai Milton,
         Joseph Giaconia, Dennis Kim, Michael Trautmann, Robert Brodows.
         "Safety and Efficacy of Exenatide in Patients with Type 2 Diabetes
         Mellitus Using Thiazolidenediones with or without Metformin." Abstract
         presented at ADA 2006.
     (2) Amylin Pharmaceuticals and Eli Lilly and Company press release.
         "BYETTA(R) Shown to Reduce Blood Glucose Levels When Added to Patients
         Using a TZD." Available at http://www.prnewswire.com/cgi-
         006/0004378069&EDATE=Jun+10,+2006. Accessed November 13, 2006.
     (3) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor
         K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4 (exenatide)
         significantly reduces postprandial and fasting glucose in subjects
         with type 2 diabetes. Journal of Clinical Endocrinology & Metabolism.
         2003; 88(7):3082-3089.
     (4) The International Diabetes Federation Diabetes Atlas. Available at:
         87B73F80BC22682A. Accessed April 12, 2005.
     (5) "All About Diabetes." American Diabetes Association. Available at
         http://www.diabetes.org/about-diabetes.jsp. Accessed November 9, 2006.
     (6) "Direct and Indirect Costs of Diabetes in the United States." American
         Diabetes Association. Available at http://www.diabetes.org/diabetes-
         statistics/cost-of-diabetes-in-us.jsp. Accessed November 9, 2006.
     (7) Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and
         ethnic differences in glycemic control of adults with type 2 diabetes.
         Diabetes Care. 1999;22:403-408.

SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company