BYETTA(R) Study Showed Comparable Blood Glucose Control to Insulin

- BYETTA offers the added benefits of progressive weight loss and lower

risk of hypoglycemia -

    CHICAGO, June 24 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
 ( AMLN) and Eli Lilly and Company ( LLY) today announced study
 results comparing treatment with BYETTA(R) (exenatide) injection with
 insulin glargine in people with type 2 diabetes. Study findings showed
 comparable improvements in blood sugar control with BYETTA and insulin
 glargine therapies, with weight loss and lower incidence of hypoglycemia
 associated with BYETTA. Patients in the study were also taking one of two
 commonly used oral medications. These findings were presented at the 67th
 Annual Scientific Sessions of the American Diabetes Association (ADA) in
 Chicago.
     This open-label crossover study of 114 people with type 2 diabetes
 compared treatment with BYETTA (5 mcg for 4 weeks and 10 mcg for 12 weeks)
 and oral medication (metformin or a sulfonylurea) with treatment with
 insulin glargine and oral medication on measures of blood sugar control,
 weight change and incidence of hypoglycemia during two 16-week periods.
 Treatment with BYETTA resulted in blood sugar control (measured by A1C
 reductions) comparable to treatment with insulin glargine (-1.43 percent
 vs. -1.41 percent, respectively).(1)
     However, BYETTA treatment with metformin resulted in statistically
 significant lower risk of hypoglycemia (2.6 percent) than treatment with
 insulin glargine and metformin (17.4 percent). Additionally, there were
 seven episodes of severe hypoglycemia in three patients taking insulin
 glargine and no severe episodes during treatment with BYETTA, reflecting a
 lower overall risk of hypoglycemia. BYETTA treatment was also associated
 with a 5.7-pound weight loss from baseline, compared with a 1.3-pound
 weight gain among individuals in the insulin glargine group (a 7.0-pound
 difference between groups).
     "Adding BYETTA to oral medication to achieve target blood sugar control
 levels can be an important next step in the management of type 2 diabetes,"
 said Michael Trautmann, MD, lead investigator of this study and Medical
 Fellow of Eli Lilly and Company. "This study shows that adding BYETTA to
 oral medication before insulin use may help people with type 2 diabetes
 obtain the same glucose control as insulin and yet lose weight with reduced
 risk of hypoglycemia."
     BYETTA was generally well-tolerated in this study, and side effects
 were consistent with those seen in previous studies. In clinical trials and
 post- approval adverse event reports, the most common side effect is
 mild-to- moderate nausea, which affects fewer than half of patients and
 usually decreases over time.
     BYETTA is indicated for use as an adjunctive therapy for people with
 type 2 diabetes who are not achieving blood sugar control using metformin,
 a sulfonylurea, or a thiazolidinedione. Over three million prescriptions
 have been written in the U.S. since being approved by the Food and Drug
 Administration (FDA) in 2005.
     For more information, visit www.BYETTA.com.
     About BYETTA
     BYETTA is the first in a class of drugs called incretin mimetics for
 the treatment of type 2 diabetes. 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 stomach, liver, pancreas and brain. BYETTA is approved by
 the FDA for use by people with type 2 diabetes who are unsuccessful at
 controlling their blood sugar levels. BYETTA is an add-on therapy for
 people currently using metformin, a sulfonylurea, or a thiazolidinedione.
 BYETTA provides sustained A1C control, low incidence of hypoglycemia when
 used with metformin or a thiazolidinedione, and progressive weight loss.
 For full prescribing information, visit www.BYETTA.com.
     Safety and Tolerability
     BYETTA improves glucose (blood sugar) control in patients with type 2
 diabetes who are taking metformin, a sulfonylurea, or a thiazolidinedione.
 BYETTA is not a substitute for insulin in patients whose diabetes requires
 insulin treatment. BYETTA is not recommended for use in patients with
 severe problems with the stomach or food digestion, or those who have
 severe kidney disease. 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.
     When BYETTA is used with a medicine that contains a sulfonylurea,
 hypoglycemia (low blood sugar) is a 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. 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.
     About Diabetes
     Diabetes affects more than 20 million in the United States and an
 estimated 246 million adults worldwide.(2,3) Approximately 90-95 percent of
 those affected have type 2 diabetes. 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.(4)
     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 their target blood sugar levels with their
 current treatment regimen.(5)
     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. Amylin's research and development
 activities leverage the company's expertise in metabolism to develop
 potential therapies to treat diabetes and obesity. Amylin is located in San
 Diego, California with over 1,600 employees nationwide. For more
 information about Amylin and the company's diabetes products, visit
 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
 of 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, Indiana, 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 BYETTA and the revenues generated from BYETTA may
 be affected by competition, unexpected new data, technical issues, clinical
 trials not confirming previous results or predicting future results, label
 expansion requests not being submitted in a timely manner or receiving
 regulatory approval, or manufacturing and supply issues. The potential for
 BYETTA may also be affected by government and commercial reimbursement and
 pricing decisions, the pace of market acceptance, or scientific, regulatory
 and other issues and risks inherent in the commercialization of
 pharmaceutical products. These and additional risks and uncertainties are
 described more fully in Amylin 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.
     P-LLY
 
     REFERENCES
     1. Trautmann ME., Burger J., Johns D., Brodows R., Okerson T., Roberts A.,
        and Barnett A. Less hypoglycemia with exenatide versus insulin
        glargine, despite similar HbA1c improvement, in patients with T2DM
        adjunctively treated with metformin. Abstract # 0172-OR.
     2. The International Diabetes Federation Diabetes Atlas. Available at:
 http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A
 .
        Accessed June 14, 2007.
 
     3. "All About Diabetes." American Diabetes Association. Available at:
        http://www.diabetes.org/about-diabetes.jsp. Accessed June 14, 2007.
 
     4. "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 June 14, 2007.
 
     5. Saydah SH, Fradkin J, Cowie CC. "Poor Control of Risk Factors for
        Vascular Disease Among Adults with Previously Diagnosed Diabetes."
        JAMA. 2004: 291(3), 335-342.
 
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SOURCE Eli Lilly and Company