DURATION-1 Data Presented at the 68th Annual Scientific Sessions of the American Diabetes Association

SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY), and Alkermes, Inc.(Nasdaq: ALKS) announced results from a 30-week study that compared theefficacy of exenatide once weekly, a long-acting release formulation ofexenatide, to BYETTA(R) (exenatide) injection. Type 2 diabetes patientstreated with exenatide once weekly, an investigational therapy, showedstatistically significant improvements in A1C (-1.9%+/-0.08 (LS mean+/-SE))and fasting plasma glucose (FPG -42+/-3 mg/dL) from baseline and compared withBYETTA (-1.5%+/-0.08, A1C and -25+/-3 mg/dL, FPG). Patients in both treatmentgroups also reported significant weight loss (average of 8 pounds) and 77percent of patients treated with exenatide once weekly achieved an A1C of 7percent or less. These findings were presented at the 68th Annual ScientificSessions of the American Diabetes Association (ADA) in San Francisco.

BYETTA is indicated as adjunctive therapy to improve glycemic control inpatients with type 2 diabetes mellitus who are taking metformin, asulfonylurea, a thiazolidinedione, a combination of metformin and asulfonylurea, or a combination of metformin and a thiazolidinedione but havenot achieved adequate glycemic control.

'We know that a substantial number of type 2 diabetes patients areoverweight, and conventional diabetes therapies, while controlling bloodglucose, may have little or no beneficial impact on body weight. Importantly,the DURATION-1 results suggested the significant, beneficial impact ofcontinuous levels of exenatide once weekly on glycemic control, andadditionally, weight loss,' said Daniel J. Drucker, M.D., Professor in theDivision of Endocrinology, Department of Medicine, of Toronto, Director of theBanting and Best Diabetes Centre.

Study Design and Findings

The Diabetes Therapy Utilization: Researching Changes in A1C, Weight andOther Factors Through Intervention with Exenatide ONce Weekly (DURATION-1)study was a 30-week, randomized, open-label study of 295 patients with type 2diabetes (baseline values: A1C 8.3%+/-1.0, FPG 169+/-43 mg/dL, weight 225+/-44lbs., BMI 35+/-5.0 kg/m2, diabetes duration 6.7+/-5.0 years; mean+/-SD) whowere treated with exenatide once weekly 2.0 mg or BYETTA twice daily asoutlined in the approved label subcutaneously. Patients in both groups whocompleted the randomized portion of the study continued in an open-endedportion of the study to receive exenatide once weekly. Patients in bothtreatment arms showed improvements in A1C from baseline. In addition,treatment with exenatide once weekly resulted in statistically significantreductions in A1C [A1C change from baseline: 1.9%+/-0.08] compared to BYETTA[A1C change from baseline: 1.5%+/-0.08 (P=0.002)].

Seventy-seven percent of patients treated with exenatide once weeklyachieved an A1C of 7 percent or less versus 61 percent for BYETTA (P=0.004).The ADA-recommended target for good glucose control is an A1C of below 7percent. For patients entering the study with a baseline A1C of 9 percent orgreater, at endpoint, 29 percent of patients treated with exenatide onceweekly achieved A1C levels of 6.5 percent or less versus 13 percent forBYETTA. Both BYETTA and exenatide once weekly treatment groups showedsignificant glycemic improvements irrespective of baseline A1C.

Treatment with exenatide once weekly also resulted in significant loweringof FPG concentrations (reductions of -42+/-3 mg/dL, exenatide once weekly; -25+/-3 mg/dL, BYETTA, P<0.0001 vs. BYETTA). Unlike the weight gain that iscommonly associated with insulin therapy and many oral diabetes medications,both BYETTA and exenatide once weekly were associated with an average weightloss of 8 pounds.

In addition to weight loss, patients treated with exenatide once weeklyexperienced the following effects on several cardiovascular risk factors,including total cholesterol (total cholesterol -11.9+/-2.3 mg/dL from baseline173 mg/dL; LDL -4.9+/-2.0 mg/dL from baseline 91.6 mg/dL; HDL -0.9+/-0.6 mg/dLfrom baseline 43.9 mg/dL) and triglycerides (15 percent improvement of meanratio of week-30 to baseline from a baseline of 166.0 mg/dL).

Exenatide once weekly uses a proprietary technology for long-actingmedications developed by Alkermes. The technology encapsulates activemedication into polymer-based microspheres that are injected into the bodywhere they degrade slowly, gradually releasing the drug in a controlled mannerto provide continuous therapeutic exenatide concentrations.

Safety Profile

Exenatide once weekly was well tolerated with nearly 90 percent ofpatients completing 30 weeks of treatment. There were no major hypoglycemiaevents regardless of background therapy.