Amylin (AMLN), Alkermes (ALKS), Lilly (LLY) Report Strong Data from BYDUREON DURATION-3 and -4

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS), report new analyses from the DURATION-3 and -4 trials demonstrating patients treated with the investigational medication BYDUREON (exenatide extended-release for injectable suspension) experienced significant improvements in select cardiovascular risk factors, in comparison to patients who received commonly prescribed diabetes treatments. The analyses showed that patients receiving BYDUREON for the treatment of type 2 diabetes experienced improvements in composite endpoints related to body weight, abnormal blood pressure and abnormal lipid levels.

Results from the release:

"Patients participating in the DURATION-3 study received BYDUREON or Lantus® (insulin glargine) in addition to metformin or metformin plus a sulfonylurea. Interim results from the study's ongoing extension found that patients receiving BYDUREON and completing 84 weeks of therapy:

• Demonstrated statistically significant reduction in body weight (vs. Lantus; treatment difference: 9.8 pounds).

Also, statistically significantly more patients in the BYDUREON treatment arm:

• Met a composite endpoint of A1C <7 percent plus target systolic blood pressure (<130 mmHg) and LDL cholesterol (<100 mg/dL) (15.7 percent vs. 7.9 percent with Lantus); and
  
  
• Met a composite endpoint of A1C less than or equal to 6.5 percent plus target systolic blood pressure (<130 mmHg) and LDL cholesterol (<100 mg/dL) (11.2 percent vs. 5.1 percent with Lantus).
  
  Drug-naive patients with type 2 diabetes participating in the DURATION-4 trial were randomized to one of four treatment arms: BYDUREON, metformin, Actos® (pioglitazone HCI) and Januvia® (sitagliptin). The post-hoc analyses showed patients treated with BYDUREON or metformin were more likely to achieve clinically relevant composite goals than patients treated with Actos or Januvia. Researchers evaluated how many patients in each treatment group:
  • Achieved a composite endpoint of A1C <7 percent, no weight gain and no minor or major hypoglycemia (48 percent for BYDUREON vs. 22 percent for Actos, 35 percent for Januvia and 46 percent for metformin); and
    
    
  • Reached a composite endpoint of A1C <7 percent plus target systolic blood pressure (<130 mmHg) and target LDL cholesterol (<100 mg/dL) (16 percent for BYDUREON vs. 10 percent for Actos, 7 percent for Januvia and 13 percent for metformin).
  In the DURATION-3 study, gastrointestinal adverse events were among those most commonly reported; however, the number of new cases of all adverse events declined during the extension phase of the trial. In the DURATION-4 study, the most frequently reported adverse events among BYDUREON users were nausea and diarrhea. These data are consistent with the previously reported profiles of BYDUREON and BYETTA (exenatide) injection."

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