Amylin Pharmaceuticals, Inc. (AMLN) recently announced positive results on its once weekly formulation of Byetta (referred to as exenatide once weekly), which is being developed in collaboration with Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS).
Amylin presented results from a head-to-head study (DURATION-5) comparing exenatide once weekly with a Byetta injection taken twice daily in patients with type II diabetes. Data showed that after 24 weeks of treatment, patients on exenatide once weekly experienced a statistically superior reduction in A1C, a measure of average blood sugar over three months (1.6 percentage points versus 0.9 percentage points).
While both treatment groups achieved statistically significant weight loss by the end of the study, the average loss was higher in the once-weekly group compared to the Byetta group (5.1 pounds versus 3 pounds). The most frequently reported adverse event in both was nausea, which was reported less frequently in the exenatide once-weekly group (14% versus 35%).
The Amylin study results are in-line with previously reported data on both exenatide once weekly and Byetta. Data from the DURATION-1 study, which compared exenatide once weekly with Byetta, showed 77% (compared to 61% for patients on Byetta) of patients treated with exenatide once weekly achieved an A1C of 7% or less.
Earlier this year, Amylin presented results from two other studies — DURATION-2 and DURATION-3. While DURATION-2 showed that exenatide once weekly offers a very favorable efficacy and safety profile when compared to leading oral therapies such as Merck’s (MRK) Januvia and Takeda’s Actos, the DURATION-3 study proved exenatide once weekly to be superior to Sanofi-Aventis’ (SNY) Lantus.
Besides solid efficacy, exenatide once weekly also offered a significant weight loss benefit advantage over both Januvia and Actos. Amylin intends to conduct yet another study with exenatide once weekly called DURATION-6, which will examine the efficacy, safety and tolerability of exenatide once weekly head-to-head with Novo Nordisk’s (NVO) liraglutide. The superior efficacy and safety results from the DURATION studies should help exenatide once weekly gain share once launched.
Exenatide once weekly is currently being reviewed by the U.S. Food and Drug Administration (FDA); a response should be out in the first quarter of 2010. The approval and launch of the once-weekly formulation of Byetta should help drive Amylin to profitability. We currently have a Neutral recommendation on the Amylin stock.
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