Three companies involved in the development of a once-weekly injection of the Type 2 diabetes drug exenatide reported today that the treatment did not provide superior efficacy over an existing treatment in a head-to-head study.
Amylin Pharmaceuticals (NASDAQ:AMLN) of San Diego, Waltham, MA-based Alkermes (NASDAQ:ALKS), and Indianapolis drugmaker Eli Lilly (NYSE:LLY) said that the treatment, called Bydureon, failed to meet its primary endpoint in a 26-week “noninferiority” study comparing it to Novo Nordisk’s liraglutide (Victoza). Patients on the weekly exenatide formulation had only a 1.3 percent decrease in a blood marker called A1C compared with a 1.5 percent decrease among patients who took liraglutide in the study. Yet patients who received Bydureon generally suffered fewer side effects than those who took liraglutide.
The results follow the FDA’s complete response to an application for approval of Bydureon in October 2010, when the once-weekly treatment failed to gain approval. (A twice-a-day version of exenatide, marketed as Byetta, is Amlylin’s top seller. The agency asked for additional data on Bydureon’s impact on heart rhythms. The companies involved in developing the treatment plan to file a response to the FDA in the second half of 2011.
This latest study, dubbed DURATION-6, is the sixth trial comparing weekly exenatide to other treatments for Type 2 diabetes. (The study is not going to be part of the submission packages for U.S. or European approval of the treatment, according to Alkermes.) In the study, Amylin and its collaborators pitted their once-a-week treatment against a product that has gained market share from Amylin and Lilly’s twice-daily version of exenatide since Novo Nordisk won FDA approval of liraglutide, a once-a-day treatment, in January 2010.
Both exenatide and liraglutide are drugs known as GLP-1 receptor agonists, but Bydureon’s developers hope that once-a-week formulation will provide greater convenience for patients with Type 2 diabetes. (Read my colleague Luke Timmerman’s recent interview with Amylin CEO Dan Bradbury for more about his company’s hopes for the weekly version of exenatide.)
So what does the failure of the treatment to meet the study’s primary endpoint mean for its regulatory and commercial chances? “DURATION-6 was not a pivotal trial, and given that Bydureon showed robust A1C reduction with no new safety issues, we see little impact to Bydureon’s approval chances,” JP Morgan said in a note to investors this morning. “However, with Bydureon potentially reaching the US market two-plus years after Victoza and a numerically better A1C drop for Victoza from (the DURATION-6 trial), we foresee potentially significant adverse commercial implications from this study.”
Amylin’s share price had fallen by 22.5 percent to $11.64 per share as of 12:12 pm Eastern time. Amylin has been viewed as the company with the most at stake with Bydureon. Alkermes’ stock price was down 12 percent to $12.40 per share as of 12:11 pm Eastern time. Alkermes provides the polymer microsphere technology that enables the extended release of exenatide. Alkermes would get an 8 percent royalty on sales of the once-weekly treatment if it is approved. Lilly’s shares were listed at $34.48, up .3 percent as of 12:13 pm Eastern.
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