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Alkermes Inc. shares popped Monday on news that federal regulators responded positively to a new diabetes-drug application filed by the Waltham-based biotechnology firm and its development partners, Amylin Pharmaceuticals Inc. and Eli Lilly and Co.
Alkermes (Nasdaq: ALKS) disclosed in a regulatory filing Monday that the U.S. Food and Drug Administration said additional clinical information would not be needed in its review of Bydureon, an extended-release, once-weekly medication designed to control glycemic levels in type 2 diabetes patients.
Bydureon is the branded label assigned to the once-weekly version of exenatide, the active ingredient in an already approved injection-therapy for diabetes patients.
Alkermes said the FDA has requested more information regarding labeling as well as the drug’s manufacturing process. The company also said there were no issues raised concerning the FDA’s inspection of an Ohio-based manufacturing site where the drug would be made.
The FDA’s response was expected Mar. 7, but heavy snowstorms that bogged down Washington, D.C., in February prompted the agency to delay the release of its findings.
Alkermes shares jumped 13 percent to over $13.80 a share in late trading Monday. Amylin Pharmaceuticals (Nasdaq: AMLN) jumped 16 percent while Eli Lilly and Co. (NYSE: LLY) was relatively flat at $35.92 a share.
“This is a significant step forward in our ability to bring this important therapy to patients,” said Amylin Senior Vice President of Research and Development Orville G. Kolterman. “We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks.”
The new drug application for Bydureon was filed in May 2009 and accepted by the FDA in July, according to Alkermes.
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