Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Co. (LLY) and Alkermes, Inc. (ALKS) recently submitted a response to the US Food and Drug Administration (FDA) regarding the complete response letter on pipeline candidate, Bydureon (exenatide once-weekly).
The companies are seeking to get Bydureon approved for the treatment of type II diabetes. In mid-March, the FDA had issued a complete response letter asking the companies to finalize the label and provide a Risk Evaluation and Mitigation Strategy (REMS) and clarification on existing manufacturing processes.
However, we were pleased to note that the FDA did not ask Amylin, Lilly, and Alkermes to conduct additional studies as this would have delayed approval significantly. We were concerned that safety issues surrounding the use of glucagon-like peptide-1 (GLP-1) molecules like exenatide could have led to the FDA asking for additional safety studies.
Amylin, Lilly, and Alkermes have addressed the issues raised by the FDA in its complete response letter. The agency will inform the companies within two weeks whether the resubmission will be treated as a class I or II review. Depending on the classification, a decision from the FDA should be out 2-6 months after the response is submitted.
Meanwhile, Lilly has submitted an application seeking regulatory approval for Bydureon in the EU. A response should be out by mid 2011.
Once launched, Bydureon will face competition from Novo Nordisk’s (NVO) Victoza, a once-daily injection that was launched recently. Other GLP-1 molecules under development include GlaxoSmithKline’s (GSK) Syncria (albiglutide) and Roche (RHHBY)/Ipsen’s taspoglutide. We note that Glaxo’s Syncria, currently in a phase III program, is also a once-weekly injection.
We currently have a Neutral recommendation on Amylin. We expect investor focus to remain on Byetta’s performance and the approvability of Bydureon, potentially later this year. We believe that the final label for Bydureon is likely to contain warnings regarding the risk of pancreatitis and thyroid cancer. Looking forward, we are optimistic on the mid-stage obesity pipeline. We view Amylin’s deal with Takeda for the obesity pipeline as a major positive.
Read the full analyst report on “AMLN”
Read the full analyst report on “LLY”
Read the full analyst report on “ALKS”
Read the full analyst report on “NVO”
Read the full analyst report on “GSK”
Read the full analyst report on “RHHBY”
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