AMLN Amylin Pharmaceuticals, Inc. (MM)

Amylin Pharmaceuticals, Inc. (AMLN) and its partners, Eli Lilly and Company (LLY), and Alkermes, Inc. (ALKS), recently presented results from a thorough QT (tQT) study with exenatide.

The study was conducted in accordance with the US Food and Drug Administration’s (FDA) requirements for the New Drug Application (NDA) for Bydureon (exenatide once-weekly).

The study evaluated the potential of exenatide to increase the QT interval across a wide range of plasma concentrations. The study, which used multiple heart rate correction methodologies, met the pre-specified primary endpoint.

Data showed that exenatide, when administered at and above therapeutic levels, did not prolong the corrected QTc interval in healthy individuals. Moreover, there was no relationship between QTc interval and plasma exenatide concentrations.

Shares of both Amylin and Alkermes reacted positively to the tQT data.

Amylin, Alkermes and Eli Lilly are looking to get Bydureon approved for the treatment of type II diabetes. However, the regulatory path for Bydureon has not been smooth in the US where it has already received two complete response letters (CRLs) from the FDA.

In addition to asking the companies to conduct the tQT study, the FDA has also asked Amylin and its partners to submit data from the DURATION-5 study, which was conducted to compare the safety and efficacy of Bydureon versus Byetta (exenatide).

With the tQT study meeting its primary endpoint, Amylin and its partners intend to submit a response to the second CRL in the third quarter of 2011. Approval could come early next year. We note that Bydureon gained approval in the EU in June 2011.

We currently have Neutral recommendations on Eli Lilly, Amylin and Alkermes.

 
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