Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS) recently presented positive phase II data on a once-monthly injectable suspension formulation of exenatide.
Results from the randomized, open-label study, which was conducted with 121 type II diabetes patients, showed that patients in the exenatide once-monthly arm achieved a reduction of 1.3-1.5 percentage points in A1C levels. Amylin and its partners also evaluated Bydureon (exenatide once-weekly) which achieved 1.5 percentage point reduction in A1C levels.
Amylin, Lilly and Alkermes are now planning to meet with regulatory authorities to determine the forward development path for exenatide once-monthly.
The positive data comes a few days after Amylin reported disappointing results on Bydureon from a head-to-head study. Earlier this month, Amylin had reported that Bydureon failed to achieve its primary endpoint of non-inferiority in the DURATION-6 study, which compared Bydureon with Novo Nordisk’s (NVO) Victoza.
The disappointing DURATION-6 data was the latest setback faced by Amylin and its partners in the development of Bydureon. Earlier in October 2010, Bydureon’s approval was delayed with the US Food and Drug Administration (FDA) issuing a second complete response letter (CRL) for the type II diabetes candidate.
In its second CRL, the FDA asked the companies to conduct a thorough QT (tQT) study. The FDA may have asked for this study based on the recent concerns raised regarding the cardiovascular safety profile of diabetes drugs.
The agency 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).
Amylin and its partners intend to submit a response to the second CRL in the second half of 2011. Assuming a six-month review period, Bydureon could gain FDA approval in mid 2012.
Neutral on Amylin
We currently have a Neutral recommendation on Amylin, which is supported by a Zacks #3 Rank (short-term Hold recommendation). We expect investor focus to remain on Byetta’s performance and updates on the approval process for Bydureon. Longer-term, we are optimistic on the mid-stage obesity pipeline. Amylin’s deal with Takeda for the obesity pipeline is a major positive.
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