Amylin Pharmaceuticals, Inc. (AMLN) and its partners, Eli Lilly and Company (LLY), and Alkermes, Inc. (ALKS), recently received good news regarding their pipeline candidate, Bydureon (exenatide once-weekly). Amylin, Eli Lilly and Alkermes said that Bydureon received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The CHMP issued an opinion in favor of approving Bydureon for the treatment of type II diabetes in combination with certain oral therapies.
A final decision regarding the approvability of Bydureon should be delivered by the European Commission in 2-3 months. Approval would make Bydureon the first once-weekly type II diabetes treatment in the EU.
The positive EU recommendation comes as a relief for Amylin which has recently been at the receiving end of a series of disappointing pipeline-related news. In mid-March 2011, Amylin and its partner Takeda Pharmaceutical Company Limited had announced the suspension of clinical activities associated with a phase II study of their obesity candidate.
Amylin and Takeda were studying the safety and efficacy of pramlintide/metreleptin for the treatment of obesity. However, the companies decided to voluntarily halt the trial in order to study a new antibody-related laboratory finding associated with metreleptin in two patients.
Earlier in March, Amylin’s shares lost more than 25% when the company released disappointing data on Bydureon, from a head-to-head study. Bydureon failed to achieve its primary endpoint of non-inferiority in the DURATION-6 study, which compared Bydureon with Novo Nordisk’s (NVO) Victoza.
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, Eli Lilly and Alkermes, 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. Amylin expects Bydureon to launch in the US in the first half of 2012, at which time the company expects a $ 40 million milestone payment from Eli Lilly.
Neutral on Amylin
We currently have a Neutral recommendation on Amylin, which is supported by a Zacks #3 Rank (short-term “Hold” rating). Amylin’s shares gained 16.25% on the news regarding the positive opinion from the CHMP. Amylin expects to launch Bydureon in the EU in 2011 itself and expects to earn a $ 15 million milestone for the same.
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