Amylin Pharmaceuticals, Inc. (AMLN) suffered yet another pipeline setback with the company and its partner Takeda Pharmaceutical Company Limited announcing 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 evaluate a new antibody-related laboratory finding associated with metreleptin in two patients.
Amylin and Takeda intend to investigate the finding and discuss the future development path with regulatory agencies and outside experts.
String of Pipeline Setbacks
This is the latest stumbling block faced by Amylin in the last few months. Earlier this month, Amylin’s shares lost more than 25% when the company released disappointing data on lead pipeline candidate, Bydureon (exenatide once-weekly), 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 Company (LLY) and Alkermes, Inc. (ALKS), 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). The setback with the obesity pipeline is a blow for the company and is likely to increase concerns regarding long-term growth prospects.
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