AMLN Amylin Pharmaceuticals, Inc. (MM)

Amylin Pharmaceuticals, Inc. (AMLN) and its partners, Eli Lilly and Company (LLY), and Alkermes, Inc. (ALKS), recently received a boost with the European Commission granting marketing authorization to Bydureon (exenatide once-weekly) for the treatment of type II diabetes.

Bydureon is the first once-weekly treatment to gain approval for type II diabetes. Approval was granted for use in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione.

EU Approval Was Expected

EU approval was expected as, earlier in April, Bydureon had received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

While anticipated, the final approval of Bydureon, nevertheless, 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.

Response to FDA to be Submitted in the Second Half of 2011

Meanwhile, the regulatory path for Bydureon has not been smooth in the US where it has already received two complete response letters (CRLs) from the Food and Drug Administration (FDA). Amylin and its partners are currently conducting a thorough QT (tQT) study with Bydureon as per the requirements of the second CRL.

The agency has 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.

Neutral on Eli Lilly, Amylin and Alkermes

We currently have Neutral recommendations on Eli Lilly, Amylin and Alkermes. Amylin stands to receive a $15 million milestone payment from Eli Lilly on the EU launch of Bydureon.

 
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