Positive EU Opinion for Bydureon - Analyst Blog
April 18 2011 - 12:43PM
Zacks
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.
ALKERMES INC (ALKS): Free Stock Analysis Report
AMYLIN PHARMA (AMLN): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
NOVO-NORDISK AS (NVO): Free Stock Analysis Report
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