Amylin Provides Strategy Update - Analyst Blog
January 10 2012 - 8:36AM
Zacks
Amylin Pharmaceuticals, Inc. (AMLN) recently
presented an update on its strategy for 2012 at the 30th Annual
J.P. Morgan (JPM) Healthcare Conference.
Amylin has a big regulatory event coming up later this month,
with the US Food and Drug Administration (FDA) expected to deliver
a decision on its type II diabetes candidate, Bydureon (exenatide
once-weekly). While Bydureon gained approval in the EU in 2011, the
US regulatory path for the candidate has not been smooth with the
FDA issuing two "complete response" letters.
Amylin is set for the potential US launch of Bydureon in the
first quarter of 2012. The company intends to have two commercial
units -- one focused on exenatide and the other on specialty and
orphan diseases.
While the exenatide team will consist of 650 diabetes sales
specialists, the specialty and orphan disease team will initially
focus on promoting Symlin. However, we note that once launched,
Bydureon will face intense competition from Novo
Nordisk’s (NVO) Victoza, which already has a significant
head-start in the GLP-1 market.
Amylin also intends to commence a phase III study with a
once-weekly suspension formulation of exenatide in mid-2012. A
phase III program for the monthly suspension formulation of
exenatide is scheduled to commence in 2013.
Amylin is looking to further strengthen its exenatide franchise
by focusing on driving Byetta (exenatide) sales. The company, which
terminated its exenatide agreement with Eli Lilly and
Company (LLY) in November 2011, is currently looking for
an ex-US partner. Partnering exenatide should maximize the value of
the product.
As far as metreleptin is concerned, the company intends to
finish submitting a rolling biologics license application (“BLA”)
for the use of metreleptin for the treatment of diabetes and/or
hypertriglyceridemia in patients suffering from rare forms of
lipodystrophy in the first half of 2012. Approval could result in
the product launch in 2013.
Besides working on advancing its pipeline, Amylin said that it
intends to continue working on controlling costs. Although the
company expects to spend an additional $150 million - $170 million
in cash operating expenses on the Bydureon launch, a major part of
the expenses will be funded by improved gross profit economics.
Neutral on Amylin
We currently have a Neutral recommendation on Amylin, which
carries a Zacks #3 Rank (short-term Hold rating). Amylin has had
its share of ups and downs over the past few quarters. While the EU
approval of Bydureon was a positive for the company, the delay in
gaining FDA approval for the candidate has weighed on the stock.
Byetta’s performance has also been disappointing.
Bydureon’s US approval would be a major boost for Amylin.
However, it remains to be seen whether it will be third time's the
charm for Bydureon on Jan 28, 2012 (the FDA action date).
AMYLIN PHARMA (AMLN): Free Stock Analysis Report
JPMORGAN CHASE (JPM): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
NOVO-NORDISK AS (NVO): Free Stock Analysis Report
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