Update on Amylin's Metreleptin - Analyst Blog
June 19 2012 - 11:31AM
Zacks
Amylin Pharmaceuticals, Inc. (AMLN) recently
provided an update on its regulatory status for metreleptin. In an
8K filing with the US Securities and Exchange Commission (SEC),
Amylin said that the US Food and Drug Administration (FDA) has
asked for updated data on metreleptin from the submitted clinical
studies that are currently ongoing.
Amylin had completed the submission of its rolling Biologics
License Application (BLA) for metreleptin in April 2012.
Amylin is looking to get metreleptin approved for the treatment
of diabetes and/or high levels of triglycerides in the bloodstream
(hypertriglyceridemia) in pediatric and adult patients suffering
from rare forms of lipodystrophy.
The company had initiated the filing of the rolling BLA for
metreleptin in December 2010. Amylin started off with the filing of
the clinical and non-clinical sections. The chemistry,
manufacturing, and controls (CMC) section was submitted in April
2012.
According to the company, lipodystrophy is estimated to affect
about 1,000 people in the US and 3,000 in other major markets for
orphan drugs.
The company is currently in discussions with the agency
regarding its requirements and expects to respond to the FDA’s
request on a timely basis so that the agency will be able to
complete its evaluation of the rolling BLA submission. We note that
Amylin had asked for priority review which, if granted, could
result in a response regarding FDA approvability by year end.
Neutral on Amylin
We currently have a Neutral recommendation on Amylin, which
carries a Zacks #3 Rank (short-term Hold rating). The company was
in the news recently with rumors circulating regarding a take-over
bid by Bristol-Myers Squibb (BMY). According to
Bloomberg, which cited unnamed sources, Bristol-Myers had made an
offer of $22 per share ($3.5 billion). However, the offer was said
to have been rejected by Amylin’s board of directors.
Amylin could be an attractive takeover target for companies with
a focus on the diabetes market.
AMYLIN PHARMA (AMLN): Free Stock Analysis Report
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