Amylin Pharmaceuticals, Inc.
) 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
According to the company, lipodystrophy is estimated to affect
about 1,000 people in the US and 3,000 in other major markets for
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
). 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
Amylin could be an attractive takeover target for companies with
a focus on the diabetes market.
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