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.
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