AMLN Amylin Pharmaceuticals, Inc. (MM)

Amylin Pharmaceuticals, Inc. (AMLN) recently completed the submission of its rolling Biologics License Application (BLA) for metreleptin to the US Food and Drug Administration (FDA).

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.

Amylin had initiated the filing of the rolling BLA for metreleptin in December 2010. The company started off with the filing of the clinical and non-clinical sections. With the chemistry, manufacturing, and controls (CMC) section being submitted, the company has now completed the BLA submission.

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. Given the severity and rare nature of the disease, metreleptin received both orphan drug status as well as fast track designation from the FDA.

Amylin has 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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