Amylin clears regulator hurdle and reports much better than expected earnings Print
By Staff and Wire Reports   
Friday, 21 October 2011 04:38
biotech investingShares of Amylin Pharmaceuticals (NASDAQ:AMLN) jumped over 13% and closed at $11.55 +1.31 (12.79%) - the most in more than six months after its Byetta drug developed with Eli Lilly & Co. (NYSE:LLY) won expanded approval for use with the world’s top-selling insulin to treat Type 2 diabetes. Amylin announced third-quarter financial results late yesterday, posting a loss of seven cents a share, compared to a loss of 31 cents a share during the same quarter last year. Net sales totaled $155 million.

Shares of the stock continued slightly higher after hours following a decision from Food and Drug Administration regulators to clear the injectable medicine, first approved in April 2005, to be used by patients taking insulin glargine, a long-acting insulin marketed by French drugmaker Sanofi as Lantus, Amylin and Lilly said yesterday in a statement.The move would “make Byetta available to millions of insulin-using Type 2 diabetes patients in the United States,” Vincent Mihalik, senior vice president of sales and marketing at Amylin, said in an April earnings call.   

Byetta stimulates pancreas cells to produce insulin when blood sugar is high. It has been approved for patients taking other diabetes medicines and on its own as a therapy with diet and exercise.

The drug brought in $559 million for San Diego-based Amylin last year, almost 85 percent of the company’s revenue, according to data Bloomberg compiled. The drug accounted for $151 million in sales for Indianapolis-based Lilly last year.

Amylin sued Lilly in federal court alleging anticompetitive activity and breach of a strategic alliance agreement, the company said in a statement in May. Amylin wants to stop Lilly from using the same sales force to promote linagliptin, a product Lilly is developing with German drugmaker Boehringer Ingelheim GmbH to complete with Byetta and a once-weekly version called Bydureon under review by the FDA.

Investors might expect the stock price to increase given the firm's financial results.  In fact,  During the third quarter, Amylin reported revenue of $175.0 million and a smaller loss per share of just $0.09. Both revenue and earnings per share were significantly better than expected.

Amylin has been struggling to win FDA approval for Bydureon, a once-weekly version of Byetta, which the agency has rejected twice.  The FDA has set Jan. 28 as the review date for that drug.

Amylin Pharmaceuticals' research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. It's Research and Development is focused on novel peptide hormones and their therapeutic potential for millions of people coping with diabetes, obesity, and other metabolic diseases. The discovery process is designed to identify unknown peptide hormones.

Amylin Pharmaceuticals' product pipeline includes: Symlin® (pramlintide acetate) injection for the treatment of type 1 and 2 diabetes, a first-in-class diabetes therapy offering improved glucose control with potential for weight loss; BYETTA® (exenatide) injection, a first-in-class type 2 diabetes therapy offering powerful, sustained A1C reductions with potential weight loss; Exenatide transdermal patch, an investigational product designed to be applied once per day to provide sustained levels of exenatide for people with type 2 diabetes; Metreleptin, an analog of human leptin, a neurohormone secreted by fat cells that plays a fundamental role in the regulation of energy homeostasis, fat and glucose metabolism and body weight; etc.




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