Amylin shares plunge as FDA panel rejects lead drug candidate, Symlin

Amylin Pharmaceuticals has suffered a massive blow after a decision bythe US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted against approval of the company's lead drug candidate Symlin (pramlintide acetate), sending its shares plummeting.

This news is the latest in a series of knocks suffered by Symlin, an analog of the human hormone amylin which is secreted by beta cells in the pancreas. The drug, which is produced by Switzerland-based Bachem, is being developed as an adjunct to insulin with the aim of improving glucose control, reducing the dose of insulin required by diabetic patients and combating the extreme weight gain caused by insulin therapy.

Symlin was initially developed under a three-year collaboration with Johnson & Johnson, but three years ago the latter firm terminated the deal, saying that Symlin did not fit into its portfolio (Marketletters passim). Since then, Amylin, which has also submitted a European marketing authorization application for Symlin (Marketletter June 11).