Amylin to take Symlin back to clinic

Amylin Pharmaceuticals has said it will conduct additional clinicaltrials of its candidate drug for diabetes, Symlin (pramlintide acetate), with a view to filing an amendment to its regulatory submission for the drug in the second half of 2002. The additional trials were a condition of an approvable letter from the US Food and Drug Administration, which the company received last October (Marketletter October 22).

News of the decision sparked a near 10% decline in Amylin's share price on the day of the announcement (December 27) to $8.81.

Amylin said it now plans to conduct a 250-patient trial of Symlin in conjunction with insulin in type 1 diabetics, in order to answer questions about reported cases of severe hypoglycemia with the combination in these patients. Concern about these cases of hypoglycemia, which seemed to occur on initiation of therapy, was the main reason for the drug failing to get through an FDA advisory committee meeting to review the clinical data last summer (Marketletter August 6).