Amylin Pharmaceuticals Inc. priced its public offering of 10.5 million shares at $8 apiece, raising $84 million for Phase III trials of AC2993 in Type II diabetes.
The company filed a shelf registration statement in December covering up to 13.3 million shares of common stock. The joint lead managers for the offering are Goldman Sachs and Lehman Brothers Inc., both of New York. Goldman Sachs also is book-running manager. Underwriters have a 30-day option to purchase up to 1.575 million additional shares to cover overallotments. At the end of the third quarter the company had $65.8 million in cash and equivalents.
Amylin’s stock (NASDAQ:AMLN) closed Tuesday at $8.50, up 32 cents.
AC2993, a peptide shown to stimulate secretion of insulin in the presence of elevated blood glucose concentrations, except during periods of low blood glucose concentrations, was taken into the second of three Phase III trials in people with Type II diabetes in late January. The trial will include about 400 patients who will be split into three groups two will receive AC2993 and one group will get placebo, although all participants will be treated with sulfonylureas during the study. The first Phase III was initiated in December.
Amylin anticipates initiating the third Phase III sometime this quarter, examining the effects of AC2993 when added to a combination of metformin and sulfonylureas.
Amylin’s lead product, however, is Symlin, an analogue of human amylin that the company developed to treat Type I and insulin-dependent Type II diabetes patients. The product was voted down in July for both Type I and Type II diabetes by the Endocrinologic and Metabolic Drugs Advisory Committee, which said that while the drug showed efficacy, it did not appear safe. However, the FDA struck out on its own and issued Amylin an “approvable letter” for both types of diabetes in October, although calling for additional tests before it would clear the product for marketing. Amylin now is working with the FDA toward Symlin approval and has said it plans to submit the NDA amendment in the second half of this year. (See BioWorld Today, June 27, 2001, and Oct. 15, 2001.)
Also, Amylin said results from a six-week pilot study evaluating the effects of Symlin on the daily glucose profile in people with Type I diabetes who are intensively managing their diabetes with lispro or regular insulin delivered via an insulin pump showed that after four weeks, patients had increased time spent in the target glucose concentration range by 32 percent.