By Randall Osborne
West Coast Editor
With an advisory committee of the FDA slated to evaluate Amylin Pharmaceuticals Inc.¿s diabetes drug in July, the company said it raised $35 million in a private placement to push that program and others.
The placement included about 3.5 million newly issued shares at $10 per share, the price at which the company¿s shares (NASDAQ:AMLN) closed Friday. An existing shareholder sold another 600,000 shares, from which Amylin gets no proceeds. Lehman Brothers, of New York, acted as the sole placement agent.
Eric Shearin, manager of investor relations for San Diego-based Amylin, said the proceeds have not been allocated in specific amounts.
¿We¿ve said in the past we had enough cash to get Symlin [the diabetes drug, pramlintide acetate] to market if approved, and continue our research,¿ Shearin told BioWorld Today. ¿This will help us more comfortably execute what we had planned.¿
Symlin, a synthetic version of the hormone amylin ¿ which is secreted with insulin by beta cells in the pancreas ¿ is a potential adjunctive therapy to insulin for the treatment of people with Type I or Type II diabetes.
The new drug application for Symlin was submitted in December, after years of ups and serious downs, including a failure that led to the loss of development partner Johnson & Johnson, of New Brunswick, N.J., which in turn led to a 75 percent reduction of Amylin¿s work force. (See BioWorld Today, Aug. 19, 1997; Oct. 22, 1998; and Dec. 8, 2000.)
Cash from the placement also will go toward other products in the pipeline: AC2993 (synthetic exendin-4) and AC2993 LAR, which is the long-acting release version and is partnered with Alkermes Inc., of Cambridge, Mass.
AC2993 is a peptide with potential for Type II diabetes, Shearin said.
¿In clinical studies so far, it¿s shown to stimulate insulin secretion,¿ he said. ¿Those actions are only present during periods of high blood glucose; otherwise it shuts down completely.¿ The drug will begin Phase III studies in the second half of this year.
With AC2993 LAR, in Phase I studies, ¿you could have an injection once a month,¿ Shearin said. ¿It stays in your system.¿
Also in Phase I trials is AC3056, to prevent restenosis after vascular repair procedures and to treat diseases resulting from atherosclerosis. The compound was in-licensed from Aventis Pharma AG, of Frankfurt, Germany.
For the immediate future, though, all eyes are on Symlin again. The FDA¿s Endocrinologic and Metabolic Drugs Advisory Committee will take a look at it on July 26.
After the problems with the drug, Shearin said, ¿our management team had to take a step back and look at the data we had. They took it to a lot of outside experts ¿ people who always believed in Symlin, and people who had always been skeptics. They told us we just didn¿t design the studies very well, and that was a deciding factor in what kept us going. Then, we just executed what we needed to do.¿
The FDA accepted the NDA for Symlin for filing in January. A regulatory submission process is under way in Europe, with a filing expected in the second quarter of this year.
Amylin¿s stock closed Monday at $10.28, up 28 cents.