West Coast Editor
It's one down, one to go for Amylin Pharmaceuticals Inc., which won a hard-fought approval by the FDA of injectable Symlin (pramlintide acetate) for patients with Type I or Type II diabetes, whose insulin is not giving them glucose control.
Still awaiting action by the agency is exenatide for glucose control in Type II diabetics.
Amylin's stock (NASDAQ:AMLN) closed at $20.76, up $1.23.
"This was in line with what was expected," said Orville Kolterman, senior vice president of clinical affairs for San Diego-based Amylin. The product will be available in the next 90 days or so, and pricing has not been disclosed.
Symlin's road has been long. In 2003, the FDA issued its second approvable letter, asking for more data. Two years earlier, despite rejection by the Endocrinologic and Metabolic Drugs advisory panel, the agency in October 2001 issued an approvable letter for the compound if the company would conduct another clinical trial. (See BioWorld Today, July 27, 2001; Oct. 15, 2001; and Dec. 19, 2003.)
Amylin noted that Symlin is not intended for all patients with diabetes since, used with insulin, it has been associated with an increased risk of severe hypoglycemia, particularly in patients with Type I diabetes, typically within three hours after injection.
Exenatide is being developed in partnership with Indianapolis-based Eli Lilly and Co. to improve glucose control in Type II diabetics not hitting target glucose levels with metformin and/or sulfonylureas. A new drug application for a twice-daily formulation was submitted last summer, and the FDA is expected to act on the filing by April 30.
Although the two drugs "share some mechanism of action, there's significant difference," Kolterman said, noting that exenatide "stimulates insulin secretion when glucose is high and not when it is low," which makes that compound ideal for Type II diabetes patients.
Exenatide is the largest market opportunity, he said. About 18 million people in the U.S. have diabetes - 1 million with Type I and the remainder with Type II.
"About a third of the Type II patients are treated with insulin," he said. Exenatide initially was isolated from salivary secretions for the Gila monster.
Earlier this year, Amylin pulled down $176 million in a public offering that the company said would go toward expanding commercialization capabilities ahead of regulatory action on its Symlin and exenatide. (See BioWorld Today, Jan. 24, 2004.)