SAN DIEGO -- Amylin Pharmaceuticals Inc. said Monday that itfiled a investigational new drug application (IND) to startclinical testing of Normylin as a preventative for diabetichypoglycemia, or insulin shock, caused by low blood sugarlevels.
Clinical trials of Normylin should start by October in the UnitedStates and Europe, according to Amylin. The IND comes aboutsix months ahead of a schedule announced by the companyduring an initial public offering (IPO) presentation last January.
Monday's announcement also pointed to a shift in thecompany's priorities for Normylin, which it initially planned todevelop as a rescue treatment for diabetics who were in severediabetic shock.
"While we still expect to explore the ability of Normylin toprovide an effective rescue therapy for severe hypoglycemia,"said Howard E. Greene, Amylin's chairman and chief executiveofficer, "we have altered our schedule to focus initially on thelarger market potential associated with preventing suchattacks."
Amylin also said Monday that it was notified that it will beissued U.S. Patent No. 5,124,314 covering the composition ofthe natural form of amylin, a protein that is produced in thepancreas. The patent includes claims to pharmaceuticalcompositions that include both amylin and insulin, anotherpancreatic protein.
The protein amylin helps regulate blood sugar metabolism andprevents excessive insulin levels. In insulin-dependentdiabetics, excessive insulin can result in dangerously low bloodsugar levels. Recent studies have shown that people with type1, or juvenile-onset, diabetes, are deficient in both insulin andamylin.
The company has filed U.S. patent applications on Normylin,also called AC137, an analog of natural amylin. AC137 shouldhave some pharmaceutical benefits over natural amylin andwill be easier to manufacture, according to the company.
Amylin last December filed an IND for a safety and tolerabilitytrial of its natural amylin compound, called AC001. The AC001trials are to produce baseline data for comparison withNormylin and are not expected to be taken beyond Phase I,Marjorie H. Tillman, Amylin's vice president and chief financialofficer, said Monday. The company aims to evaluate theeffectiveness of Normylin in reducing the frequency andseverity of diabetic hypoglycemia in type 1 diabetics whocontinue on insulin injections.
The company's stock (NASDAQ:AMLN) closed Monday at $7.25,down 25 cents for the day. The company went public at $14 ashare last January.
At that time, Amylin said that Normylin could receivemarketing approval by 1997. Tillman on Monday suggested nospeed-up in that timetable, but noted the FDA's plans foraccelerated drug review in cases of life-threatening medicalconditions, among them diabetes. "It certainly indicates areceptive environment at the FDA," she said.
Amylin in 1987 obtained an exclusive license to pancreaticcells that produce insulin and a second hormone, amylin, fromBritain's Oxford University. Insulin regulates the uptake ofglycogen; amylin
"We do have plans, down the road, to combine insulin with theanalog or natural amylin," Tillman said.
In addition to working alone on amylin products to treat andprevent diabetic shock, Amylin is collaborating with Glaxo Inc.on an amylin blockade therapy. It is proposed as a treatment ofmetabolic disorders, including type 2 (adult-onset) diabetesand obesity, to which excess amylin is thought to contribute.
-- Ray Potter Senior Editor
(c) 1997 American Health Consultants. All rights reserved.