A month after signing a potential $100 million deal on itsdiabetes therapy with Johnson & Johnson, AmylinPharmaceuticals Inc. Monday launched the first of sixPhase III studies to prove its lead drug, in associationwith insulin, can improve control of blood glucose levelsin Type I and Type II diabetes patients.

Amylin Pharmaceuticals, of San Diego, said the sixstudies _ two one-year trials and four six-month trials _will involve about 2,000 diabetes patients, take more thantwo years to complete and will be used to supportsubmissions of new drug applications in the U.S. andEurope.

The drug, AC137, has been given the generic namepramlintide and is an analog of the human hormoneamylin. Like insulin, amylin, is secreted by the pancreasto control blood glucose levels and is deficient in diabetespatients.

In June, Johnson & Johnson, of New Brunswick, N.J.,agreed to a joint development and marketingcollaboration for AC137 that could pay Amylin as muchas $100 million. (See BioWorld Today, June 22, 1995, p.1.)

Marjorie Sennett, Amylin's chief financial officer, saidthe primary objective of the Phase III clinical trials willbe to demonstrate that AC137, administered in additionto insulin treatments, can reduce blood glucoseconcentrations following meals _ a time when diabetespatients experience a dangerous surge in glucose.

If AC137 lowers post-meal glucose levels, Sennett said,diabetes patients' overall average glucose concentrationwould be reduced, which in turn would lessen the long-term risks of diabetes-associated complications, such asdamage to eyes, kidneys and nerves.

In earlier clinical studies, AC137 showed it could lowerpost-meal glucose levels in both Type I and Type IIpatients. However, Amylin last year experienced anegative reaction on Wall Street when trial data alsoshowed AC137 did not alter hypoglycemia (dangerousreductions in glucose) induced by insulin overdose.

Sennett said Amylin initially considered that based onpreclinical trials AC137 might be able to offset theprecipitous drops in glucose levels experienced by somediabetics.

The Phase III studies, she said, are aimed at loweringpost-meal glucose levels while not increasing theincidence of hypoglycemia. If AC137 reduceshypoglycemia, she added, "that would be icing on thecake."

The first year-long Phase III study targets Type II diabetespatients. Later this year, a second Phase III trial, whichalso will take one year to complete, will begin in Type Idiabetics. In addition, six-month studies in both types ofdiabetes will be conducted in 1996 and 1997. Diabetespatients participating in the trial will continue theirregular insulin injections and receive doses of AC137before each meal.

The National Institutes of Health estimates in the U.S.there are about 700,000 people with Type I diabetes andas many as 13 million with Type II.

Amylin Pharmaceuticals stock (NASDAQ:AMLN)closed Monday unchanged at $7.38. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.