Amylin Trials Spark $22 Million From J&J

Amylin Pharmaceuticals' diabetes treatment pramlintide has won through an interim analysis of two ongoing Phase III trials, stimulating a $22 million milestone payment from partner Johnson & Johnson. None of the clinical data will be disclosed prior to completion of the one-year studies so as not to compromise the blinding of the data.

Pramlintide is a human agonist of the hormone amylin, discovered in the 1980s. J&J's $22 million milestone, in the form of $7 million in option payments payable in the third quarter of 1996 and $15 million in equity to be acquired before the completion of the Phase III program, is in addition to $50 million in funding already invested in the venture. The option fee payment represents a nonrefundable prepayment of a portion of the license fee required for expansion of the field of the collaboration beyond pramlintide, to include other amylin agonists.

The two Phase III studies are aimed at determining the ability of pramlintide to improve glucose control in people with type I and type II diabetes who need to maintain themselves on insulin therapy. Specifically, the studies are looking at the levels of glycosylated hemoglobin in patients, which has become a widely-used measure of glucose control. The landmark Diabetes Control and Complications Trial (DCCT; Marketletter April 25, 1994), has proved that glycosylated hemoglobin serves as a valid marker for glucose control and that tight control leads to far fewer complications, including blindness, kidney failure etc, in later life.