By Charles Craig
Chiron Corp. and partner Johnson & Johnson submitted applications for marketing approval with the FDA for their wound healing drug, Regranex, to treat diabetic skin ulcers.
The product is a gel form of platelet-derived growth factor beta (PGDF-B). Chiron, of Emeryville, Calif., makes the recombinant PGDF-B and supplies it to Johnson & Johnson, of New Brunswick, N.J., for manufacture in gel form.
In September 1995, Chiron and Johnson & Johnson said preliminary results from Phase III studies of Regranex were favorable, but they provided no details. (See BioWorld Today, Sept. 19, 1995, p. 4.)
Larry Kurtz, Chiron's vice president of corporate communications, said Thursday no additional information was available on findings from Johnson & Johnson's trials.
Both companies filed Biologics Licensing Applications for approval of Regranex.
Chiron and Johnson & Johnson have been working on development of wound healing products since 1986. Their first drug candidate, epidermal growth factor, did not show beneficial activity in clinical trials.
Diabetic skin ulcers are chronic wounds affecting hundreds of thousands of diabetes patients, putting them at risk of serious infections. In the U.S. infected diabetic foot ulcers cause an estimated 55,000 limb amputations each year.
Johnson & Johnson and Chiron also collaborate in two other areas, diagnostics and combinatorial chemistry.
Chiron's stock (NASDAQ:CHIR) closed Thursday at $19, up $0.375. Johnson & Johnson (NYSE:JNJ) ended the day at $49.75 unchanged. *