FDA Clears REGRANEX — becaplermin — Gel 0.01% for Diabetic Foot Ulcers; Chiron to Supply Active Ingredient to Ortho-McNeil

Business Wire, Dec 17, 1997

EMERYVILLE, Calif.--(BW HealthWire)--Dec. 17, 1997--Chiron Corporation (NASDAQ:CHIR) today announced that the U.S. Food and Drug Administration (FDA) has granted Ortho-McNeil Pharmaceutical Inc., marketing clearance for REGRANEX(R) (becaplermin) Gel 0.01%, the first biologic proven to increase the incidence of complete healing in diabetic foot ulcers.

Chiron Corporation supplies becaplermin, the active ingredient in REGRANEX Gel, to Ortho-McNeil Pharmaceutical Inc., who will manufacture and market REGRANEX Gel.

When used as an adjunct to, and not a substitute for, good ulcer care practices, including initial sharp debridement (removal of dead tissue), pressure relief and infection control, REGRANEX Gel increases the incidence of complete healing of diabetic ulcers. REGRANEX Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.

"This is an important milestone for Chiron and, most importantly, for diabetic patients suffering from these debilitating ulcers," said Lewis T. (Rusty) Williams, M.D., Ph.D., president, Chiron Technologies. "REGRANEX Gel from Ortho-McNeil is the first treatment to utilize a genetically engineered growth factor to stimulate the normal wound healing process in diabetic foot ulcers. REGRANEX Gel will be available to physicians and patients early next year through J&J's extensive distribution network."

More than two million people with diabetes will develop foot ulcers during their lifetime. Foot ulcers often go undetected since other ailments associated with diabetes -- such as nerve damage and visual and circulatory problems -- make it difficult for patients to feel or see the ulcer as it develops. These open sores often don't heal and may lead to serious complications including severe infection and amputation.

The active ingredient in REGRANEX Gel is becaplermin, a genetically engineered platelet-derived growth factor developed by Chiron Corporation that mimics a protein that occurs naturally in the body. The growth factor stimulates the migration of cells to the ulcer site, encouraging the patient's body to grow new tissue that heals these open wounds. Becaplermin is produced by recombinant technology in yeast cells and is not derived from blood.

Chiron Corporation is a science-driven, market directed healthcare company that combines diagnostic, vaccine and therapeutic strategies for controlling disease. Chiron also has research programs underway in gene therapy and gene transfer, combinatorial chemistry, cardiovascular disease and critical care.

CONTACT: Chiron Corporation

Jim Knighton, 510/923-6055