By Debbie Strickland

Chiron Corp.'s topical treatment for diabetic foot ulcers, Regranex, won an 11-4 favorable vote from the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee Monday and will likely be reviewed by the agency for final approval by the end of the year.

"This is incredibly important to us, not only financially, but also because it reinforces some of the other collaborations we have going," said Jim Knighton, vice president for investor relations at the Emeryville, Calif., company.

The vote came after the markets closed. Chiron's shares (NASDAQ:CHIR) ended the day at $20.625, down $0.563.

Regranex (becaplermin) -- to be marketed by Chiron's longtime collaborative partner Johnson & Johnson, of New Brunswick, N.J.-- is a gel form of recombinant human platelet-derived growth factor beta (PGDF-BB). Chiron will receive gross royalties of approximately 25 percent and will manufacture the drug's active ingredient.

The advisory panel hearing marked the first release of details from Regranex's late-stage clinical trials, conducted by Johnson & Johnson.

The companies disclosed that foot ulcers treated with the drug healed at a 43 to 50 percent rate, vs. 28 to 35 percent for placebo. The results were statistically significant, according to Knighton, and the drug's safety data were stellar, resulting in the advisory panel's separate unanimous vote of confidence in Regranex's safety.

For Chiron, the panel's nod provided a much-needed shot of good news.

"Chiron's had a very difficult year, and had a difficult second half last year," said analyst Eric Schmidt, of UBS Securities L.L.C., in New York.

In the last two months, the company's collaborative amyotrophic lateral sclerosis drug failed to win an FDA advisory panel recommendation, and a Chiron monoclonal antibody licensed to Bayer AG, of Leverkusen, Germany, failed to beat placebo in a Phase III trial. (See BioWorld Today, May 9, 1997, p. 1, and May 22, 1997, p. 1.)

Last fall, the company's prophylactic genital herpes vaccine failed to prove efficacy in Phase III trials. (See BioWorld Today, Nov. 26, 1997, p. 1.)

"We've had some disappointments lately," said Knighton, "but that's the nature of this business."

Analysts have pegged Regranex's revenue potential at anywhere from $100 million to $300 million by 2000. At sales of $250 million, Chiron would gross about $63 million in annual royalties. The company's revenues in 1996 topped $1 billion.

Chiron and Johnson & Johnson filed biologics licensing applications for Regranex in December 1996.

The companies began their collaboration to develop wound-healing products in 1986. Their first drug candidate, epidermal growth factor, did not show beneficial activity in clinical trials.

The companies also are collaborating on diagnostics and drug discovery using combinatorial chemistry. *