By Debbie Strickland
Chiron Corp. and partner Ortho McNeil Pharmaceutical have won FDA marketing clearance for Regranex (becaplermin) Gel, whose active ingredient is recombinant human platelet derived growth factor (PDGF), for treatment of diabetic foot ulcers.
The gel is slated for a February launch; the companies would not give pricing information.
Regranex is Emeryville, Calif.-based Chiron's first approved recombinant product since 1993, when the FDA approved Betaseron for multiple sclerosis.
"We see Regranex as a very important product to Chiron," said Jim Knighton, vice president for investor relations. "It's the first genetically engineered, or recombinant, wound-healing agent, and it's meeting a tremendous unmet medical need."
As for Ortho McNeil, the product opens the doors to diabetic and wound-healing markets, according to spokeswoman Lorie Gawreluk. Ortho, a subsidiary of Johnson & Johnson, in New Brunswick, N.J., is based in Raritan, N.J.
A possible second Regranex indication is pressure sores, for which the drug currently is undergoing Phase III trials.
Chiron will receive royalties of 25 percent on Regranex sales, and will net about 15 percent after footing cost-of-goods expenses, according to analysts Eric Schmidt and Tim Wilson, of UBS Securities, in New York.
UBS pegs the product's sales potential in the approved indication at $240 million, which would net Chiron $36 million.
Regranex is unlikely, however, "to have a meaningful impact on the company's bottom line," the analysts wrote Wednesday. Chiron's 1996 sales topped $1 billion.
For Chiron, Regranex could mark the beginning of a turnaround, after a spate of late-stage product setbacks beginning a year ago, when the company's prophylactic genital herpes vaccine failed to prove efficacy in Phase III trials. (See BioWorld Today, Nov. 26, 1997, p. 1.)
The UBS analysts "anticipate positive news flow from Chiron in upcoming months." The company has U.S. marketing rights to DepoCyt, a neoplastic meningitis drug scheduled for an FDA advisory panel meeting today. A Friday panel meeting will consider adding metastatic melanoma as an indication for Chiron's already-approved Proleukin.
Chiron's (NASDAQ:CHIR) shares closed Wednesday at $18.562, unchanged. Johnson & Johnson (NYSE:JNJ) ended the day at $66.375, up $1.062.
Chiron and Johnson & Johnson have additional collaborations in the fields of diagnostics and drug discovery using combinatorial chemistry.
In July, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee recommended approval of Regranex after clinical trial data revealed that foot ulcers treated with the drug healed at a 43 percent to 50 percent rate, vs. 28 percent to 35 percent for placebo. (See BioWorld Today, July 15, 1997, p. 1.) *