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Tuesday December 2, 6:25 pm Eastern Time
Chiron hopes for early '98 ALS drug OK
NEW YORK, Dec 2 (Reuters) - Chiron Corp Chief Executive Officer Edward Penhoet said on Tuesday that his
company and co-marketer Cephalon Inc (Nasdaq:CEPH - news) are more optimistic that their drug Myotrophin
for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, will be approved by the U.S. Food and
Drug Administration (FDA) in early 1998.
''We think the possibility of getting approval early next year is substantially enhanced over what it
was a few months ago,'' said Penhoet, speaking to investors at the BancAmerica Robertson Stephens
Medical Conference. ''We've made really good progress with the FDA in the last few months,'' he said.
In early November, Chiron and Cephalon withdrew their application for approval and resubmitted it, thus
buying up to six months more for FDA review. An FDA advisory panel rejected approval of the drug in May.
The companies were urged to conduct another major trial, but initially, they refused.
Penhoet said he is optimistic for approval for two reasons.
New analysis of the data further supports Myotrophin's utility, he said. And, said Penhoet, now the FDA
modernization act urges the agency to accept one major trial as proof of a drug's efficacy and safety.
The market for Myotrophin is likely to be ''several hundred million dollars'' annually, Penhoet said.
In the near future, Chiron also expects FDA approval of Regreanex (PDGF), a wound healing drug for
diabetics to be co-marketed with Johnson & Johnson (NYSE:JNJ - news), which should address a $150-to-200
million market.
Proleukin, already used for kidney cancer, should be approved for malignant melanoma, said Penhoet,
adding that he expects sales of $100 million for that drug in 1998.
DepoCyt, a drug for neoplastic meningitis that was co-developed with DepoTech, will be reviewed by an
FDA advisory panel in mid-December and should also be approved, he said.
More Quotes
and News:
Cephalon Inc (Nasdaq:CEPH - news)
Chiron Corp (Nasdaq:CHIR - news)
Johnson & Johnson Inc (NYSE:JNJ - news)
Related News Categories: biotech, health, medical/pharmaceutical
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