CYberken,
looks like we have some positive statements from cephs partner. i like it, if we can get approval of both drugs in the next two months could see some valuation.
gw
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) 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), 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. |
