to all,
hope this spurs some interest (although both companies are on record as to approval).
gw
SAN FRANCISCO, Jan 15 (Reuters) - After a critical setback
last year, Cephalon Inc said Thursday that it remains
optimistic it will win U.S. and European approvals of its
Myotrophin drug in 1998.
"I certainly had many fewer gray hairs when we began the
approval process, but we continue to believe there's reason to
be optimistic," President Frank Baldino said at the Hambrecht
and Quist Healthcare Conference here.
"Lou Gehrig's disease is a fatal disease, and Myotrophin
slows the disease progression and lessens its severity." he
said.
Despite those claims, and the positive testimonials of many
patients with Lou Gehrig's Disease, Cephalon has had trouble
getting the Food and Drug Administration to approve Myotrophin.
An FDA Advisory panel last year recommended rejecting the
drug, after one clinical trial failed to show clear efficacy.
Since then, Cephalon and Chiron Corp (NASDAQ:CHIR), which jointly
developed the drug, have been working with the FDA to provide
more supportive data.
Although Myotrophin is not a cure for Lou Gehrig's Disease,
the companies maintain that it provides significant
quality-of-life improvements.
Lou Gehrig's Disease afflicts between 15,000 and 30,000
Americans, causing painful and crippling loss of muscle
function, and eventually leading to death.
Beyond Myotrophin, Cephalon said it is hoping to build its
drug portfolio with new treatments for sleep disorders.
Baldino told investors Cephalon also hopes this year to win
U.S. approval of a second drug, Provigil, to treat narcolepsy.
"Progivil is chemically different from the amphetamine-like
drugs currently used to treat sleepiness, and may be more
successful in treating subtle sleep disorders, such as
excessive daytime sleepiness," Baldino said.
"Most of us get sleepy during the day, but excessive
daytime sleepiness is a disorder and a significant unmet need,"
he said.
213-622-0056))
Copyright 1998, Reuters News Service |
