FDA Panel Rejects Companies' New Drug To Treat Lou Gehrig's Disease
=================================================================== 

BETHESDA, Md. -(Dow Jones)- A Food and Drug Administration panel voted
6-3 to reject Chiron Corp. and Cephalon Inc.'s  new-drug application for
Myotrophin, a treatment for Lou Gehrig's disease.  

"We are as anxious as nearly everyone afflicted (by the disease) in the
audience," said Dr. David A. Drachman, professor of neurology at the
University of Massachusetts Medical School. "My sense is we have seen
cosmetic changes in the data, nothing substantial. We find ourselves
where we were last June - we want more data."  

Members of the FDA's Peripheral and Central Nervous System Drug Advisory
Committee unanimously said the application had only one adequate and
well-controlled clinical trial proving efficacy of the drug.  

"The data does not look robust," said panel chairman Dr. Sid Gilman, of
the University of Michigan Medical Center.  

Meanwhile, Cephalon officials told the panel that more than $130 million
had been spent studying amyotrophic lateral sclerosis, the debilitating
and eventually fatal neuromuscular disorder that killed Yankees baseball
star Gehrig in 1941.  

Cephalon said the company remained committed to doing additional
studies, providing they gain approval.  

"There's no happiness in a decision like this," said analyst Ira Loss of
HSBC Washington Analysis. He added that he does not believe the drug is
finished. The agency is not bound by the panel's decision, but generally
follows its lead.  

Last June, the panel approved expanding access to Myotrophin under a
special application that allowed the drug to be given away for free
while its merits are debated.  

The two biotechs conducted two studies on the drug, one in the U.S. and
a second one in Europe. Last year, two analysts questioned the European
trial, saying it didn't confirm the U.S. results.  

An estimated 30,000 Americans suffer from ALS, a disease in which
patients slowly lose muscular function. Death often comes within five
years of diagnosis. The average age of onset of the disease is mid-50s.
The only approved drug for ALS is Rhone-Poulenc Rorer's Rilutek. Another
attempt to develop an ALS drug, one made by Regeneron Pharmaceuticals
Inc., failed earlier this year.  

Copyright (c) 1997 Dow Jones & Company, Inc.  

All Rights Reserved.