FDA Panel Rejects Myotrophin Again

Cephalon and Chiron suffered a blow last week when they failed to get apositive approval recommendation for approval of Myotrophin (mecasermin), a candidate drug for the treatment of amyotrophic lateral sclerosis. On Friday May 9, the day of the announcement, Cephalon's share price dropped by 40% to $12, while Chiron, the marketing partner for the drug, saw its price fall 4% to $19.13.

The US Food and Drug Administration's Peripheral & Central Nervous System Drugs Advisory Committee voted six-to-three not to recommend approval, saying that Cephalon had been unable to present substantial evidence that Myotrophin was effective in ALS. "The data do not look robust; they look modest," commented panel chairman Sid Gilman of the University of Michigan Medical Center.

Another panelist noted that the company had only presented "cosmetic" changes to the dossier, and that the committee had hoped for better and more information than was presented at the last meeting in June 1996. At that time, no vote was taken on the drug.