Genta vows to press on with cancer drug
Thursday, May 06, 2004
BY SUSAN TODD
Star-Ledger Staff
Genta's top executive said late yesterday the company is not giving up on its lead drug despite a major blow that could require the biotech company to conduct additional tests before it can be approved to treat skin cancer.
But Raymond Warrell, Genta's chief executive, told Wall Street analysts he believed the company has submitted a complete application showing the drug was safe and effective in treating melanoma.
Earlier this week, an advisory panel to the Food and Drug Administration failed to recommend approval of the drug known as Genasense.
"The vote is a significant setback," Warrell said. "We are continuing to develop Genasense with the objective of gaining approval."
According to information released on the panel's vote, the experts did not believe the data clearly showed Genasense stopped the spread of the disease.
Shares of the company have fallen 71 percent since April 27. They gained 9 percent yesterday but fell in after-hours trading following the teleconference.
Warrell did not elaborate on the company's plans. The FDA is expected to release its decision on Genta's application next month.
In the conference call with analysts, Warrell read a brief statement but declined to answer questions as a result of a lawsuit. "This is a particularly sensitive time for the company," he said.
A Philadelphia law firm yesterday filed notice of a class-action securities fraud suit as a result of the advisory panel's decision.
One analyst, Reni Benjamin of Rodman and Renshaw, said other biotech companies have suffered similar setbacks and, eventually, have succeeded in securing the FDA's approval. Erbitux, he said, may be the most famous.
After its initial rejection, ImClone and its partner, Bristol- Myers, spent more than a year trying to recover from the blow and the ensuing controversies.
Erbitux was ultimately approved in February.
Benjamin said it could take Genta two years to redo part of the clinical trial criticized by the FDA's advisory committee. |
