ICN Stock Tumbles on FDA Rejection

ICN Pharmaceuticals Inc. common stock plunged in heavy trading Wednesday on news that federal officials had rejected an application by the Costa Mesa company for compassionate use of its drug Virazole among some patients infected with the AIDS virus.

The fourth-most-active issue on the New York Stock Exchange, ICN stock fell $3.625 to close at $11.125 a share on volume of 2.8 million shares. Wednesday’s close is only 87.5 cents above ICN’s low for the last year and is far off its 12-month high of $34 a share.

In a letter dated April 13, the Food and Drug Administration informed ICN that its investigational new drug (IND) request has been put on “clinical hold” because of a lack of evidence to justify the limited use that ICN sought.

Granting the IND request would have permitted the use of Virazole among some patients who harbor the AIDS virus but show few symptoms without the drug first winning formal FDA approval.

“What it means is that the evidence they submitted was not sufficient, in our opinion, to justify a treatment IND,” FDA spokesman Brad Stone said. “And, that’s as specific as we can get.”

Company officials said in a prepared statement that they “continue to have confidence” in Virazole--known generically as ribavirin--and that they are submitting information to the FDA “on a continuing basis.”

Common shares of ICN’s NASDAQ-listed Viratek Inc. subsidiary also were hammered Wednesday, falling $8 to close at $15 a share. Wednesday’s drop represented a 34.8% decline in the price of Viratek stock, which traded as high as $98 a share during the last year.

Also hit hard was SPI Pharmaceuticals Inc., ICN’s marketing subsidiary. SPI fell 30% in NASDAQ trading to close at $15 a share, down $6.50 for the day. The stock’s high for the last year has been $43.50 a share.