Centocor Inc. shares rose $1 to $30.50 on Tuesday after FirstBoston analyst Jeffrey Swarz predicted that FDA marketingapproval of Centoxin is very near.
"We strongly believe all the FDA questions have been resolvedto the FDA's satisfaction and that the FDA focused on twoissues: absorption of Centoxin in the blood in an animal modeland enrollment of patients in the Phase III study from onemedical center," Swarz wrote. "We believe that both of theseissues have been resolved to the FDA's satisfaction and that,with the resolution, approval of Centoxin is very near."
But Jay Silverman of Nomura Research Institute said thataccording to his sources, "the problems Centocor has beenasked to respond to at the FDA are very serious and theyhaven't been responded to."
Silverman said the company has been asked to discuss changesin clinical trial protocols 15 months into the study. In addition,said Silverman, the FDA is asking about the imbalance inpatient populations and data from various centers and whythose weren't adjusted for statistically.
A Centocor spokesman declined to comment on the company'sdiscussions with the FDA.
Last September, an FDA advisory committee recommendedapproval of the monoclonal antibody to treat gram-negativebacteremia or septic shock. In February, the Malvern, Pa.,company (NASDAQ:CNTO) said that the FDA had requestedfurther information.
Swarz estimated Centoxin sales for the first 12 months will bemore than $350 million, with 1992 earnings per share of $1.48and 1993 earnings of $3.23.
Reflecting the wide split in the analyst community over theprobable impact of Centoxin, Silverman put 1992 sales at amaximum of $125 million, with a per-share loss for the year of$2.25. At their peak in 1993 and 1994, he estimated worldwidesales at $240 million to $250 million, with a 1993 per-shareloss of $1.25. -- Karen Bernstein
-- Karen Bernstein BioWorld Staff
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