Centocor Inc. on Thursday said it is hiring a U.S. sales force forCentoxin and will be ready to launch sales as soon as the drugreceives final Food and Drug Administration approval.
Meanwhile, debate continued over the advantage Centocor mayhave gained over rival Xoma Corp., whose bid for approval forE5 to treat gram-negative sepsis was postponed by the FDA onWednesday.
Analysts focused on the fact that the FDA advisory committee,which Wednesday recommended approval for use of Centoxinagainst gram-negative bacteremia, didn't make arecommendation on labelling. The final label could define thesize of the market for Centoxin in the United States, wherethere are about 500,000 cases of sepsis annually.
"The FDA's query to the panel was safety and efficacy in apresumptive diagnosis of gram-negative bacteremia," saidDavid Stone, an analyst at Cowen & Co. A label of that nature"would end up being the same as a presumptive diagnosis ofgram-negative sepsis," Stone said. "It amounts to the broadestpossible label."
Centoxin's European label is for patients with sepsis syndromeand a presumptive diagnosis of gram-negative bacteremia.
"We think this approval is very strong for Centocor," saidJeffrey Swarz of Goldman Sachs. "We don't believe there willbe any restrictions on the label."
David Webber of Alex. Brown & Sons, who has been a Xomasupporter, interpreted the committee's action as a vote "infavor of the efficacy of Centoxin, with lots of reservations."He predicted that Centoxin will probably be approved withrestrictive labelling.
As far as Xoma's prospects, several analysts said E5's futureas a product is in doubt. "We don't believe E5 will ever getapproval by the FDA," said Swarz. "It's a dead product."
"While it's possible E5 could get on the market, I don't think itwill be approved unless (Xoma) can show it has a mortalitybenefit," said Jacqueline Siegel of Hambrecht & Quist.
Other analysts disagreed. "I assume Xoma will get approval bythe first quarter of next year or sooner," said Stone.
"I see no reason to believe E5 won't be approved," Webber said."The FDA took unusual pains to clarify any misperceptionsregarding the meaning of this delay."
FDA officials said the company was unable to produce clinicaldata in time for agency analysis before the meeting, but saidthat they did not anticipate difficulty finishing the job "in acouple of weeks."
"If Xoma gets a label for mortality reduction in patients withgram-negative sepsis, for patients with organ failure, thatcould be as good a label as Centocor's," said Stone. Data from asecond Phase III trial indicate E5 helped patients with gram-negative sepsis who had not entered shock, and in reversingthe occurrence of related organ failures.
Centocor, which hopes Centoxin might get final marketingapproval before year's end, saw its stock (NASDAQ:CNTO) climbanother $5 on Thursday, closing at $45.50. Stock of Berkeley,Calif.-based Xoma closed at $16, up 50 cents.
-- Karen Bernstein BioWorld Staff
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