Centocor Inc. on Thursday announced that its Centoxintreatment for gram-negative sepsis has been approved formarketing in the European Community.
Following the action by the ECLs Committee for ProprietaryMedicinal Products (CPMP), Centocor is filing for individualapprovals from EC member countries. The Malvern, Pa.,company expects approval in the Netherlands by June, followedshortly by Germany, said spokesman Richard Koenig.
Centocor's major rival, Xoma Corp. of Berkeley, Calif., stillawaits CPMP approval for its monoclonal sepsis treatment, E5.Xoma filed its CPMP application a few months after Centocor,which filed in early 1990, said Xoma spokeswoman CarolDeGuzman. Both companies have filed new drug applications togain U.S. marketing approval.
Gram-negative sepsis can lead to septic shock, which is markedby heart, liver and respiratory failure, and severe internalbleeding. The bacteria responsible for the condition areharmlessly present in the gut. But when spilled into the bodyby surgery or injury, they are extremely toxic. Up to three outof four patients die with conventional treatment.
According to the Centers for Disease Control in Atlanta, sepsiscases in the United States tripled in the past decade, reachingabout 500,000 in 1989. The increase is thought to be due to thewider use of aggressive therapies, such as surgery andimmunosuppressant drugs, and the aging of the population.
Centocor expects a similar number of cases in Europe. Two-thirds will be caused by gram-negative bacteria and will besuitable for treatment with Centoxin, said Koenig.
Centocor (NASDAQ:CNTO) closed up $1.75 at $66.50 onThursday. Xoma (NASDAQ:XOMA) closed at $26.88, down $2.13."The two stocks are acting the way you would expect," saidanalyst Peter Drake of Vector Securities International ofDeerfield, Ill.
Although Drake expects Centocor to capture the larger share ofboth European and U.S. markets, he recommends both stocks."The septic shock market is bigger than The Street anticipates,Jhe said. IThese are revolutionary drugs that will be usedbroadly, and one doesn't have to choose one or the other."
-- Rachel Nowak BioWorld Staff
(c) 1997 American Health Consultants. All rights reserved.