Both Centocor's Centoxin and Xoma's E5 are monoclonalantibodies to endotoxin for the treatment of the gram-negativeform of sepsis. Some estimates put the U.S. market for thesetherapies in excess of $750 million annually.
Gram-negative sepsis can lead to septic shock, which ismarked by heart, liver and respiratory failure, and severeinternal bleeding, resulting in death about half the time.
But not all cases are caused by gram-negative bacteria.Synergen Inc. (NASDAQ:SYGN), which is developing a competingproduct, estimates that of U.S. patients who enter shock, orabout 200,000 annually, 40 percent to 60 percent have sepsiscaused by gram-positive bacteria or fungi.
While neither Centocor nor Xoma's product has shown overallreductions in mortality in Phase III trials, Centoxin reducedthe mortality rate to 33 percent in patients with septic shock,compared with 57 percent in the placebo group.
Xoma's E5 didn't help patients already in shock. But for thesubgroup of patients who received the drug before they haddeveloped shock, survival rates increased by a factor of 2.3.Instances of organ failure also were significantly reduced.
Market and Patent Positions
Centoxin has marketing approval in the Netherlands, the UnitedKingdom and Germany. It also has a broad European patent, butno issued U.S. patent.
Xoma hasn't received a European patent or marketing approval.But it does have a U.S. patent and has sued Centocor for patentinfringement. The trial of Xoma's claims -- and Centocor'scountersuit -- began in July. Xoma rested its case last week,and Centocor has begun presenting its case.
Cetus Corp. (NASDAQ:CTUS) has a septic shock antibody inPhase III trials.
Other products in development will treat both gram-negativeand gram-positive bacteria. Synergen is completing Phase IItrials of Antril interleukin-1 receptor antagonist againstsepsis and septic shock.
Univax Biologics Inc. is conducting Phase I trials aimed atdeveloping a hyperimmune intravenous immunoglobulincontaining lipid A antibodies and E. coli antibodies for gram-negative coverage and staphylococcus antibodies for gram-positive coverage.
Nova Pharmaceutical Corp. (NASDAQ:NOVX) plans to file tobegin Phase I trials of its anti-inflammatory leumedincompound, NPC 15669, in early 1992. -- KB
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