The U.S. Department of Defense's preparations to care fortroops injured in the Persian Gulf war have served to intensifyan ongoing battle between Centocor Inc. of Malvern, Pa., andXoma Corp., of Berkeley, Calif.
Xoma is now arranging to supply the U.S. military in the Gulfwith its septic shock treatment, E5 (formerly Xomen-E5), Xomaspokeswoman Carol DeGuzman said last week. She declinedcomment on the cost or size of the E5 consignment.
Apparently a step ahead on the military effort, Centocor saidlast September that the Army ordered 200 doses of its rivaltreatment, Centoxin, for use in the Middle East at a cost of$2,500 per dose. The Army then said it had no plans to buy E5,leading investment analyst Robert Kupor of Kidder, Peabody &Co. to tell BioWorld, "I see the Army's order as confirmationthat Centoxin is clearly the superior drug."
E5 and Centoxin are used to treat infections that cause gram-negative sepsis, which can lead to septic shock. Septic shock ismarked by heart, liver, kidney and respiratory failure, andsevere internal bleeding. The gram-negative bacteriaresponsible for causing the conditions are harmlessly presentin the gut, unless they are spilled by injury or surgery into thebody, where they are extremely toxic.
E5 and Centoxin, both monoclonal antibody-based products, aredesigned to neutralize the poisonous endotoxins produced bythe bacteria. "Centoxin dramatically improves survival rate,"according to Centocor spokesman Charles Cabot.
Conventional treatment of septic shock relies on antibiotics andsupportive care, such as kidney dialysis and blood infusions.Still, three out of four patients in septic shock die.
Xoma and Centocor are also embroiled in a patent infringementbattle over their anti-endotoxin monoclonal antibodies, withthe next round of litigation starting in July in the U.S. DistrictCourt for Northern California. (For more information searchIndustry Library for 122190XOMA.)
Both companies have filed a new drug application to gainmarketing approval of their products.
Although there has been speculation that wartime success ofeither drug could buttress its chances of Food and DrugAdministration approval, analyst Denise Gilbert of CountyNatWest Securities disagrees. Data collected on war injuries arenot going to affect the FDA's decision to license because "if theclinical trials have been done properly, the same thing shouldhappen when the Army uses the drugs," she said.
U.S. Army spokeswoman Susan Hansen refused to comment onwhether exemption from acquiring "informed consent" fromtroops treated with E5 or Centoxin has been requested from theFDA. Interim regulations announced by the FDA last monthwould allow American troops in combat to be givenunapproved experimental drugs or vaccines without theirinformed consent.
Pentagon officials have said that exemptions have beenrequested only for three drugs. One has been approved foranother indication, one is routinely used by laboratory workersand a third has long been used as a cosmetic.
Public Citizen, a consumer watchdog group, has filed suit toblock the military's use of unapproved drugs without informedconsent. The court case is scheduled to start Friday in the U.S.district court for the District of Columbia.
-- Rachel Nowak BioWorld Staff
(c) 1997 American Health Consultants. All rights reserved.