Centocor Inc. said it has terminated all but one trial for its anti-infective, HA-1A.
The Malvern, Pa., company (NASDAQ:CNTO) had suspended itssecond Phase III trial on Jan. 18 due to excessive deaths, andannounced it would decide whether to continue after analyzingthe data.
The company's monoclonal antibody to the endotoxin thatcauses an immune overreaction in patients whose blood isinfected with Gram-negative bacteria, HA-1A, was intended tohelp some 200,000 Americans who develop Gram-negativesepsis each year.
However, the company concluded that in these patients "therewas no reduction in the mortality rate among HA-1A-treatedpatients in comparison with placebo-treated patients when thetrial terminated."
The company studied 2,471 patients in 552 centers.
The FDA told Centocor last April that another Phase III wasnecessary before HA-1A could receive marketing approval.
Centocor is continuing a trial in pediatric patients withfulminant meningococcemia, telling analysts in a conferencecall Tuesday that these patients have no underlying diseases(such as cancer, which can negatively affect mortality rates).
The company expects to design more studies to test thecompound in sicker patients. However, Eli Lilly and Co. lastyear acquired for $100 million a 5 percent stake in theCentocor and the rights to its second-leading drug,cardiovascular agent CentoRx, for no additional money if HA-1A does not receive marketing approval by the end of thisyear. If HA-1A was approved, Lilly would give Centocor anadditional $25 million for rights to CentoRx.
Centocor's financial outlook is "obviously going to be nip andtuck," said analyst Franklin Berger of Josephthal Lyon & Ross.The company has $50 million in diagnostic sales, $70 millioncommitted to its research and development arm, Tocor II, $150million in cash and a burn rate of about $25 million a quarterthat may be reduced further, Berger said.
Also, Centocor could seek to resume sales of HA-1A in Europe ifthe drug escapes fallout from the U.S. trial. European sales ofHA-1A in 1992 were between $15 million and $20 million.
Berger has issued a "sell" recommendation on the stock,although he likes HA-1A because the compound clearsendotoxin from the system, which may someday prove usefulin a "cocktail" approach to the complex syndrome.
The consensus appears to be that Phase II trials need to bedesigned differently in sepsis, he added. Bigger trials withnarrower entry requirements and more emphasis on subgroupscould indicate potential benefits of the compound. Also, patientprofiles that include cytokine and bacterial levels could helppredict outcome.
Analyst Jay Silverman of Wertheimer Schroeder & Co. said thatwith all the companies now in the running for a sepsistreatement, the time and money such trials entail weighsagainst Centocor. HA-1A "had two chances and it didn't makeit," he said. "They'll continue to pursue it because it's such a bigmarket."
Centocor spokesman Thomas Pearson declined to discuss HA-1A on Tuesday, saying the company was focusing on CentoRx.031793HA-1A
-- Nancy Garcia Associate Editor
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