Centocor Inc.'s stock soared Friday 68 percent followingrelease of positive results from a large scale studyindicating the company's anti-blood clotting drugReoPro, which has experienced slower than expectedfirst-year sales, could be more widely used withangioplasty.

ReoPro, a monoclonal antibody that inhibits plateletaggregation, was approved a year ago by the FDA andEuropean authorities for prevention of blood clotsfollowing angioplasty in patients who are at high risk ofartery reclosure.

High risk patients account for about 10 percent to 30percent of the more than 700,000 balloon angioplastyprocedures performed each year in the U.S. and Europe.

On Thursday a 4,800-patient trial to evaluate ReoPro foruse with all angioplasties was stopped after data from thefirst 1,500 participants demonstrated the drugsuccessfully achieved the study's primary endpoints ofpreventing death and heart attacks within 30 days of theprocedures.

The data, clinical investigators said, showed ReoProreduced by about 70 percent the rate of death and heartattacks even in routine, elective angioplasties. Theinterim results in the placebo-controlled trial alsorevealed bleeding, considered a troublesome side effect ofReoPro, was no more of a concern in the treatmentgroups than the placebo group.

Timothy Cost, senior vice president of strategicoperations at Centocor, said Friday the Malvern, Pa.-based company will release details of the placebo-controlled study, called EPILOG, in 1996 during ascientific conference.

He added Centocor also will meet with the FDA next yearto discuss filing a product license application to expandReoPro's label to all patients receiving angioplasty.

Centocor's stock (NASDAQ:CNTO) surged $9.75 toclose at $24 Friday.

ReoPro is marketed by Centocor's partner, Eli Lilly andCo., of Indianapolis. Lilly's stock (NYSE:LLY) ended theday at $104.75 up $2.

Reijer Lenstra, analyst with Smith Barney Shearson inNew York, said he upgraded Centocor from neutral toout-perform based on the EPILOG trial's findings.

He said he expects the FDA will expand ReoPro's labeland the drug may be used more by physicians based onevidence bleeding is not a problem, particularly whenReoPro is used with low-dose heparin.

ReoPro's price, $1,350 per treatment, and concerns aboutbleeding were among reasons cited by analysts for thedrug's lower than expected 1995 sales. Projections hadranged as high as $100 million for the first year.

Lilly launched ReoPro on the market in February 1995and through Sept. 30, 1995, its sales totaled about $10million. Centocor's revenues from Lilly for shipments ofthe drug through the first nine months of this year were$14 million. The two companies' collaboration calls forthem to split profits equally.

Lenstra said Centocor's good news is bad news for CorTherapeutics Inc., of South San Francisco, which has arival platelet inhibitor, Integrelin, in late-stage clinicaldevelopment for angioplasty. He downgraded Cor frombuy to neutral Friday.

Lenstra had given Cor's product an edge over Centocor'sbecause Integrelin did not cause bleeding. However, inaddition to reducing concerns about bleeding, theEPILOG trial demonstrated ReoPro apparently has betterefficacy than Integrelin.

Results of a Phase III study of Integrelin in June 1995showed a 22 percent reduction in adverse cardiac eventsfollowing angioplasty compared with ReoPro's 70percent reduction in the EPILOG study's interimfindings.

Cor's stock (NASDAQ:CORR) closed Friday down$2.62 to $9, a 22.5 percent drop.

Cost said more than 2,500 patients were enrolled in thetrial before it was halted and data analysis will continuefor all the participants. In addition to assessing ReoPro'sability to prevent complications 30 days after angioplasty,the EPILOG study also is designed to follow patients forsix months to see how ReoPro performs in reducingdeath, heart attacks and the need for repeat angioplasties.

EPILOG stands for Evaluation in PTCA (percutaneoustransluminal catheter angioplasty) to Improve Long-termOutcome with ReoPro GP IIb/IIIa Blockade. The drugtargets the IIb/IIIa receptor to inhibit platelet aggregation.

In halting the EPILOG trial the Safety and EfficacyMonitoring Committee (SEMC) analyzing the interimresults said the data revealed dramatic evidence ofefficacy and demonstrated major bleeding events were thesame in the placebo and treatment groups.

The trial divided patients into three groups; thosereceiving a placebo and the rest who were given ReoProwith either low-dose or standard-dose heparin. Thepatients getting a placebo also received heparin.

Cost said the SEMC's finding that major bleeding eventswere the same in the placebo and treatment groupssupports Centocor's contention and previous findings thatheparin is the major culprit. Prior to the EPILOG trial, astudy showed dosages of heparin, the standardanticoagulant used in coronary procedures, can bereduced with ReoPro and when lower heparin doses areused bleeding is less of a problem.

Cost also said Centocor is conducting a cost-benefitanalysis of ReoPro's use to counter concerns about thedrug's price. n

-- Charles Craig

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