Centocor Inc. took less than six weeks to finalize an agreement on anew distributor for ReoPro in Japan.
Centocor said Monday it will receive $15 million up front andanother $12 million in milestone payments for granting FujisawaPharmaceutical Co. Ltd., of Tokyo, rights to distribute the anti-bloodclotting agent in Japan. Eli Lilly and Co., of Indianapolis, which hadworldwide ReoPro rights, gave up rights in Japan last month inexchange for about 920,716 Centocor shares.
Centocor shares (NASDAQ:CNTO) gained 44 cents Monday to closeat $32.13 after reaching $32 earlier in the day. At $32.13 Lilly's newshares are valued at about $29.5 million, meaning the deal comes outabout even financially. But Centocor should gain over the long termbecause of Fujisawa's advantages in the Japanese market and theincreased speed in which development is expected.
The monoclonal antibody is designed to inhibit platelet aggregation.It was approved in the U.S. in December 1994 for use in high-riskangioplasty patients. Sales are beginning to take off after a slow firstyear, and could increase significantly going forward because of newdata showing ReoPro's benefit in additional indications.
David Crossen, an analyst at Montgomery Securities in SanFrancisco, said the deal with Fujisawa is a good one for Centocor,even though ReoPro won't be on the market in Japan until 2000. Thedrug already is on the market in the U.S. and Europe.
"Fujisawa will move the process forward [in Japan] while Lillywasn't," Crossen said. "That's the most important issue. Fujisawawill be infinitely more successful at selling the product [in Japan]than Lilly ever could have been."
Centocor will get 50 percent of end sales in Japan from Fujisawa, likeit gets from Lilly, said Centocor spokesman Bruce Carroll. Fujisawaalso will cover all development costs. Centocor, of Malvern, Pa., saidPhase II studies of ReoPro in Japan will begin later this year.
Crossen estimated ReoPro sales will reach $145 million this year,more than most had predicted at the beginning of the year followinglackluster 1995 sales of $23 million. In five years sales will be $1.2billion, Crossen predicted, assuming wide use in angioplasty, use inhalf of stent procedures, some use in unstable angina patients and,later, use in acute syndromes. The model includes no revenues fromstroke, where Crossen said he believes there is potential.
Mike King, an analyst at Vector Securities International Inc. inDeerfield, Ill., also is optimistic about the prospects of ReoPro andliked the new deal with Fujisawa, which has a much better presencein the Japanese cardiology market than Lilly.
"I'm pleased it happened so quickly," alleviating any concerns theremay have been after Lilly gave up rights there last month, King said."They said they would have another agreement shortly and they did."
King is estimating 1996 ReoPro sales at about $152 million and 1997sales at $300 million.
Driving increased sales were results from two Phase III trials, calledCAPTURE and EPILOG, that in December 1995 were stopped earlybecause interim data was so strong. The EPILOG study was stoppedafter showing ReoPro could reduce death and heart attacks by morethan 70 percent following angioplasty, even routine procedures. TheCAPTURE study showed ReoPro stabilized severely ill unstableangina patients 24 hours prior to angioplasty and reduced their ratesof death or heart attack by 50 percent.
Centocor said it plans to file with the FDA by the end of the year tobroaden ReoPro's label to include the CAPTURE and EPILOGfindings. The antibody, which targets the IIb/IIIa receptor on plateletsto inhibit aggregation, also is in a Phase II study for acute myocardialinfarctions.
King said fourth-quarter ReoPro sales could increase because ofupcoming scientific presentations. Data from the CAPTURE andEPILOG trials will be presented at the European Congress ofCardiology meeting in Birmingham, U.K., next week, as well as one-year follow-up data from a study called EPIC. King said those will beimportant presentations as far as disseminating data to cardiologists.Centocor also will be presenting at the American Heart Associationmeeting in November.
Centocor also has begun enrolling patients in a study called EPILOGStent, which will compare ReoPro and stent use in combination andseparately. Stents are collapsible devices inserted into an artery toreinforce the artery and hold it open. Carroll said enrollment recentlybegan in the three-arm trial and should be completed in mid-1997.
Stents, recently introduced into the market, accounted for $500million in 1995 sales and that figure is growing. Centocor isinterested in determining if ReoPro and stents have synergisticbenefits, Carroll said. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.