By Jim Shrine
Special To BioWorld Today
Six-month follow-up data from Centocor Inc.'s anti-platelet drug ReoPro in combination with stent procedures were as impressive as initial results, showing a 51 percent reduction in death or heart attack when compared to stent alone.
The new data suggest the drug, which blocks the glycoprotein IIb/IIIa receptor, will gain increased usage in coronary intervention procedures. ReoPro initially was approved in December 1994 as a platelet inhibitor, and won expanded labeling in 1997 to allow marketing to prevent cardiac ischemic complications in a range of patients undergoing percutaneous coronary intervention. (See BioWorld Today, Nov. 7, 1997, p. 1.)
"There are a lot of reasons why ReoPro should continue to do well," said Jay Silverman, senior biotechnology analyst at BancBoston Robertson Stephens, in New York. "The stent data is just part of that. It's a large and growing class of drugs, and ReoPro is the leader."
Centocor, of Malvern, Pa., is estimating 1998 sales of ReoPro will total $320 million to $350 million, a little below the estimates of many analysts. Centocor records 50 to 55 percent of sales of the product, which is co-marketed in the U.S. by Eli Lilly and Co., of Indianapolis.
Results from the Epistent, or Epilog-Stent, trial were presented for the first time in the U.S. at a conference in Washington. The data also showed ReoPro and angioplasty provided 31 percent better benefit than stent alone.
The six-month results of the Epistent trial confirmed 30-day results, which were presented in March at the American College of Cardiology conference. The longer-term results were first disclosed at a cardiology conference in Vienna, Austria, in August.
The Epistent (which stands for "evaluation of IIb/IIIa platelet inhibitor for stenting") trial was the largest coronary stent trial ever conducted. It involved 2,399 ischemic heart disease patients randomized into three groups: stent plus placebo, stent plus ReoPro, or balloon angioplasty plus ReoPro. All patients received the blood thinners aspirin and heparin. The primary endpoint was a composite of death, heart attack or need for urgent vascularization at 30 days.
The composite within six months was reduced from 18.3 percent in the stent-only group to 13 percent in the ReoPro and stent group. Also, each component in composite was lower in the ReoPro-stent group.
Reduction in death or heart attack was more noticeable in patients presenting unstable angina within 48 hours of randomization. In that group, 14.5 percent of those receiving stent-placebo had a heart attack or died by six months as compared to 4.5 percent in the ReoPro-stent group — a 69 percent reduction.
In diabetics, whose outcomes generally are worse after coronary procedures, the composite endpoint was reduced by 48 percent in the stent-ReoPro group, while target vessel revascularization was reduced more than 50 percent.
ReoPro Could Hit Stent Level Of Penetration
These results make a convincing case for widespread ReoPro use with stents, said Silverman.
"ReoPro penetration is now less than 40 to 50 percent," he said. "This can get it to the stent penetration, which is 70 percent or higher."
Centocor spokesman Christopher Allman said ReoPro can provide cost savings, even at $1,350 per infusion.
"There is a cost-effectiveness story here that is often overlooked when you look at just the price of the product," Allman said. "Patients are out of the hospital sooner and stay well longer."
Centocor's ReoPro is one of three IIb/IIIa inhibitors on the market. The other two were given FDA approval in the spring. They are Whitehouse, N.J.-based Merck & Co. Inc.'s Aggrastat and South San Francisco-based COR Therapeutics Inc.'s Integrilin.
Next month, Centocor will present additional data from other trials at the American Heart Association meeting in Dallas. These studies are testing ReoPro in combination with thrombolytic agents.
In August, Centocor received marketing approval for its monoclonal antibody Remicade for treating Crohn's disease, and has its own approved clot buster, Retavase, which was purchased in February from Boehringer Mannheim GmbH, of Mannheim, Germany, for $335 million.
Centocor's stock (NASDAQ:CNTO) closed Friday at $38.187, up $2.312. *