By Lisa Seachrist
WASHINGTON — The FDA expanded the label of Centocor Inc.'s ReoPro — an inhibitor of platelet aggregation — to allow physicians to use the drug in a much broader group of patients.
The move allows the company to market the drug as an adjunctive therapy to prevent blood flow stoppages to the heart in patients undergoing percutaneous coronary intervention (PCI) — balloon angioplasty, atherectomy and stent placement — as well as in unstable angina patients who are not responding to medical therapy when PCI is planned within 24 hours.
Previously, ReoPro was indicated for use only in angioplasty patients at high risk for complications. In addition, the product was meant to be used only in the hour before the procedure and the 12 hours after the procedure. The new labeling allows ReoPro to be used 18 to 24 hours prior to any PCI.
"This is really a big step for this class of drugs, and it is pretty exciting," said Bruce Carroll, manager of government affairs and public relations at the Malvern, Pa., company. "We are able to go outside the [heart catheterization laboratory] to unstable angina patients."
Currently, 450,000 angioplasties are performed in the U.S. With the new label, drug sales could reach $325 million in 1998.
ReoPro is a monoclonal antibody that inhibits platelet aggregation and prevents formation of blood clots. It was originally approved in the U.S. in December 1994.
Centocor submitted a supplemental application to the FDA based on the results of two clinical trials. The EPILOG trial tested ReoPro in a broad population of angioplasty patients, regardless of risk, in combination with low dose heparin. In the 30 days following the procedure, the regimen reduced the number of deaths, myocardial infarction and urgent intervention by 56 percent compared to a placebo. There was a 43 percent reduction of adverse events six months following the procedure.
The CAPTURE trial tested ReoPro with unstable angina patients slated to undergo angioplasty within 24 hours. ReoPro reduced adverse events by 29 percent.
"One of the major things is that we have an indication for using ReoPro with stent placement," Carroll said. "We intend to aggressively market ReoPro for all of its indications."
New Label Boosts ReoPro Market Position
Analyst David Crossen, of NationsBanc Montgomery Securities, in San Francisco, agreed that the label offers the company an opportunity for sales growth.
"The label was really a good one," Crossen said. "We were expecting it to include angioplasties and unstable angina. Lumping angioplasties and stent placement together is a real big advantage."
In addition, the label may make it very difficult for South San Francisco-based COR Therapeutics Inc.'s Integrilin — a platelet aggregation inhibitor — to ever obtain a significant share of the market should it win FDA approval, Crossen told BioWorld Today.
"This label is pretty devastating to the competition," Crossen said. "And I think this is only the beginning for what we can expect for ReoPro."
Carroll noted that the company intends to test ReoPro in stroke victims and will announce preliminary results of a study of ReoPro and low-dose thrombolytics in patients suffering acute myocardial infarction at the American Heart Association Meeting beginning Nov. 8 in Orlando, Fla.
Eli Lilly and Co., of Indianapolis, has worldwide marketing rights to ReoPro except in Japan, where Fujisawa Pharmaceutical Co., of Osaka, has the rights.
In its second quarter 1997 fiscal report, Centocor said ReoPro sales to Lilly were $40.6 million and Lilly's sales to customers totaled $59.8 million.
Centocor's stock (NASDAQ: CNTO) closed at $52 per share, up $2.50. *