By Frances Bishopp
While Cor Therapeutics Inc.'s stock fell about 30 percent on Friday's news that an FDA advisory committee had unanimously rejected its application to market Integrilin as an adjunctive therapy in balloon angioplasty, some analysts said the key indication for the drug is unstable angina, currently the focus of a Phase III clinical trial expected to conclude in July.
Cor's stock (NASDAQ:CORR) dropped $2.937 Monday to close at $9.375.
Cor's stock plummeted 45 percent on June 14, 1995, after the company released preliminary data from the Impact II study showing Integrilin did not reach statistical significance compared with placebo in its primary composite endpoint * preventing death, heart attack and reclosure of arteries following angioplasty.
"The implications [of the FDA decision] are actually not that substantial," Matthew Geller, an analyst with Oppenheimer & Co., of New York, told BioWorld Today. "The key indication is unstable angina, which is a potential billion-dollar indication."
"The big news is yet to come," Geller said. "It will be the make-it or break-it result for the company."
While concurring that the data presented indicated Integrilin had activity, the FDA committee decided that the results of the Impact II trial alone were not sufficiently compelling to forego the FDA's customary requirement of two positive clinical trials prior to the approval of a new drug.
Vaughn Kailian, president and CEO of Cor, of South San Francisco, said Monday the plan now is to have more talks with the FDA and Schering-Plough Corp., of Madison, N.J., Cor's partner for the product. "We are going back in to talk to the FDA as soon as we can get a meeting arranged," Kailian said, "to discuss exactly where we go next."
Integrilin, an inhibitor of platelet aggregation, is a synthetic peptide derived from the venom of southeastern pygmy rattlesnakes. Cor's lead product, it specifically blocks the Gpllb-llla receptor, which mediates platelet aggregation by binding fibrinogen.
The current Phase III Pursuit clinical trial for unstable angina and non Q-wave MI has enrolled a total of 10,948 patients in the U.S., Canada, Europe and Latin America at 725 sites, 280 of which are in the U.S.
This trial, Geller said, is at a much higher dose than the Impact II trial of Integrilin. "There is good reason to believe the product will be more potent at a higher dose," Geller said.
The Impact II trial, which enrolled 3,871 patients undergoing elective and urgent angioplasty, administered 135 micrograms/kilogram of Integrilin at the time of the procedure, followed by an infusion of 0.5 microgram/kilogram of Integrilin, aspirin and heparin.
The second group received the same initial dose of Integrilin, followed by an Integrilin infusion of 0.75 microgram/kilogram. The placebo group received only an infusion of aspirin and heparin.
The Phase III Pursuit trial administers 180 micrograms/kilogram of Integrilin, followed by an infusion of 2 micrograms/kilogram. The trial contains only two arms after the Data and Safety Monitoring Committee reviewed the dosing and decided to drop the lower dosing arm. *