By Debbie Strickland
The company tested the drug on nearly 11,000 patients in a Phase III trial, the largest study of its kind ever conducted. Now it's up to the FDA to decide the fate of Integrilin (eptifibatide), a potential blockbuster drug for unstable angina and non-Q-wave myocardial infarction.
Integrilin's developer, South San Francisco-based Cor Therapeutics Inc., submitted the trial results in an amendment to its new drug application.
Cor's shares closed Wednesday at $17, up $0.375.
Following the release of upbeat trial data, the company earlier this month registered for a public offering of 2.5 million shares expected to raise $38.5 million.
An FDA decision could come as early as the second quarter of 1998, and, if approved, the product could hit the market in the third quarter of 1998, Cor Therapeutics said.
The company last winter sought FDA approval of Integrilin on the basis of the IMPACT II angioplasty trial, but the agency's Cardiovascular Renal Drugs Advisory Committee advised that more trial data were needed. Agency officials agreed and sent Cor Therapeutics a non-approvable letter.
By achieving statistical significance in the new Phase III trial's efficacy endpoints, including the primary one — prevention of death or myocardial infarction within 30 days following treatment — the drug's chances of winning approval in the U.S. and elsewhere are "extremely high," according to a report issued by analyst Matt Geller, of Oppenheimer & Co. Inc., in New York.
An inhibitor of platelet aggregation, Integrilin is a synthetic peptide derived from the venom of Southeastern pygmy rattlesnakes. Integrilin specifically blocks the glycoprotein (GP) IIb-IIIa receptor, which mediates platelet aggregation by binding fibrinogen.
Schering-Plough Corp., of Madison, N.J., has worldwide marketing rights to the product, which, if approved, will compete for market share with FDA-approved ReoPro, developed by Malvern, Pa.-based Centocor Inc. and marketed by Eli Lilly & Co., of Indianapolis. ReoPro, a monoclonal antibody, also targets the GP IIb/IIIa receptor. *