COR Therapeutics, Inc. Announces Results of FDA'S Advisory Committee Meeting.SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif.--(BUSINESS WIRE)--Feb. 28, 1997-- COR Therapeutics, Inc. (Nasdaq: CORR CORR Used on the consolidated tape to indicate a correction in a reported transaction : CORR.LAST.GY 50 WAS 51. ) today announced that the U.S. Food and Drug Administration's (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Cardiovascular and Renal Drugs Advisory Committee decided that the IMPACT II trial of INTEGRILIN(TM) (antithrombotic injection) had shown positive results as an adjunct therapy in helping to prevent acute cardiac ischemic Ischemic An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery. Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation ischemic complications in patients undergoing percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty n. Abbr. PTCA A procedure for enlarging a narrowed arterial lumen by peripheral introduction of a balloon-tip catheter followed by dilation of the lumen as the inflated catheter tip is (PTCA PTCA abbr. percutaneous transluminal coronary angioplasty PTCA Percutaneous transluminal coronary angioplasty, see there ). However, because the Committee also 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, the Committee recommended against approval of the INTEGRILIN(TM) product at this time. In response, Vaughn M. Kailian, President and CEO of COR Therapeutics stated, "Obviously, we are gratified by the Committee's conclusion that the IMPACT II trial showed positive results. At the same time, we are clearly disappointed with the recommendation to not approve the drug at this time because we believe INTEGRILIN(TM) provides real benefit to patients and should be approved. We look forward to working with the FDA to determine the next steps." COR Therapeutics, Inc. is dedicated to the discovery, development and commercialization of novel pharmaceutical products for the treatment and prevention of severe cardiovascular diseases. COR has complementary product research and development programs that seek to address critical needs in severe cardiovascular care, including unstable angina, acute myocardial infarction acute myocardial infarction (  ·kyōōtˑ mī·ō·karˑ·dē· , deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. and restenosis. COR and Schering-Plough Corporation are worldwide partners for the INTEGRILIN(TM) product, which is also being studied for the treatment of unstable angina and acute myocardial infarction. This press release contains forward-looking statements that are subject to risks and uncertainties that may cause the Company's actual results to differ materially. A full discussion of the Company's operations and financial condition, and specific factors that could cause the Company's actual performance to differ from current expectations, are discussed in the Company's SEC reports, including but not limited to the Company's Form 10-Q for the quarter ended September 30, 1996 and Report on Form 10-K for the year ended December 31, 1995. CONTACT: COR Therapeutics, Inc. Burns McClellan, Inc. Laura A. Brege Lisa Burns (Investors) Jacquelyn A. Jeffries Justin Jackson (Media) (415) 244-6893 (212) 505-1919 |
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