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INTEGRILIN Stent Study Halted Early Due to Positive Results.

Business Editors and Health/Medical Writers

SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Feb. 4, 2000

COR Therapeutics, Inc. (Nasdaq:CORR) and Schering-Plough Corporation (NYSE:SGP) announced today that enrollment in the ESPRIT study of INTEGRILIN (R) (eptifibatide) Injection in 2,400 patients undergoing coronary intervention with stenting has been halted early after an almost 50 percent reduction in death or heart attack at 30 days at an interim analysis.

The results of the interim analysis were reviewed by an independent Data Safety Monitoring Committee (DSMC) which determined that the study should be stopped due to the highly significant reduction in the combined incidence of death or myocardial infarction with INTEGRILIN compared with placebo over 30 days (P=0.0011) following a stenting procedure. A significant reduction was seen as early as 48 hours (P=0.0017) in the interim analysis of 1,758 patients.

Consistent with the DSMC's charter, the committee also assessed the safety profile of INTEGRILIN and concluded that there was no difference in the incidence of severe bleeding events between INTEGRILIN and placebo. There was a modest increase in the incidence of moderate bleeding with INTEGRILIN.

&uot;Given the dramatic reduction in clinically serious outcomes achieved, the committee unanimously agreed that the placebo patients should not be denied access to this type of therapy,&uot; stated Robert M. Califf, MD, Associate Vice Chancellor for Clinical Research at Duke University Medical Center and Director of the Duke Clinical Research Institute, the coordinating center for the study conducted at over 90 sites in the United States and Canada. &uot;The results of this study reinforce our conviction that GP IIb-IIIa inhibitors should be the standard of care for patients undergoing intracoronary stenting. We now have convincing evidence that INTEGRILIN represents a highly efficacious therapy for these vulnerable patients.&uot;

&uot;We can now achieve a robust reduction in death or MI associated with intracoronary stenting, coupled with the reversibility and affordability of INTEGRILIN,&uot; stated James E. Tcheng, MD, Assistant Professor of Medicine at Duke University Medical Center and lead investigator for ESPRIT. Review of the specific data from the study will be made public at an upcoming scientific forum.

The ESPRIT (Enhanced Suppression of Platelet Receptor GP IIb-IIIa using INTEGRILIN Therapy) study was designed to assess the efficacy and safety of INTEGRILIN in patients undergoing non-urgent percutaneous coronary intervention with the wide variety of intracoronary stents currently used in clinical practice. In ESPRIT, INTEGRILIN was dosed as a 180 ug/kg bolus, immediately followed by a 2 ug/kg/min infusion, then followed by a second 180 ug/kg bolus 10 minutes later. The infusion was continued until hospital discharge for up to 18-24 hours. The primary endpoint of the study was the combined incidence of death, MI, urgent repeat intervention, or need for bail-out GP IIb-IIIa inhibitor therapy at 48 hours. Secondary endpoints included the composite endpoint, as well as the composite of death, MI, or urgent repeat revascularization, at 12 hours, 24 hours, 7 days, and 30 days.

Over 500,000 percutaneous coronary interventions (PCI) are performed in the U.S. each year to restore blood flow through occluded arteries that supply oxygen to heart muscle. More than sixty percent of all PCI procedures employ the use of intracoronary stents, metal mesh structures that hold the artery open after the procedure. Although PCI and intracoronary stenting are generally successful at restoring blood flow and preventing the collapse of the artery, the deployment of the stent into the artery wall can result in the clumping of blood cells called platelets and the development of an intracoronary thrombus or blood clot. Because the thrombus can obstruct blood flow through the artery and thus deprive the heart muscle of oxygen supply, myocardial infarction (heart attack) or death can occur.

INTEGRILIN(R) (eptifibatide) Injection helps prevent heart attack and death by blocking certain receptors, known as GP IIb-IIIa, on platelets that are responsible for thrombus development. The effects of INTEGRILIN, a small molecule GP IIb-IIIa inhibitor, are specific to platelets and thus do not interfere with other normal cardiovascular processes and can be reversed upon INTEGRILIN discontinuation.

INTEGRILIN is currently indicated for the treatment of patients with acute coronary syndrome (unstable angina and non-Q-wave myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention. It is also indicated for the treatment of patients undergoing PCI.

INTEGRILIN is contraindicated in patients with a history of bleeding diathesis, or evidence of abnormal bleeding within the previous 30 days; severe hypertension (systolic blood pressure greater than 200 mm Hg or diastolic blood pressure greater than 110 mm Hg) not adequately controlled on antihypertensive therapy; major surgery within the preceding six weeks; history of stroke within 30 days, or any history of hemorrhagic stroke; current or planned administration of another parenteral GP IIb-IIIa inhibitor; platelet count less than 100,000/mm3; serum creatinine greater than or equal to 4.0 mg/dL (in patients with serum creatinine levels between 2.0 mg/dL and 4.0 mg/dL, a 135 ug/kg bolus and 0.5 ug/kg/min infusion should be administered); dependency on renal dialysis; or known hypersensitivity to any component of the product.

Previous studies have shown that bleeding is the most common complication encountered during INTEGRILIN therapy. The majority of excess major bleeding events were localized at the femoral artery access site. Oropharyngeal, genitourinary, gastrointestinal and retroperitoneal bleeding were also seen more commonly with INTEGRILIN compared to placebo.

COR Therapeutics, Inc. and Schering-Plough Corporation are worldwide partners for INTEGRILIN. Both companies market and sell the drug in the United States. Schering-Plough markets INTEGRILIN in Europe. COR has the right to co-promote INTEGRILIN in Europe at a later date.

COR Therapeutics, Inc. is dedicated to the discovery, development, and commercialization of novel pharmaceutical products for the treatment and prevention of severe cardiovascular diseases.

Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing, and marketing of pharmaceutical products worldwide.

COR forward-looking statement: In addition to the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Actual results of the Company's activities may differ significantly from the potential results discussed in such forward-looking statements. These forward-looking statements are based on current expectations and the Company assumes no obligation to update this information. A full discussion of COR Therapeutics' operations and financial condition, and specific factors that could cause the Company's actual performance to differ from current expectations, can be found in the Company's SEC reports, including, but not limited to, the Company's Report on Form 10-Q for the quarter ended September 30, 1999, and Report on Form 10-K for the year ended December 31, 1998.

INTEGRILIN(R) is a registered trademark of COR Therapeutics, Inc.
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Publication:Business Wire
Geographic Code:1USA
Date:Feb 4, 2000
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