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| |  Integrilin (Eptifibatide) Injection Plus Clopidogrel Appears to Provide Superior Platelet Inhibition and Reduced Heart Muscle Death CAMBRIDGE, MA -- March 1, 2005 -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) announced final results from the CLEAR Platelets (Clopidogrel Loading with Eptifibatide to Arrest the Reactivity of Platelets) trial. The study assessed low-to-moderate risk patients and showed that addition of Integrilin, a potent glycoprotein (GP)IIb-IIIa inhibitor, to clopidogrel provided superior platelet inhibition and prevention of heart muscle damage associated with elective coronary stenting versus clopidogrel alone. Heart muscle damage, assessed by measuring cardiac biomarkers, has been previously linked to mortality in percutaneous coronary intervention (PCI).(1) The study results from CLEAR Platelets were published today in the journal Circulation: Journal of the American Heart Association. "We have previously reported data suggesting that the use of clopidogrel in patients undergoing elective coronary artery stenting does not provide sufficient platelet inhibition in some patients. The CLEAR Platelets study assessed whether Integrilin can overcome the limitations of clopidogrel early, after stenting, with adjunctive therapy," said Paul Gurbel, MD, principal investigator in the CLEAR Platelets study. Dr Gurbel is director of Sinai Center for Thrombosis Research at Sinai Hospital of Baltimore and associate professor at Johns Hopkins University, Baltimore. "Our findings suggest that using a GPIIb-IIIa inhibitor, such as Integrilin, with clopidogrel may provide a superior treatment strategy versus clopidogrel alone in providing platelet inhibition in PCI. CLEAR Platelets supports the importance of adequate and sustained platelet inhibition in preventing heart muscle death following elective stenting." CLEAR Platelets is the first prospective, randomized, open-label study ever conducted to investigate the effect of adding Integrilin to varying clopidogrel dosing regimens. The relation of platelet inhibition to heart muscle damage associated with elective coronary stenting was also evaluated. All patients (n=120) received daily aspirin (81mg) for seven days prior to stenting and 325 mg the day of the procedure. Heparin (60 U/kg, bolus) was administered in all patients in the catheterization laboratory. Patients were randomized to one of four treatment groups: clopidogrel (300 mg), clopidogrel (600 mg), and each clopidogrel dose in combination with Integrilin (180 mcg/kg, double bolus, followed by 2 mcg/kg/min infusion for 18-24 hours). Post-stenting, 75 mg of clopidogrel was given daily in all patients. The following results were reported: * Both Integrilin treatment regimens demonstrated significantly lower platelet reactivity over 18-24 hours compared to treatment with clopidogrel alone (p<0.001). * The Integrilin treatment arms had significantly reduced release of cardiac markers for heart muscle damage compared to clopidogrel alone, CK-MB (p<0.005), troponin I (p=0.004), and myoglobin (p=0.002). * A significant correlation was observed between post-treatment platelet reactivity and evidence of heart muscle damage as assessed by cardiac necrosis biomarkers (p<0.001). * One nonfatal bleed in each of the Integrilin groups and one stent thrombosis in the 300 mg clopidogrel alone group were observed. "Results of the CLEAR Platelets trial support the incremental clinical value of including GPIIb-IIIa inhibitors such as Integrilin for even low and moderate risk PCI patients who are benefiting from other new technologies and therapeutic approaches that, like Integrilin, can help improve outcomes," said Arthur Hiller, senior vice president, sales and marketing at Millennium. Final results from CLEAR Platelets as well as other studies assessing Integrilin in the PCI setting will be presented at the American College of Cardiology Annual Meeting in Orlando, Fla. March 6-9, 2005. About Integrilin® (eptifibatide) Injection 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 GPIIb-IIIa inhibitor; dependency on renal dialysis; or known hypersensitivity to any component of the product. Bleeding is the most common complication encountered during Integrilin therapy. In the registration trials, 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. For inquiries about Integrilin, patients and physicians can call 1-(888)- 267-4MED. Integrilin is co-promoted and co-developed by Millennium Pharmaceuticals, Inc. and Schering-Plough Corporation in the U.S. and GlaxoSmithKline PLC in Europe. Reference: (1) Newby LK et. al. Circulation 1998, 98: 1853-1859.
SOURCE: Millennium Pharmaceuticals, Inc.
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