RETAVASE® (reteplase) is a recombinant plasminogen activator which catalyzes the cleavage of endogenous plasminogen to generate plasmin. Plasmin degrades the fibrin matrix of the thrombus, exerting its thrombolytic action.

Established safety profile in clinical trials

The safety of RETAVASE® (reteplase) was studied in the RAPID 2, RAPID 1, and INJECT clinical trials.

In these studies, the severity and sites of bleeding events were similar for RETAVASE and the comparison thrombolytic agents.

RAPID 21

RAPID 2 was designed to detect differences in patency and was not powered to detect differences in adverse clinical outcomes.

Adverse clinical outcomes ≤35 days after treatment

Total stroke¹ Death and nonfatal, disabling stroke¹ Reinfarction¹ Congestive heart failure¹ Ischemia/ angina¹ Shock² Death­­¹ Variable RETAVASE 10 + 10 unitn=169 4.1% 1.8% 5.3% 4.7% 9.5% 29.0% 5.3%

The composite endpoint of unsatisfactory outcomes* ≤35 days after treatment was observed in 21.3% of patients in the RETAVASE 10 + 10 unit group.

*The composite endpoint of unsatisfactory outcomes included death, reinfarction, congestive heart failure, or shock and/or an ejection fraction of <40% at predischarge evaluation.

Bleeding complications ≤35 days after treatment

Bleedings requiring transfusions (excluding during surgery) Bleedings requiring transfusions (excluding during surgery and puncture site) Intracranial bleeding Variable RETAVASE 10 + 10 unit n=169 1.2% 12.4% 5.3%

Study Design

Study Design



Randomized, controlled, open-label study Europe and the US Protocol Patient population Study type Study location Purpose Primary endpoint RAPID 2 1,4 RAPID 1 3,4 RAPID studies 1,3,4 Compare coronary artery patency after treatment with RETAVASE vs alteplase Patency, defined as TIMI 2 or 3 flow of the infarct-related artery, 90 minutes after initiation of therapy Secondary endpoint Patency by TIMI flow grade at 30 and 60 minutes and 5 to 14 days after initiation of therapy • N=303 • Patients with STEMI • N=287‡ • Patients with STEMI • Within 12 hours of the onset of symptoms, patients were randomized to open-label administration of either: – RETAVASE 10 + 10 unit or – Alteplase 100 mg over 1.5 hours • Coronary angiogram interpretation was blinded • Within 6 hours of the onset of symptoms, patients were randomized to open-label administration of either: – 1 of 3 regimens of RETAVASE (doses of 10 + 10 unit, 15 unit, or 10 + 5 unit) or – Alteplase 100 mg over 3 hours • Coronary angiogram interpretation was blinded Key inclusioncriteria Key exclusion criteria Patients >18 years old with ≥30 minutes of typical chest pain that was not relieved by nitroglycerin and ST-segment elevation of ≥0.1 mV in two of three inferior or lateral leads or ≥0.2 mV in at least two contiguous precordial leads or left bundle-branch block and presenting within ≤ 12 hours from onset of ischemic chest pain to the planned administration of treatment Patients 18 to 75 years old with at least 30 minutes of typical chest pain not relieved by nitroglycerin and ST-segment elevation of of 0.1 mV in the the inferior or lateral leads or 0.2 mV in the precordial leads and presenting <6 hours after onset of chest pain Prior coronary artery bypass graft surgery, previous stroke or known intracranial structural abnormalities, previous percutaneous transluminal coronary angioplasty within 2 weeks, previous Q-wave myocardial infarction in the same anatomic region as the qualifying infarction, or severe hypertension (>180/110 mmHg) not rapidly responding to treatment, concomitant use of oral anticoagulation therapy ECG demonstrat- ing left bundle branch block, prior coronary bypass surgery, previous Q-wave myocardial infarction in the same anatomic region, previous percutaneous transluminal cor- onary angioplasty (PTCA) within 2 weeks, previous cerebral vascular accident, or severe hyperten - sion with a systolic blood pressure >180 or diastolic blood pressure >110 mmHg at presentation to hospital

‡Represents the number of patients in the 10 + 10 RETAVASE arm plus the alteplase arm. The total number of patients enrolled in RAPID 1 was 606.

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RAPID 13

RAPID 1 was designed to detect differences in patency and was not powered to detect differences in adverse clinical outcomes.

Adverse clinical outcomes within 30 days