Iroko Cardio International Sàrl Commences Operations and Appoints Dr. Jürgen Raths as President and CEO

GENEVA--(BUSINESS WIRE)--Dr. Jürgen Raths has been appointed President and CEO of Iroko Cardio International Sàrl, a newly created business entity focusing on the commercialization of Aggrastat® (Tirofiban) world-wide outside the USA. Iroko Cardio International operates out of Geneva, Switzerland.

Dr. Raths has held various medical, commercial and general management roles in the field of pharmaceutical specialty products in Europe and the USA. As Head of Critical Care Europe, he built up the first pan European business unit at Eli Lilly, focused on providing highly specialized clinical customers such as interventional cardiologists and intensive care clinicians with best in class scientific and commercial services. Recently, he served as CEO of Arpida, a public Swiss biotech company that he successfully led through a merger.

He will be supported by IROKO Cardio LLC which continues operations out of Philadelphia.

"We are very happy that Jürgen has taken on the leadership role for Aggrastat®," Bert van den Bergh, executive Chairman of Iroko Cardio LLC noted. "We are convinced that Jürgen can build a winning team around our franchise and further develop the brand in close cooperation with our world-wide partners."

About Aggrastat®:

Important Information About AGGRASTAT® Injection

AGGRASTAT® (tirofiban hydrochloride) is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes. Patients most likely to benefit from AGGRASTAT® treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including, for instance, those that are likely to undergo an early PTCA.

In most patients, AGGRASTAT® should be administered intravenously, at an initial rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min. For complete information, please refer to the product's prescribing information. AGGRASTAT® is intended for use with acetylsalicylic acid and unfractionated heparin.

AGGRASTAT® is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial haemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT® include a history of thrombocytopenia following prior exposure to AGGRASTAT®, history of stroke within 30 days or any history of haemorrhagic stroke, major surgical procedure or severe physical trauma within the previous month, or history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT® is also contraindicated in patients with severe hypertension (systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg), concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.

Bleeding is the most common complication encountered during therapy with AGGRASTAT®. Administration of AGGRASTAT® is associated with an increase in bleeding events, classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catheterisation. Fatal bleedings have been reported. AGGRASTAT® should be used with caution in patients with platelet count <150,000/mm3, in patients with haemorrhagic retinopathy, and in chronic haemodialysis patients. Because AGGRASTAT® inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect haemostasis. The safety of AGGRASTAT® when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT®, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT® and heparin should be discontinued.

The following additional adverse reactions have been reported in post-marketing experience: bleeding, intracranial bleeding, retroperitoneal bleeding, haemopericardium, and pulmonary (alveolar) haemorrhage. Fatal bleedings have been reported; body as a whole: acute and/or severe decreases in platelet counts which may be associated with chills, low grade fever, or bleeding complications; hypersensitivity; rash and/or hives.

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