Abstract

Amediplase [CGP 42935, MEN 9036, K2tu-PA] is a recombinant chimeric plasminogen activator, consisting of the kringle 2 domain from the A-chain of tissue plasminogen activator (t-PA) and the carboxy terminal region of pro-urokinase. Amediplase was the outcome of a collaborative project with Ciba Geigy (now Novartis), but subsequent preclinical and clinical development has been completed by Menarini. Menarini is currently investigating amediplase in phase III clinical trials in Europe as a thrombolytic given as a single bolus to patients with myocardial infarction. In June 2002, Prometic Life Sciences announced that its collaboration with Menarini Biotech had resulted in the discovery of a scaleable manufacturing process for amideplase, based on Prometic's Mimetic Ligand- technology; amideplase manufactured by this process is expected to be used in the phase III studies.

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