Diosynth Biotechnology, a US division of Dutch group Organon, signed an extension of its exclusive agreement with USA-based PDL BioPharma for the commercial manufacture of Retavase (reteplase), a fibrinolytic agent that has been marketed in North America since October 1996. Retavase is indicated for use in the management of acute myocardial infarction in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure, and the reduction of mortality associated with AMI.
Jacques van Kimmenaede, president of Diosynth, said: "the agreement to continue the supply of Retavase is an excellent demonstration of our commitment to current Good Manufacturing Practice production of commercial biologics. We not only manufacture commercial products but we also apply our process development expertise to projects in clinical development and can carry those projects all the way through Regulatory Applications for our customers. We can do this either in the USA or in our biomanufacturing facilities in Oss, the Netherlands."
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