Diosynth Biotechnology signed an extension of its exclusive agreement with PDL BioPharma, Inc. 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 (AMI) 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.
"We are very excited about the opportunity to continue our successful relationship with PDL BioPharma and appreciate their recognition of the efforts of our team here in RTP," said Jacques van Kimmenaede, President of Diosynth Biotechnology. Van Kimmenaede added, "The agreement to continue the supply of Retavase is an excellent demonstration of our commitment to cGMP 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 U.S. or in our biomanufacturing facilities in Oss, Netherlands."
Diosynth Biotechnology offers contract cGMP manufacturing of biopharmaceuticals. The company serves its customers by applying a full set of capabilities that range from cell line development to clinical and commercial manufacturing of both fermentation and cell culture derived drug substance, through fill and finish of drug product.
For more information contact:
Mr. Rob Gustines
Director, Marketing & Business Alliances
Ph: +1-919-337-4425
Email: rob.gustines@diosynth-rtp.com
Diosynth Biotechnology is a division of Organon that supplies contract manufacturing services for the global biotechnology industry. The company has an 80-year heritage in biologics manufacturing and is a global leader in technology-driven process development and cGMP manufacturing of recombinant proteins, monoclonal antibodies and peptides. We help our customers succeed by developing scalable and robust processes and by driving products efficiently, rapidly and cost-effectively from preclinical development to market supply. Diosynth Biotechnology serves pharmaceutical and biopharmaceutical customers globally and operates FDA-, Health Canada- and EMEA-inspected cGMP manufacturing facilities in Research Triangle Park, NC USA, and Oss, the Netherlands. Diosynth Biotechnology is part of Akzo Nobel's human healthcare business unit Organon. The Akzo Nobel Safe Harbor Statement (below) applies to this press release. For more information: http://www.diosynthbiotechnology.com/
Diosynth Safe Harbor Statement*
This press release may contain statements which address such key issues as the Akzo Nobel growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements, including but not limited to the "Outlook", should be carefully considered and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. These factors also include changes in regulations or interpretations related to the implementation and reporting under IFRS, decisions to apply a different option of presentation permitted by IFRS, and various other factors related to the implementation of IFRS, including the implementation of IAS 32 and 39 for financial instruments. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more complete discussion of the risk factors affecting our business please refer to the Akzo Nobel Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the Akzo Nobel website.
* Pursuant to the U.S. Private Securities Litigation Reform Act 1995.


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