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Vernalis Signs Agreement with Diosynth Biotechnology for Phase III Manufacture of V10153
Thursday, September 22, 2005
RESEARCH TRIANGLE PARK, N.C. (Business Wire) -- Vernalis Plc has signed a contract with Diosynth Biotechnology for process development, scale-up and manufacturing of V10153 for Phase III clinical trials.
The process development and manufacturing agreement will see Vernalis transfer the manufacturing process developed by the company to the Research Triangle Park facility of Diosynth Biotechnology for further process refinement and cGMP manufacturing commencing immediately. The Diosynth Biotechnology facility has been inspected by the FDA and EMEA. The goal of the collaboration is to complete cGMP Manufacture before the end of 2006.
"We are pleased to be working with Vernalis," said Frank Tielens, President of Diosynth Biotechnology. "We continue to be selected for phase III and commercial supply for important biopharmaceutical products, which emphasizes our solid process development, cGMP manufacture, quality and regulatory capabilities."
V10153 is a novel thrombolytic agent that is being investigated in a Phase II study in Canada and the US in patients who have recently experienced an acute ischaemic stroke. V10153 is a modified version of human plasminogen, a naturally occurring protein, which, when activated, is responsible for dissolving blood clots in the body. The structural modification to V10153 is designed to target the drug at newly-formed blood-clots while leaving older clots unaffected, potentially reducing the risk of unwanted bleeding at other sites. V10153's safety profile to-date indicates that it has potential to extend thrombolytic treatment in stroke and other major thrombotic diseases. These include acute myocardial infarction (AMI), peripheral arterial occlusion, pulmonary embolism and deep vein thrombosis. In particular, V10153 has the potential to be effective and safe for use for a longer period after the onset of a stroke, enabling a broader group of patients to receive treatment.
Diosynth Biotechnology
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.
Diosynth Biotechnology
Richard Basile, 919-337-4305
Dick.Basile@diosynth-rtp.com
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