Agenix Starts Process for Commercial Scale Manufacture of ThromboView(R) with Diosynth Biotechnology.MORRISVILLE, N.C. -- Agenix Limited has signed a contract with Diosynth Biotechnology, a division of Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. , the human healthcare business unit of Akzo Nobel, one of the world's leading companies in healthcare products, coatings and chemicals, to begin the process of manufacturing ThromboView(R) for Phase III clinical trials and commercial sale. Over the past twelve months, in conjunction with Florian Wurm PhD, Chief Science Officer of ExcellGene SA. in Monthey Switzerland, and his team, Agenix has been able to increase the productivity of the cell line ten-fold, resulting in smaller scale commercial manufacture and significant economic benefits. The process development and manufacturing agreement will see Agenix transfer the manufacturing process developed by the company to the Research Triangle Park Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. facility of Diosynth Biotechnology for further process refinement and cGMP manufacturing commencing immediately. The Diosynth Biotechnology facility has been inspected by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. . The goal of the collaboration is to enable Agenix to supply cGMP material for Phase III clinical trials by the third quarter of next year. "This is a very important milestone in the ThromboView(R) program and we are pleased to have engaged an experienced company with a successful track record in the transfer and manufacture of biotechnology products," said Agenix Managing Director Donald Home. "Given the promising results we have seen from the clinical trials completed so far we remain confident in both the clinical need and performance for this product. With this manufacturing transfer we will be able to continue to drive the clinical development and deliver as per our timeline." "We are pleased with Agenix's confident selection of Diosynth Biotechnology and excited to apply our process development and manufacturing expertise toward the commercialization of this innovative product," said Frank Tielens, President of Diosynth Biotechnology. Recruitment for the Phase Ib PE (pulmonary embolism Pulmonary Embolism Definition Pulmonary embolism is an obstruction of a blood vessel in the lungs, usually due to a blood clot, which blocks a coronary artery. ) safety trial in Australia has commenced with 4 patients now successfully enrolled out of the planned 14. The Phase II DVT See deep vein thrombosis. (deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. ) trial in the United States and Canada is underway and has recruited 32 patients. There is an interim analysis of this trial planned after 50 patients have been recruited. The first patient in that trial was recruited in early March 2005. Agenix plans to conclude a Sales, Marketing and Distribution agreement by the end of this calendar year and the manufacturing transfer and the results of the ongoing studies are key components of this agreement. Agenix Limited (ASX ASX See: Australian Stock Exchange : AGX; OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on ): AGXLY) is a global health and biotechnology company based in Brisbane, Australia. The Company runs a suite of established businesses in human and animal health diagnostics, and is focused on growing its world-leading molecular diagnostic imaging R&D program. Agenix's lead candidate is its high-technology ThromboView(R) blood clot-imaging project, which is currently undergoing Phase II human trials in the United States and Canada. ThromboView(R) uses radiolabelled antibodies to locate blood clots in the body, and could revolutionise the US $3 billion global clot diagnostic imaging market. ThromboView(R) is being developed with the assistance of the Federal Government through its START scheme. Agenix employs 110 staff and sells its products to more than 50 countries. ThromboView(R) is a registered trademark of AGEN Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. , a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Agenix Limited. www.agenix.com 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 IFRS International Financial Reporting Standard(s) IFRS Inter Frame Relay Service IFRS Indiana Facilities Registry System , 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 See iPlanet Application Server. 1. (computer) IAS - The first modern computer. It had main registers, processing circuits, information paths within the central processing unit, and used Von Neumann's fetch-execute cycle. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 1995. |
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