The announcement follows the recent publication of clinical data from Phase II trials demonstrating the potential of ZD4522, a HMG-CoA reductase inhibitor, to be a highly effective and well-tolerated alternative to currently available statins.
Work has already started on the new plant to manufacture ZD4522. It is being built using a novel project strategy involving an alliance team of design and construction contractors to enable completion to an accelerated programme. AstraZeneca is providing in-house project and construction management, process development and commissioning services.
The plant will be staffed by 19 new employees and will be operational by the middle of next year (2001).
Dr. Barrie Thorpe, Executive Vice-President of Operations, said: "The construction of the new plant for ZD4522 is on a fast-track timescale like the rest of the programme to bring this exciting potential megabrand to market. The plant is leading edge with equipment to meet the latest UK environmental standards and to provide the best possible manufacturing standards."
The first submissions to regulatory authorities for ZD4522 are expected in 2001 with first launches due for the second half of 2002. AstraZeneca licensed worldwide rights to the treatment from Shinogi & Co in April 1998, and completed the entire Western Phase I and II clinical trial programme in just eight months, which is believed to be a record time for any primary care product. ZD4522 is currently in Phase III.
The latest announcement brings the total investment in ZD4522 at Avlon Works to £36m. AstraZeneca made an initial investment of £7.5m in a new purification plant to handle their new statin in February last year (1999). This plant has recently been successfully commissioned and has become operational.
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Steve Brown +44 (0)20 7304 5033
Lucy Williams +44 (0)20 7304 5034
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- AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products.
- Substantial clinical evidence has led statins to be regarded as first-line therapy for patients with atherosclerotic vascular disease. This is a common cause of cardiovascular disease, the world's leading cause of death.
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