London, UK, 8 July 2008 – Ark Therapeutics Group plc (“Ark” or the “Company”) today announces that it has opened its new commercial-scale manufacturing facility (GMP 3) in Kuopio, Finland. The facility, built as a result of a co-operative agreement between the Company and the University business park, is an advanced, state-of-the-art construction, linked to Ark’s existing manufacturing and laboratory suites. It has been specifically designed for the manufacture of gene-based medicines, particularly those in viral vector constructs, and will operate to Biosafety Level Two (BSL2). Containing 547m2 of clean rooms, it has taken three years to build and has been completed on schedule and on budget. Engineering fit-out of the basic manufacturing environment was carried out by Novo Nordisk Engineering Pharmaplan of Denmark (“NNE”).
The facility will initially be used for laboratory and pre-clinical grade production while equipping and validating dedicated production theatres to enable full GMP certification continues. This facility adds to the capabilities of Ark’s existing production units (GMP 1 and GMP 2) and will allow the Company to be fully self-sufficient for manufacture of all the gene-based products in its portfolio, including Cerepro® (for glioblastoma) and Trinam® (for haemodialysis graft access surgery), for research, clinical trial and commercial supply.
Investment by Ark of Euro 10 million in the highly specialised gene-based manufacturing suites of this facility has been assisted by Euro 2.19 million of grant support from The Employment and Economic Development Centre of Finland (‘TE-Centre’). This is the largest investment grant awarded to the Biotech-Pharma Industry by the TE-Centre since its foundation in 2000.
Robert Shaw, Technical Director at Ark, commented: “This is a very high grade facility which is complementary to Ark’s existing manufacturing capabilities in Kuopio and enables the Company to take advantage of the quality science and technology in Finland. As regulatory standards increase, it is essential that Ark has the internal capability to manufacture at all levels so it can ensure quality standards are set, achieved and maintained throughout all phases of the product development cycle.”
Nigel Parker, CEO of Ark, added: “With its own manufacturing facilities, Ark will not only have control over the production process but most importantly it will enable the Company to retain the whole of the profit margin on what we believe will be highly valuable products. This is a great achievement for the Ark and NNE teams in Finland and is another strong step forward for the Company, strengthening our whole gene-based platform and giving us stability for the future.”
For further information:
Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722 Dr Nigel Parker, CEO Martyn Williams, CFO
Financial Dynamics Tel: +44 (0)20 7831 3113 David Yates Susan Quigley
