8th Jul 2008 11:00
Ark Therapeutics Group plc
Ark opens new manufacturing facility in Finland
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:
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Ark Therapeutics Group plc |
Tel: + 44 (0)20 7388 7722 |
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Dr Nigel Parker, CEO |
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Martyn Williams, CFO |
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Financial Dynamics |
Tel: +44 (0)20 7831 3113 |
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David Yates |
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Susan Quigley |
Notes to Editors
Technical details of New GMP3 Facility
The products made in this facility will be based on modified live viral particle technologies. The manufacturing process will cover the whole production process, from biological bulk manufacture, through purification to filling and packaging of finished sterile product.
The layout of the facility includes two serviced manufacturing suites, and a separate filling area with full vial washing, depyrogenation and filling equipment for filling of the product. The packaging area includes vial decontamination equipment, visual inspection, labelling and packaging for the vials. Clean service areas for washing and sterilizing are located by the production areas. Each of the BSL2 rooms is equipped with the possibility to decontaminate the room with Hydrogen Peroxide Vapor.
The Heating, Ventilation and Air-Conditioning (HVAC) has been designed to provide 100% fresh air to BSL2 areas where the production of viral based product is performed. Both incoming and outgoing air in the whole facility is HEPA filtered ensuring the cleanness of the environment. Pressure zones in the facility are designed to let the air flow from clean to less clean areas. Continuous monitoring of the non-viable particles and pressure differences is performed by the validated Facility Monitoring System.
Other utilities needed for the process such as plant steam, clean steam, compressed air, water for injection and the waste inactivation system for liquid waste are located in the basement.
Solid waste from the BSL2 area can be inactivated in the waste autoclave and the liquid waste will be drained to the waste inactivation system in the basement.
The design allows for the later addition of a second production suite on the first floor with no disruption to on-going production.
Ark has worked closely with environmental authorities receiving an Environmental certificate earlier in 2008 for the whole of its Research, Development and Manufacturing operation in Finland.
About Ark Therapeutics Group plc
Ark Therapeutics Group plc is a specialist healthcare group (the "Group") addressing high value areas of unmet medical need within vascular disease, wound care and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues. With four marketed devices, Kerraboot®, Kerraped®, Flaminal® and Neuropad®, and three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam®, the Group is transitioning from an R&D company to a commercial, revenue generating business.
Ark's own products are sourced from related but largely non-dependent technologies within the Group and have been selected to enable them to be taken through development within the Group's own means and to benefit from Orphan Drug Status and/or Fast Track Designation, as appropriate. This strategy has allowed the Group to retain greater value and greater control of clinical development timelines, and to mitigate the risks of dependency on any one particular programme or development partner. Ark has secured patents or has patent applications pending for all its lead products in principal pharmaceutical markets.
Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Mr Stephen Barker of University College London and Professor Seppo Yla-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland, all of whom play leading roles in the Company's research and development programmes.
Ark's shares were first listed on the London Stock Exchange in March 2004 (AKT.L).
This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.
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