PVG.L Regulatory News (PVG)

24 Jun 2009 07:00



Ark announces major advance in adenoviral gene-based medicine production

London, UK, 24 June 2009 - Ark Therapeutics Group plc ('Ark' or the 'Company') announces today that it has made a major advance in its production technology and processes for commercial manufacture of adenoviral gene-based medicines. Ark's production development group in Kuopio, Finland, has developed a suspension process based on single use systems (SUS) for manufacturing commercial sized batches of adenoviral gene-based medicines ready for fill.

SUS is based on disposable wavebag and membrane-based purification processing technology, and allows use of the reversing flow system invented by Ark. The new process has resulted in a very high quality finished product with improved yields of up to 100 times those achieved by more conventional adherence cell or non-disposable bioreactor suspension cell culture and chromatographic purification processes.

The SUS system occupies a quarter of the space previously needed for conventional production and, being disposable, results in considerable cost and time savings with reduced facility and equipment sterilisation 'down time'. The extensive use of contained process elements opens up hitherto product-specific production theatres for potential manufacture of more than one product line.

The Company's new facility (GMP 3), was designed around SUS production and is expected to be fully validated in early 2010 giving Ark significantly enhanced production capacity.

Robert Shaw, Operating Board member responsible for technical services at Ark, commented: "These material improvements to our manufacturing capabilities enable us to move from a continuously running commercial supply process, which was both labour and facility intensive, to a system where we can see yields of 5,000-20,000 doses in a single short run. This is a major step forward for us and the gene-based medicine sector."

Dr Nigel Parker, CEO of Ark, added: "The SUS system will have a significant impact on production and ultimately cost of goods and we have strong intellectual property to protect our competitive advantage. We believe this process will work with all adenoviral gene-based products and is adaptable to other types of virus for gene medicine production."

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Notes to Editors

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 five marketed devices, Kerraboot®, Kerraped®, Flaminal®, Neuropad® and KerraMax® 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 both 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, where 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 Ylä-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.