PVG.L Regulatory News (PVG)

13 Feb 2008 07:00

Ark Therapeutics Group PLC13 February 2008 Ark completes work to validate its GMP gene medicine production facility to USstandards 13 February 2008 - Ark Therapeutics Group plc ("Ark" or the "Company") announcestoday that it has completed the detailed review of facility validation anddocumentation upgrades to enable its Finnish gene therapy manufacturing facilityto meet US as well as European Good Manufacturing Practice (GMP) standards. Ark's facility was approved in late 2005 by the Finnish National Agency forMedicines (NAM) on behalf of the European Medicines Evaluation Agency (EMEA) asthe first ever facility to be allowed to manufacture adenoviral gene-basedmedicines for commercial supply in Europe. The facility passed its firstroutine NAM inspection in 2007 demonstrating Ark's success in maintaining theproduction standards over time. This recent upgrade brings the facility'sengineering validations and documentation standards into line with therequirements needed for US commercial supply. The project has taken seven months to complete and was overseen by the head ofthe international manufacturing and production consultancy Maijatech, a widelyexperienced GMP inspector who recently worked with the WHO inspectorate. Robert Shaw, Technical Director at Ark, commented: "This has been a meticulousexercise scrutinising and evaluating our facility manufacturing documentationback to the late 1990's and our recent facility compliance. To be able to showthe history of continuous improvements to the production process as manufacturedproducts move through their development life cycle is one of the criticalelements in GMP and demonstrates the quality of Ark's facilities and thecompetence of its staff in Finland." Dr Nigel Parker, CEO of Ark commented: "We are now confident that, subject topositive pre-approval inspections of an individual product's dedicatedproduction line, we can manufacture gene-based medicines for both EU and UScommercial supply. This is a solid achievement for Ark." Enquiries Ark Therapeutics plc Tel: +44 (0)20 7388 7722Dr Nigel Parker, Chief Executive OfficerMartyn Williams, Chief Financial Officer Financial Dynamics Tel: +44 (0)20 7831 3113David Yates / Sue Quigley 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, woundcare and cancer. These are large and growing markets, where opportunities existfor effective new products to generate significant revenues. With threemarketed devices, Kerraboot(R), Kerraped(R) and Flaminal(R), and three furtherlead pharmaceutical products in late stage clinical development: Cerepro(R),VitorTM, and Trinam(R), the Group is transitioning from an R&D company to acommercial, revenue generating business. Ark's own products are sourced from related but largely non-dependenttechnologies within the Group and have been selected to enable them to be takenthrough development within the Group's own means and to benefit from Orphan DrugStatus and/or Fast Track Designation, as appropriate. This strategy has allowedthe Group to retain greater value and greater control of clinical developmenttimelines, and to mitigate the risks of dependency on any one particularprogramme or development partner. Ark has secured patents or has patentapplications pending for all its lead products in principal pharmaceuticalmarkets. Ark has its origins in businesses established in the mid-1990s by Professor JohnMartin and Mr Stephen Barker of University College London and Professor SeppoYla-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland,all of whom play leading roles in the Company's research and developmentprogrammes. Ark's shares were first listed on the London Stock Exchange in March 2004(AKT.L). This announcement includes "forward-looking statements" which include allstatements other than statements of historical facts, including, withoutlimitation, those regarding the Group's financial position, business strategy,plans and objectives of management for future operations (including developmentplans and objectives relating to the Group's products and services), and anystatements preceded by, followed by or that include forward-looking terminologysuch as the words "targets", "believes", "estimates", "expects", "aims","intends", "will", "can", "may", "anticipates", "would", "should", "could" orsimilar expressions or the negative thereof. Such forward-looking statementsinvolve known and unknown risks, uncertainties and other important factorsbeyond the Group's control that could cause the actual results, performance orachievements of the Group to be materially different from future results,performance or achievements expressed or implied by such forward-lookingstatements. Such forward-looking statements are based on numerous assumptionsregarding the Group's present and future business strategies and the environmentin which the Group will operate in the future. Among the important factors thatcould cause the Group's actual results, performance or achievements to differmaterially from those in forward-looking statements include those relating toArk's funding requirements, regulatory approvals, clinical trials, reliance onthird parties, intellectual property, key personnel and other factors. Theseforward-looking statements speak only as at the date of this announcement. TheGroup expressly disclaims any obligation or undertaking to disseminate anyupdates or revisions to any forward-looking statements contained in thisannouncement to reflect any change in the Group's expectations with regardthereto or any change in events, conditions or circumstances on which any suchstatements are based. As a result of these factors, readers are cautioned not torely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange