PVG.L Regulatory News (PVG)

20 Oct 2005 07:00

Ark Therapeutics Group PLC20 October 2005 Ark receives licence to manufacture first gene medicine for commercial supply London, UK, 20 October 2005: Ark Therapeutics Group plc ("Ark") announces todaythat, following an inspection by the Finnish National Agency for Medicines, onbehalf of the European Medicines Agency (EMEA), its facility in Kuopio, Finlandhas received Good Manufacturing Practice (GMP) Certification to manufacturecommercial supplies of its adenoviral-based gene medicine CereproTM, a genebased medicine for the treatment of brain cancer. Ark's facility, in Kuopio, Finland is believed to be the only facility outsideof China to have been licensed to manufacture gene based medicines forcommercial supply. Nigel Parker, CEO of Ark, commented: "This is a tremendous achievement by theCompany. A number of years of meticulous planning and work have gone intoachieving this certification and it endorses our leadership position in thisupcoming area of molecular medicine." For further information, please contact: Ark Therapeutics Group plc 020 7388 7722 Dr Nigel Parker, CEO Financial Dynamics 020 7831 3113 David Yates Davina Langdale Ark Therapeutics Group plc Ark is a specialist healthcare group (the "Group") with one marketed product andthree further lead products in late stage clinical development. Capitalising onover ten years of research in vascular biology and gene-based medicine, Ark hasa balanced product portfolio targeted at specific unmet clinical needs withinvascular disease and cancer. These are large and growing markets, whereopportunities exist for effective new products to generate significant revenues. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable them to be taken throughdevelopment within the Company'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 continue to play leading roles in the Company's researchand development programmes. 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