PVG.L Regulatory News (PVG)

23 Mar 2005 07:00

Ark Therapeutics Group PLC23 March 2005 Ark Therapeutics Group plc Regulatory Update on Cerepro(TM) and Vitor(TM) 23 March 2005: Ark Therapeutics Group plc ("Ark" or the "Company") todayannounces regulatory progress for its two lead products, Cerepro(TM) and Vitor(TM). EMEA appoints Rapporteurs for Cerepro(TM) Ark announces that as part of ongoing discussions with the EMEA concerning itsproduct Cerepro(TM), a novel therapy for operable malignant glioma, the EMEA hasformally appointed a Rapporteur and Co-Rapporteur for the product. The role ofthe Rapporteurs is to manage the application for marketing authorisation, whichArk intends to file under the exceptional circumstances provisions, through thecentralised regulatory process. Ark further announces that it has now met withboth the Rapporteur and the Co-Rapporteur together with their countryrepresentatives and both have indicated their willingness to perform thisfunction. Ark has performed three clinical studies to date with Cerepro(TM), a Phase I study establishing safety and posology (dosing and method of administration) and two safety and efficacy studies, both showing Cerepro(TM) produced an averageextension of 7 months' survival in a disease where most patients will live foraround eight months. Cerepro(TM) has Orphan Drug Status in Europe and the USA and is manufactured by Ark in Finland. Dr Alan Boyd, Director of Research & Development at Ark, said, "We are pleasedto have cleared this next step with the EMEA. The results observed in thetrials for Cerepro(TM) to date represent a large clinical benefit to patients inthis devastating disease where new effective treatments are urgently needed. Weare now continuing with the development and manufacturing work necessary forfiling." Vitor(TM) submission via Decentralised Procedure advised as appropriate regulatory route Ark also announces that it has attended a pre-submission meeting with theMedicines and Healthcare products Regulatory Agency (MHRA) to discuss theregulatory position for Vitor(TM). The Agency advised during the meeting thatshould the Phase III study results in cancer cachexia, due in H2 2005, showrelevant and significant clinical benefits in the treatment's favour, with anacceptable safety profile, then submission via the new decentralised procedure,which comes into effect later this year, would be appropriate. Vitor(TM) is a small molecule in Phase III development in the USA, Canada andEurope. Ark expects to complete enrolment in the study in the next few weeks,giving a target date for initial results to be available of Q3 2005. Vitor(TM)works by enhancing mitochondrial activity and both reducing protein breakdownand enhancing protein synthesis in muscle cells via the ubiquitin-proteasomepathway. Dr Alan Boyd, Director of Research and Development at Ark, said: "Given thestatus of the Phase III trial with Vitor(TM), now was the appropriate time tostart discussions with the Regulatory Authorities. We are pleased to haveestablished the appropriate regulatory pathway for the product and that theroute is in line with our internal plans." For further information: Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722Dr Nigel Parker, CEODr Alan Boyd, R&D Director Financial Dynamics Tel: +44 (0)20 7831 3113David YatesLucy Briggs Notes to Editors 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, prospective investors arecautioned not to rely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange