PVG.L Regulatory News (PVG)

11 Mar 2008 07:01

Ark Therapeutics Group PLC11 March 2008 Ark Announces UK Launch of Neuropad(R) for Diabetic Patients London, UK, 11 March 2008 - Ark Therapeutics Group plc ("Ark" or the "Company")today announces the launch in the UK of Neuropad(R), an innovative diagnostictest to detect peripheral autonomic neuropathy in the feet of diabetic patients. Neuropad(R) will initially be made available via podiatrists. Once Drug Tariff(DT) listing has been achieved, Ark will promote Neuropad(R) in primary carethrough its existing UK salesforce which currently markets the Company's otherwound care products, Kerraboot(R), Kerraped(R) and Flaminal(R). The applicationfor DT listing has already been submitted to UK NHS Business Service Authority. Neuropad(R) is an easy to use, objective screening test for peripheral autonomicneuropathy and an early detection test for diabetic foot syndrome. The lattermost frequently results in open foot ulcers which are both distressing for thepatient and difficult to treat. Neuropad(R) assesses the status of the sweatgland (sudomotor) response by measuring the moisture status of the foot. Anabnormal sweat gland response is closely correlated with the onset of peripheralautonomic neuropathy in the feet. Current screening tools for the early detection of the diabetic foot syndrome inprimary care are subjective and rely on the skill of healthcare professionals.However, autonomic neuropathy affects small fibres much earlier in the diseaseprocess (in most cases) and Neuropad(R), unlike the currently available tests inprimary care, will detect this damage when patients are asymptomatic of largefibre damage. Neuropad(R), which Ark has in-licensed from the German woundcare company, MiroVerbandstoffe GmbH, has been designed to be safe, non-invasive and easilyapplied in a primary care setting, including long term residential or nursingcare, and can be applied without additional training by practice nurses andcommunity podiatrists as they perform routine screening of their diabeticpatients. Neuropad(R) supports the NHS Quality Outcomes Framework whichrecommends that all diabetic patients are assessed for peripheral neuropathyevery 12 months. Early identification of neuropathy using Neuropad(R) will reduce the incidenceof diabetic foot ulcers by allowing timely preventative measures to beimplemented. The cost to the NHS of treating a foot ulcer is estimated to be£5,200 and as many as 64,000 diabetic patients are likely to develop an openulcer in any one year1. Commenting on today's announcement, Paul Higham, Ark's Commercial Director,said: "Neuropad(R) is a highly innovative product which we can now offer to healthcareprofessionals in the UK to improve their management of diabetic patients. SinceNeuropad(R) is very sensitive and able to detect early neuropathy, we believe itwill have a significant impact on the rate of diagnosis of neuropathy, reducingboth the clinical and cost burden of diabetes to the NHS. "Neuropad(R) is an ideal fit with Ark's wound care strategy of introducinginnovative products that deliver both clinical benefits and savings to thehealthcare system. It is another development in our long-term objective ofbuilding a stand-alone wound care business in the UK, which we will continue tostrengthen through further in-licensing and the development of our ownproducts." References 1 Posnet J, Franks P J. The burden of chronic wounds in the UK. 2008. NursingTimes. 104:3. 44 - 45. 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 / Susan 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 four marketeddevices, Kerraboot(R), Kerraped(R), Flaminal(R) and Neuropad(R), and threefurther lead 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