PVG.L Regulatory News (PVG)

20 Aug 2007 07:02

Ark Therapeutics Group PLC20 August 2007 Ark Launches Kerraped(R) - the First Therapeutic Footwear Available on Prescription London, UK, 20 August 2007: Ark Therapeutics Group plc ("Ark" or "the Company")today announces the launch of Kerraped(R), the first therapeutic footwear to bemade available on prescription, for patients with diabetic foot ulcers and otherlower limb wounds. The licensing of this product was announced by the Company on7 June 2007 and it has now been placed on the UK NHS Drug Tariff. Kerraped(R) All Purpose Boot (APB) is available on prescription from today tohelp alleviate the suffering of patients with diabetic foot ulcers. Until now,patients in the community have often not had access to suitable medical footwearas it has only been provided via secondary care, for example in diabetic foot,podiatry, and orthotic clinics. Kerraped(R) will be sold by Ark's existing woundcare sales force alongside Kerraboot(R) and Flaminal(R), where it iscomplementary to both products and full promotion will commence on 1 September. Kerraped(R) APB has been specially designed to be worn by patients with diabeticfoot ulcers. It is easy to fasten and provides the appropriate level ofoff-loading and foot support without interfering with the patient's normalwalking gait. In tests, Kerraped(R) has demonstrated a 25% reduction in pressureon the foot surface while walking. A reduction in foot pressure, especially inat-risk areas of the foot, is essential to allow ulcers to heal and preventrecurrence. Kerraped(R) is available in 4 sizes: small, medium, large andextra-large. Whilst no market data currently exists for this new class of product, theCompany estimates the total potential market opportunity in the UK to be between200,000 and 250,000 units per annum. Ian Shurville, Head of Wound Care at Ark, commented: "We are very pleased to addKerraped(R) to our expanding wound care portfolio. We believe that suitablefootwear is a key component of wound management for many patients with diabeticfoot ulcers and we are confident that Kerraped(R) will make a significantdifference to community-based patients previously without access to specialisedfootwear." - Ends - For further information, please contact: Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722Dr Nigel Parker, CEOMartyn Williams, CFO Financial Dynamics Tel: +44 (0)20 7831 3113David Yates Notes to Editors: Diabetes remains a major health problem in the UK, with the prevalenceincreasing by 1.77m to 1.89m in 12 months (2005-2006)(1). 5% of this populationwill have a foot ulcer in any one year(2), equating to 132,000 people, and 15%of diabetics will have a foot ulcer in their life time.(3) A recent audit of Primary Care Trusts in the UK(4) has shown that the absence ofthe availability of properly designed medical footwear in the community resultsin 66% of patients wearing footwear which is inappropriate for their condition.This results in a significantly higher rate of foot ulcer recurrence,particularly in the diabetic community, as well as a significantly increasednumber of falls. Kerraped(R) has been shown to reduce plantar pressure by up to25%(5),(6) and does not need to be customised to achieve this pressurereduction. Unlike other products, Kerraped(R) can be prescribed by primaryhealthcare professionals without additional training and product customisation. A recent study(7) showed that enabling primary care professionals to accessKerraped(R) resulted in an improvement in the health related quality of life(HRQoL) for patients with lower limb and foot ulcers, as well as other lowerlimb disorders requiring bulky bandages and dressings. Patients who switched toKerraped(R) APB for two weeks, having previously sourced and adapted their ownfootwear, showed up to 10.7% and 11.1% improvements respectively in the two keyHRQoL domains of physical function/everyday living and well being. Improvementsto both of these scores are reflective of the positive clinical advantagesspecialist medical footwear like Kerraped(R) provides. References: 1. National Quality and Outcomes Framework; Statistics for England 2005/06.Published by The Information Centre; Part of the Government StatisticalService; ISBN: 1-84636-078-1 2. NICE (2004) Type 2 diabetes: prevention and management of footproblems. Clinical Guideline 2004 3. American diabetes Association. Consensus Development Conference onDiabetic Foot Wound Care; Diabetes care, vol. 22,8,August 1999 4. King, B.K. An audit of footwear for patients with leg bandages.Nursing Times, Feb 2007. Vol 103: No. 9 5. Lavery LA et al. A Qunantitative Assessment of Healing Sandals andpostoperative Shoes in Offloading the Neuropathic Diabetic Foot. Journal ofFoot and Ankle Surgery. Vol. 36,1:1997 6. Gibbons RW et al. A Comparison of Weightbearing Pressures in VariousPostoperative Devices. Journal of Foot and Ankle Surgery Vol 35,2:1996 7. 7. Leigh, R. A Prospective Study to Determine the Effect ofAppropriate Footwear in Improving Quality of Life in Ulcer Patients. Data onfile. 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 three marketeddevices, Kerraboot(R), Kerraped(R) and Flaminal(R), and three further leadpharmaceutical products in late stage clinical development: Cerepro(R),Vitor(TM), 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 anddevelopment 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 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 statements. This information is provided by RNS The company news service from the London Stock Exchange