PVG.L Regulatory News (PVG)

17 Apr 2008 07:00

Ark Therapeutics Group PLC17 April 2008 Ark Therapeutics Group plc Ark products win inclusion on new NHS Advanced Woundcare Therapies Contract London, UK, 17 April 2008 - Ark Therapeutics Group plc ("Ark" or the "Company")today announces that it has received notification that all three of its productscurrently marketed to the primary care sector in the UK, Kerraboot(R), Flaminal(R) and Kerraped(R), have been accepted for inclusion on the new NHS SupplyChain Advanced Woundcare and Topical Negative Pressure Therapy Contract. This new procurement process, designed to rationalise prescribing and "promotebest practice and cost-effective innovation in woundcare", is a nationalinitiative supported by almost all procurement hubs (new regionalised NHSpurchasing groups), whereby all NHS Trusts in England and Wales will beencouraged to use and purchase their supplies from this contract formulary,effective 1 May 2008. In order to achieve acceptance onto the procurement contract, products have topass a range of new NHS defined standards of clinical and cost effectiveness.Product assessments are carried out by a task force of independent expertsappointed by the NHS who rigorously evaluate the clinical need and quality ofevidence supporting each product. Products on the new formulary will be actively promoted by the NHS supply chainvia its catalogue to all NHS and Primary Care Trusts. Products not acceptedwill not be carried as stock by the NHS supply chain. Ian Shurville, Head of Woundcare at Ark UK, commented: "We are delighted thatour full range of woundcare products has been accepted onto this important newNHS procurement contract. Ark's products have consistently demonstratedsignificant efficacy in unmet clinical need and at the UK reimbursed price theiruse consistently shows a clear cost benefit to the NHS." Dr Nigel Parker, CEO of Ark, commented: "Ark is steadily assembling a portfolioof effective patented wound care products for the UK market. This important NHScontract success demonstrates that our products stand up to the latest rigoroushealth economic assessment and that they provide clear benefits to both patientsand healthcare payers. As this new NHS contract becomes implemented we expectour products to benefit significantly from their inclusion." For further information: Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722Dr Nigel Parker, CEOMartyn Williams, CFO Financial Dynamics Tel: +44 (0)20 7831 3113David YatesSusan Quigley Notes to Editors Kerraboot(R) Kerraboot(R) provides a new approach to the management of foot and leg ulcers,in the form of a novel, non pressurised, boot-like dressing device, which issimple, quick and mostly pain free to change. Kerraboot(R) facilitates thedraining and isolation of exudates, such as matrix metalloproteases, whichinhibit angiogenesis, from the ulcer. This allows natural growth factors, suchas Vascular Endothelial Growth Factors (VEGF), to stimulate healing. Inclinical studies1 of ulcers managed with Kerraboot(R), reductions in ulcer sizeof up to 60% have been observed over the four-week study period, with bothhealthcare professionals and patients expressing a strong preference forKerraboot(R) over existing treatments. These UK-based studies have also shownthat management of ulcers with Kerraboot(R), which does not involve anyadditional dressings, can be extremely cost effective, saving up to 50% of nursetime and with patients often becoming nurse independent. Flaminal (R) and Flaminal(R) Hydro Flaminal(R) and Flaminal(R) Hydro contain proprietary biological anti-microbialenzyme systems providing protection from infections without toxicity to humancells2. They maintain the wound in a humid environment, continuously debridethe wound, restore bacterial balance and are both non-cytotoxic andhypoallergenic. Flaminal(R) is indicated for the following wounds: Highly exuding ulcers, oncologic wounds, second degree burns, post-operativewounds, pre-operative fibrinous wounds and bed sores. Flaminal(R) Hydro is indicated for the following wounds: Dermatosurgery, moderately exuding ulcers, second degree burns andpost-operative, moderately exuding wounds. Flaminal(R) and Flaminal(R) Hydro are CE-marked within the EU and approved forsale in China, Switzerland and Saudi Arabia. Kerraped(R) Diabetes remains a major health problem in the UK, with the prevalenceincreasing by 1.77m to 1.89m in 12 months (2005-2006)2. 5% of this populationwill have a foot ulcer in any one year4, equating to 132,000 people, and 15% ofdiabetics will have a foot ulcer in their life time.5 A recent audit of Primary Care Trusts in the UK6 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%7,8 and does not need to be customised to achieve this pressure reduction.Unlike other products, Kerraped(R) can be prescribed by primary healthcareprofessionals without additional training and product customisation. A recent study9 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. Leigh R, Barker S, Murray N, Hurel SJ. The Kerraboot(R): A novel wounddressing device for the management of leg and foot ulcers. Practical DiabetesInt 2004;21(1):27-30 2. D Van den Plas et al., Flaminal(R) Hydro combines non-cytotoxicity withantimicrobial activity, Wounds UK 2005. 3. 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 4. NICE (2004) Type 2 diabetes: prevention and management of foot problems.Clinical Guideline 2004 5. American diabetes Association. Consensus Development Conference on DiabeticFoot Wound Care; Diabetes care, vol. 22,8,August 1999 6. King, B.K. An audit of footwear for patients with leg bandages. NursingTimes, Feb 2007. Vol 103: No. 9 7. 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 8. Gibbons RW et al. A Comparison of Weightbearing Pressures in VariousPostoperative Devices. Journal of Foot and Ankle Surgery Vol 35,2:1996 9. Leigh, R. A Prospective Study to Determine the Effect of AppropriateFootwear in Improving Quality of Life in Ulcer Patients. Data on file. 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