PVG.L Regulatory News (PVG)

7 Jun 2007 07:00

Ark Therapeutics Group PLC07 June 2007 Ark strengthens wound care portfolio with third product Kerraped(R) Pricing agreed with NHS Business Services Authority with UK launch scheduled for Q3 London, UK, 7 June 2007 - Ark Therapeutics Group plc ("Ark") today announcesthat its subsidiary, Patient Plus Limited, has signed an exclusive licensingagreement with Darco GmbH & Co., a manufacturer of surgical, trauma and woundcare products, in respect of the UK and international marketing rights for aDarco proprietary medical footwear device for the management of diabetic footulcer patients. The device will be marketed by Ark under the Ark brand ofKerraped(R). Ark also announces today that it has successfully achieved pricingre-imbursement from the UK NHS Business Services Authority for Kerraped(R),making it the first product of its class to be available to the NHS onprescription. Under the terms of the licensing agreement, Darco will manufacture and supplythe product at an agreed transfer price to Ark, who will be responsible forreimbursement and conducting all sales and marketing activities. Ark willlaunch an all purpose boot (APB) and a more lightweight shoe version of Kerraped(R) after their listing in the Drug Tariff Guide in a new category to be called'Plantar Pressure Offloading Devices', currently expected in August, at a priceof £16.63 and £12.57 respectively. Ark's existing UK sales force, which currently markets Kerraboot(R), a novelmicroclimate dressing device for diabetic and venous leg ulcers, and Flaminal(R), an antimicrobial gel for infected wounds, will be used to promote Kerraped(R). The two Kerraped(R) variants will have wide utility being suitable for allpatients who need to reduce plantar pressure (pressure on vulnerable areas ofthe sole of the foot). Kerraped(R) can be used with Ark's Kerraboot(R) and willimprove patients' mobility as well as providing further protection to the wound. Ark's existing international Kerraboot(R) licensees will be offered the localdistribution rights to Kerraped(R) where appropriate. A recent audit of Primary Care Trusts in the UK1 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 to30%2 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. Kerraped(R)'s inclusion in the Drug Tariff as the first in a new class is drivenby its potential to offer significant cost savings to the NHS. With diabeticfoot ulcers alone, the cost of treatment to the NHS is currently estimated ataround £500m per annum. Net cost savings to the NHS of up to £90 million couldbe possible, as clinical data so far has shown that medical footwear providingproper offloading characteristics can keep diabetic patients' feet ulcer-freefor up to three times longer and reduce relapse rates overall by 50%3. Nigel Parker, CEO of Ark, commented: "Such specialist footwear has historically only been available in hospitalswhere its biomechanical characteristics have been well recognised by specialistsas providing benefits to healing ulcers and preventing recurrence. As thenumber of patients with diabetes increases, the NHS is coming under mountingpressure to offer an effective treatment to patients beyond the hospitalsetting. Kerraped(R) will be available now to the whole community and will giveall patients the mechanical offloading they need at a very cost effective price. This agreement with Darco represents another development in our long-termstrategy of building a stand-alone wound care and devices division and allows usto leverage our UK sales infrastructure for Kerraboot(R) and Flaminal(R)." References: (1) King B et al "An Audit of Footwear for Patients with Leg Bandages" NursTimes; 103(9): 40,42-3 (2) Glod DJ, Gibbons RW. "A comparison of weight bearing pressures in variouspostoperative devices. The Journal of Foot and Ankle Surgery." Vol 35;2: 1996 (3) Uccioli L "Manufactured shoes in the prevention of diabetic ulcers" DiabetesCare, 18; 10, 1995 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 YatesAnna Keeble Notes to Editors The Diabetic Foot Ulcer market The prevalence of diabetes in the UK is 4.2% of the total population. 15% ofthese patients will suffer from an ulcer at some point during their lives andaround 5% of all diabetics will have a foot ulcer in a 12 month period4. TheseUK statistics indicate that there will be around 123,000 diabetic foot ulcers inany 12 month period. Around half of these will be in need of treatment at anyone time. About 50% of patients undergoing non-traumatic amputation have adiabetic foot ulcer. These patients have a high mortality following amputation,ranging from 39% to 80% over 5 years5. Whilst data vary across the world thesedata are generally representative of the global situation. References: (4) NICE (2004) "Type 2 diabetes: Prevention and Management of Foot Problems"Clinical Guidelines 2004 (5) Moulik KP "Amputation and mortality in new-onset diabetes foot ulcersstratified by etiology" Diabetic Care, 26: 491-494, 2003 Darco Darco is an international group of companies with operations in the USA, Europeand China. They specialise in innovative solutions for foot surgery, such asimplants and instruments, but also post-operation shoes and pressure-reliefshoes. 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 two marketeddevices, Kerraboot(R), and Flaminal(R), and three further lead pharmaceuticalproducts in late stage clinical development: Cerepro(R), Vitor(R), and Trinam(R), the Group is transitioning from an R&D company to a commercial, revenuegenerating business. Ark's existing 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 statement. This information is provided by RNS The company news service from the London Stock Exchange