PVG.L Regulatory News (PVG)

10 Oct 2006 07:01

Ark Therapeutics Group PLC10 October 2006 Ark Therapeutics Group plc Ark Announces Kerraboot(R) Entry into US Market 10 October 2006, London UK: Ark Therapeutics Group plc ("Ark" or the "Company")today announces that its devices subsidiary, Patient Plus Limited, has signed apilot distribution and marketing agreement with the US medical productsdistributor, Health Care Logistics Inc. ("HCL") for Kerraboot(R), Ark's novelwound care device for the management of leg and foot ulcers. This exclusive agreement, initially for one year, will establish first sales ofKerraboot(R) in the US and will allow Ark to obtain data supporting the healtheconomic benefits of Kerraboot(R) for this market. In Europe, it has beendemonstrated that the use of Kerraboot(R) in patients with diabetic leg and footulcers can result in a reduction in total healthcare costs of up to 48%(1). Under this pilot agreement, HCL will access its established healthcare customersin the Eastern US Seaboard States(2), including hospitals, nursing homes, longterm care centres and home health agencies. Ark will supply Kerraboot(R) at anagreed "cost-plus" transfer price to HCL and will also provide corporate productsupport and assistance in establishing usage with certain key US opinion leaderswho have expressed an interest in the product. Sales through this arrangementare expected to make a positive financial contribution to Ark during the initialperiod. Kerraboot(R) is already listed by the FDA for marketing and the USpatent for the product was granted to Ark earlier this year. Lower leg and foot ulceration affects around 1% of the adult population in thedeveloped world(3) and is particularly prevalent amongst the diabeticpopulation, where the ulcers can develop rapidly and are particularly difficultto heal. The US is estimated to have a potential target market of 270,000 legand foot ulcer patients suitable for Kerraboot(R) at any one time(4). Paul Higham, Commercial Director at Ark, commented: "We are very pleased to announce this agreement with HCL. We believe they offerthe right capabilities to facilitate the entry of Kerraboot(R) into the USmarket and allow us to start building a data package which will demonstrate boththe economic advantages of the product to US payers and confirm its clinicalbenefits to patients. We look forward to working together with them". For further information please contact: Ark Therapeutics +44 (0)20 7388 7722Dr Nigel Parker, Chief Executive OfficerMartyn Williams, Chief Financial Officer Financial Dynamics +44 (0)20 7831 3113David Yates / Anna Keeble Notes to Editors Sources: (1) Company cost utility model based on published data. (2) Connecticut, Delaware, Rhode Island, Massachusetts, Maine, New York, New Jersey, Maryland, Ohio, Virginia, West Virginia, Vermont, New Hampshire and Pennsylvania. (3) Briggs M, Nelson EA: Topical agents or dressings for pain in venous leg ulcers; The Cochrane Library, Issue 1, 2002 (4) Company estimates based on patient populations and composite references. 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 studies of ulcers managed with Kerraboot(R), reductions in ulcer sizeof up to 60% has 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. Health Care Logistics, Inc. HCL is a privately owned US Corporation, established in 1978, engaged in thesales and marketing of niche healthcare products and with annual revenues of $48million. HCL has 19,000 customers and covers 98% of all US hospitals. 60% ofHCL's revenue sales are from hospitals, followed by drug stores and nursinghomes. The Company has a 60,000 sq ft headquarter facility in Circleville,Ohio, a 110,000 sq ft Distribution & Logistics Centre in Grove City, Ohio and a40,000 sq ft Sales and Service centre in Galloway, Ohio. The Company has 175employees of which 60 are sales and service representatives. Ark Therapeutics Group plc and Patient Plus Ltd. Patient Plus Ltd is a wholly owned subsidiary of Ark Therapeutics Group plc, aspecialist healthcare group (the "Group") addressing high value areas of unmetmedical need within vascular disease, wound care and cancer. These are largeand growing markets, where opportunities exist for effective new products togenerate significant revenues. With two marketed devices, Kerraboot(R) andFlaminal(R), and three further lead pharmaceutical products in late stageclinical development: CereproTM, VitorTM, and Trinam(R), the Group istransitioning from an R&D company to a commercial, 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 statement. This information is provided by RNS The company news service from the London Stock Exchange