PVG.L Regulatory News (PVG)

15 Feb 2006 07:01

Ark Therapeutics Group PLC15 February 2006 Ark signs marketing deal with Sino Tau for Kerraboot(R) in China 15 February 2006, London UK: Ark Therapeutics Group plc today announces that ithas signed an exclusive licensing agreement granting Sino Tau InternationalCompany Limited (Sino Tau), a Chinese healthcare company, the sales andmarketing rights to Kerraboot(R) for the Chinese market. Kerraboot(R) is Ark'snovel wound care device for the management of leg and foot ulcers. Sino Tau,based in Beijing, is an established distributor of both pharmaceuticals andmedical devices in China and markets products through its own sales andsub-distributor network. Under the terms of the licence, Sino Tau will be responsible for all theprocesses necessary to market Kerraboot(R), including obtaining the necessaryGovernment and regional approvals. Ark will supply the product to Sino Tau atan agreed transfer price. Other financial terms of the transaction were notdisclosed. China has a population of 1.3 billion and lower leg and foot ulceration affectsaround 2% of the adult population. At present, approximately 40% of the Chinesepopulation is able to afford western healthcare products and these people arelocated in the main urban areas. The market potential for Kerraboot(R) inChina is very large and it will initially be marketed for the growing problem ofdiabetic ulcers and those venous ulcer patients who are intolerant of currenttreatments, giving an estimated initial target group of 160,000 patients(1). Theprevalence of diabetes in China is approximately three times higher than 10years ago and China now ranks second, behind India, as the country with thehighest prevalence, with an estimated 24 million diabetic population1.Diabetics are 25 times more likely to lose a leg by amputation than nondiabetics and it is estimated that 50,000 diabetes-related lower extremityamputations are performed each year in China, of which 85% are preceded by afoot ulcer(2). Kerraboot(R) provides a new approach to the management of these ulcers, in theform of a novel, non pressurized, boot-like dressing device, which is simple,quick and pain free to change. Kerraboot(R) facilitates the draining andisolation of wound exudates such as matrix metalloproteases (which inhibitangiogenesis) from the ulcer. This allows natural growth factors, such asVascular Endothelial Growth Factors (VEGF), to stimulate healing. In clinicalstudies of ulcers managed with Kerraboot(R), reductions in ulcer sizes of up to60% were observed over the four-week study period, with both healthcareprofessionals and patients expressing a strong preference for Kerraboot(R) overcurrent standard treatments. UK-based studies have also shown that management ofulcers with Kerraboot(R), which does not involve any additional dressings, canbe extremely cost effective saving up to 50% of nurse time and with patientsoften becoming nurse independent. Late last year Ark launched a new and moreversatile extra-absorbent version of the device to extend both the range ofulcers that can be treated and the length of treatment for more exudativewounds. Launched in response to market demand, the new version has had a veryfavourable reception from nurses and other healthcare professionals. Ark willbe supplying the extra absorbent version to its international licensees. Nigel Parker, CEO of Ark, commented: "The flow of independent case historiesillustrating the effectiveness of Kerraboot(R) in managing leg ulcers has beenof increasing interest to potential partners. This licensing deal with Sino Tauopens up a very substantial market in which Kerraboot(R) can make a significantimpact on those suffering from these serious conditions. We continue to discusslicensing arrangements with other international partners to bring the benefitsof Kerraboot(R) to the greatest possible number of patients." For further information please contact: Ark Therapeutics +44 (0)20 7388 7722Dr Nigel Parker, Chief ExecutiveMartyn Williams, Chief Financial Officer Financial Dynamics +44 (0)20 7831 3113David Yates / Davina Langdale 1. World Health Organisation data (www.who.org) 2. Figures estimated by Ark by combination of data contained in (i) Boulton, AJ et al (2005) The Global burden of diabetic foot disease Lancet, Nov 12;366(9498):1719-24, (ii) International Diabetes Federation - Position Statement, The Diabetic Foot: amputations are preventable, May 2005 and (iii) World Health Organisation data (www.who.org). Notes to Editors Ark Therapeutics Group plc Ark is an emerging healthcare group (the "Group") now entering thecommercialisation phase, with one product introduced into hospitals and threefurther lead products in late stage clinical development. Capitalising on overten years of research in vascular biology and gene-based medicine, Ark has abalanced portfolio of proprietary healthcare products targeted at specific unmetclinical needs within vascular disease and cancer. These are large and growingmarkets, where opportunities exist for effective new products to generatesignificant revenues. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable Ark to take each productthrough development and to benefit from Orphan Drug Status and/or Fast TrackDesignation, as appropriate. The Group generally retains ownership of itsproduct candidates throughout clinical development. Ark has secured patents orhas patent applications pending for all its lead products in principalpharmaceutical markets and retains the right to market its lead products in thekey North American and European markets. 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). Sino Tau International Company Limited Part of an established healthcare group, Sino Tau Intl. has diversified businessperformance in both medical device and pharmaceutical fields with expertisecovering regulatory, marketing and sales, OEM and contract research. Withparticular expertise in oncology, organ transplantation, diabetic,interventional therapy, liver disease and neurology, Sino Tau are exclusivelyrepresenting a number of novel high-tech medical products in China. 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