PVG.L Regulatory News (PVG)

30 Mar 2006 07:01

Ark Therapeutics Group PLC30 March 2006 Ark Broadens International Reach for Kerraboot(R) with Three Further Marketing Deals Number of Deals in 2006 Rises to Six 30 March 2006, London UK: Ark Therapeutics Group plc today announces that it hassigned three further international marketing agreements for Kerraboot(R), Ark'snovel wound care device for the management of leg and foot ulcers, bringing thetotal number of deals signed this year to six. Exclusive distribution rightshave been signed with MediGroup Australia Pty Ltd for Australia, New Zealand andthe Pacific Islands, with KYO Kronik Yara Organizasyonu Ltd.STI (Chronic WoundOrganization Ltd) for Turkey and with Gulf Business Development Co W.L.L. forKuwait, with an option for the Gulf States and Middle East. Under the various terms of the agreements, Ark will supply Kerraboot(R) at anagreed transfer price and will also receive sales-related milestones in returnfor the marketing rights to Kerraboot(R). All the licensees will be responsiblefor marketing to all sectors of the healthcare community in their respectiveterritories, as well as completing the appropriate regulatory and reimbursementprocesses. With the out-licensing deals announced earlier in the year for China, Denmarkand The Netherlands/Luxembourg, the number of international Kerraboot(R) dealshas now risen to nine overall1. Ark expects to commence international sales inthe first half of 2006. Lower leg and foot ulceration affects around 1% of the adult population in thedeveloped world2 and is particularly prevalent amongst the diabetic populationwhere the ulcers can develop rapidly and are particularly difficult to heal.Whilst national statistics for the incidence of diabetes and leg ulcers varyfrom country to country, these deals are projected to access a combined targetmarket of 144,000 patients3 who have a leg or foot ulcer at any one time. Kerraboot(R) provides a new approach to the management of these ulcers, in theform of a novel, non pressurised, boot-like dressing device, which is simple,quick and pain free to change. Kerraboot(R) facilitates the draining andisolation of 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% have been observed over the four-week study period, with both healthcareprofessionals and patients expressing a strong preference for Kerraboot(R) overexisting treatments. These 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 more versatile extra-absorbent version ofthe device to extend both the range of ulcers that can be treated and the timebetween dressing device change for more exudative wounds. Launched in responseto market demand, the new version has had a very favourable reception fromnurses and other healthcare professionals with comparative period UK salesshowing 48% year on year growth. All international licensees will market thenew super-absorbent boot in both the existing transparent and opaque versions,the latter being due to complete initial production at the end of April. Mr Paul Higham, Commercial Director of Ark, commented: "These latest dealsdemonstrate the success we are having in our international roll-out of Kerraboot(R). Through these agreements we are rapidly building up access to anincreasing number of patients who should benefit from Kerraboot(R). We lookforward to the commencement of international sales as the new Kerraboot(R)versions become available." 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 Israel; Ireland; South Korea; China; Denmark; The Netherlands and Luxembourg; Australia, New Zealand and Pacific Islands; Turkey; and Kuwait2 Briggs M, Nelson EA: Topical agents or dressings for pain in venous leg ulcers; The Cochrane Library, Issue 1, 20023 Company estimates based on patient populations Ark Therapeutics Group plc Ark is an emerging healthcare group (the "Group") with one marketed product andthree further lead products in late stage clinical development. Capitalising onover ten years of research in vascular biology and gene-based medicine, Ark hasa balanced product portfolio targeted at specific unmet clinical needs withinvascular disease and cancer. These are large and growing markets, whereopportunities exist for effective new products to generate significant revenues.Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable them to be taken throughdevelopment within the Company'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 byProfessor John Martin and Mr Stephen Barker of University College London andProfessor Seppo Yla-Herttuala of the AI Virtanen Institute at the Universityof Kuopio, Finland, all of whom continue to play leading roles in the Company'sresearch and development programmes. MediGroup Australia Pty Ltd: Australia, New Zealand and Pacific Islands MediGroup is concerned with medical product research and marketing of medicaldevice products in Australia, New Zealand and the Pacific Islands. The companyis privately owned. Australia has a diabetic population of approximately 760,000 people (AustralianBureau of statistics, April 22 2005 Projection) or 3.8% of the generalpopulation and an incidence of neuropathic ulcers of 1.5% (Diabetes Care 22:382-387, 1999 "Incidence Outcomes and Costs of Foot Ulcers in Patients withDiabetes"). Based on these figures, the market potential for Kerraboot(R)targeted at the diabetic and venous ulcer market is estimated by Ark to be24,000 patients. KYO Kronik Yara Organizasyonu Ltd.STI (Chronic Wound Organization Ltd): Turkey KYO is wholly focussed on the Turkish chronic wound care market. The company isthe exclusive distributor for KCI and ConvaTec Wound Therapeutics and foradditional smaller companies focussed on the wound care business (TavTech andMaxis). KYO has an extensive distribution network throughout Turkey andservices hospitals and patient sectors. Turkey has a diabetic population of approximately 5.5 million people (PopulationBased Study of Diabetes and Risk Characteristics in Turkey Diabetes care 25:1551-1556, 2003) or 7.2% of the general population and an incidence ofneuropathic ulcers of between 2%-3.5% (Yavuzer, Dr C.Reha: Plastic andReconstructive Surgery Vol 105(7) June 2000). Based on these figures, themarket potential for Kerraboot(R) targeted at the diabetic and venous ulcermarket is estimated by Ark to be 105,000 patients. Gulf Business Development Co W.L.L.: Kuwait GBD is a privately-owned Kuwaiti company which provides healthcare productsprincipally to the Ministry of Health, Ministry of Defense, Kuwait Oil Company,Kuwait National Petroleum Co. Kuwait Institute of Scientific Research, privatehospitals and healthcare clinics. Kuwait has a high diabetic population of approximately 175,000 people (Knowntype 2 diabetes mellitus among the Kuwaiti population N.Abdella, M.Khogali ActaDiabetol33 (145-149) 1996) representing approximately 7.5% of the generalpopulation and an incidence of neuropathic ulcers of up to 8%. Based on thesefigures, the market potential for Kerraboot(R) targeted at the diabetic andvenous ulcer market is estimated by Ark to be 15,000 patients. 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