PVG.L Regulatory News (PVG)

12 Jan 2006 07:00

Ark Therapeutics Group PLC12 January 2006 Ark Receives US Patent for Kerraboot(R) 12 January 2006, London UK: Ark Therapeutics Group plc today announces the grantof its patent in the US, Patent Number 6982358, for Kerraboot(R), a novelwoundcare device for the management of leg and foot ulcers. Kerraboot(R) hasalready been listed for marketing by the Food and Drug Administration in the US. Kerraboot(R) is currently marketed by Ark in the UK with increasing clinicalsuccess reported amongst nursing and hospital communities. Late last year Arklaunched a new and more versatile extra-absorbent version of the device toextend both the range of ulcers that can be treated and the length of treatmentfor more exudative wounds. Launched in response to market demand, the newversion has had a very favourable reception from nurses and other healthcareproviders. The Company also intends to release an opaque version in early 2006for those patients who do not want their wounds to be visible. The Company hassigned distribution agreements for Israel, Ireland and South Korea, and furthersuch agreements and the commencement of international sales are expected during2006. Lower leg and foot ulceration affects around 1% of the adult population in thedeveloped world1 and is particularly prevalent amongst the diabetic population,in which the ulcers can develop rapidly, are particularly difficult to heal andcan sometimes lead to amputation. 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 less painful 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) 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. Nigel Parker, Chief Executive of Ark, commented: "The US patent has been a whilecoming and its grant will now enable us to progress our commercialisationstrategy for Kerraboot(R) in the US market. We are increasingly encouraged bythe number of independent case reports being published demonstrating theeffectiveness of Kerraboot(R) and by the response to the new version. We arealso now seeing Kerraboot(R) being taken up by increasing numbers of primarycare trust formularies in the UK. We believe that there is a significantopportunity for Kerraboot(R) in the US market and we look forward to updatingshareholders regarding our UK and international progress in the coming months." For further information please contact: Ark Therapeutics +44 (0)20 7388 7722 Dr Nigel Parker, Chief Executive Martyn Williams, Chief Financial Officer Financial Dynamics +44 (0)20 7831 3113 David Yates / Davina Langdale Notes to Editors Sources: 1 Briggs M, Nelson EA: Topical agents or dressings for pain in venous legulcers; The Cochrane Library, Issue 1, 2002 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 successfully listed through an initial public offering on theLondon 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