PVG.L Regulatory News (PVG)

27 Sep 2006 07:01

Ark Therapeutics Group PLC27 September 2006 Ark Announces UK Launch of Flaminal(R) Woundcare Treatment New anti-microbial gel effective against MRSA London, UK, 27 September 2006 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces that it is to launch Flaminal(R), a topicalanti-microbial wound care gel, in the UK on 1st October. Flaminal(R) will besold to hospitals and community nurses through Ark's existing UK salesforcewhich currently promotes Kerraboot(R), the Company's novel device for thetreatment of diabetic and venous leg ulcers. The launch follows Ark's successin securing price reimbursement from the UK NHS Business Service Authority,announced earlier in the year. Flaminal(R), which Ark has in-licensed from FlenPharma of Belgium, is a newnon-cytotoxic(1) alginate gel with anti-microbial properties utilising a novelenzyme system. This gel is indicated for wounds which show delayed healing as aresult of a local infection or high bacterial load. To date, clinical data hasshown that Flaminal(R) has up to three times the healing rate(2) compared withexisting products(3,4). Flaminal(R) is particularly effective againstStreptococcus pyogenes and methicillin-resistant Staphylococcus aureus (MRSA)(5), two of the most troublesome and difficult to manage pathogens in woundcare. Flaminal(R) will be made available in two formulations, Flaminal(R) for wetwounds and Flaminal(R) Hydro for drier wounds. The product will be positionedin the anti-microbial segment of the UK advanced wound care market, which iscurrently valued in excess of £30 million and has grown by more than 50%(6) overthe last two years. Flaminal(R) will offer a novel alternative to thesilver-based treatments that currently dominate the market. Flaminal(R) is listed in the October edition of the UK Drug Tariff at a price of£6.99 per 15g tube. Commenting on today's announcement, Paul Higham, Ark's Commercial Director,said: "Flaminal(R) is a highly differentiated wound care product, with a novel mode ofaction backed by strong clinical data. It is particularly effective inpreventing acquired wound infection and therefore promoting wound healing. Itslaunch is another development in our long-term strategy of building astand-alone wound care business in the UK, which we will continue to strengthenthrough further in-licensing and the development of our own products." Notes (1) D Van den Plas et al., Flaminal(R) Hydro combines non-cytotoxicity withantimicrobial activity, Wounds UK 2005. (2) Reduction in area of ulcer after four weeks' treatment (3) de la Brassinne M, Thirion L, Horvat LI. A novel method of comparingthe healing properties of two hydrogels in chronic leg ulcers. J Eur AcadDermatol Venereol. 2006 Feb;20(2):131-5. (4) Scanlon E, Karlsmark T, Leaper DJ, Carter K, Poulsen PB, Hart-HansenK, Hahn TW. Cost-effective faster wound healing with a sustainedsilver-releasing foam dressing in delayed healing leg ulcers - a health-economicanalysis. Int Wound J 2005; 2:150-160 (5) Source: FlenPharma in vitro data (6) Source: TNS Independent market data For further information please contact: Ark Therapeutics Group plc: +44 (0)20 7388 7722Dr Nigel Parker, Chief ExecutiveMartyn Williams, Chief Financial Officer Financial Dynamics: +44 (0)20 7831 3113David YatesAnna Keeble Notes to Editors Flaminal (R) and Flaminal(R) Hydro Flaminal(R) and Flaminal(R) Hydro contain proprietary biological anti-microbialenzyme systems providing protection from infections without toxicity to humancells. They maintain the wound in a humid environment, continuously debride thewound, restore bacterial balance and are both non-cytotoxic and hypoallergenic. Flaminal(R) is indicated for the following wounds: Highly exuding ulcers, oncologic wounds, second degree burns, post-operativewounds, pre-operative fibrinous wounds and bed sores. Flaminal(R) Hydro is indicated for the following wounds: Dermatosurgery, moderately exuding ulcers, second degree burns andpost-operative, moderately exuding wounds. Flaminal(R) and Flaminal(R) Hydro are CE-marked within the EU and approved forsale in China, Switzerland and Saudi Arabia. FlenPharma FlenPharma, established in November 2000, is a private Belgian companyspecialising in developing innovative and advanced treatments for wounds.FlenPharma's laboratories are based at Edegem, adjacent to the AntwerpUniversity Hospital and University campus. Ark Therapeutics Group plc Ark is a specialist healthcare group (the "Group"), addressing high value areasof clear unmet medical need. With one marketed product, Kerraboot(R), and threefurther lead products in late stage clinical development: VitorTM, CereproTM andTrinam(R), the Group is transitioning from an R&D focused company to acommercial, revenue generating business. Capitalising on over ten years ofresearch in vascular biology and gene-based medicine, Ark has a broad productportfolio targeted at specific unmet clinical needs within vascular disease,wound care and cancer. These are large and growing markets, where opportunitiesexist for effective new products to generate significant revenues. CereproTM ison track to becoming one of the world's first commercially available gene-basedmedicines. 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