PVG.L Regulatory News (PVG)

21 Jun 2006 07:01

Ark Therapeutics Group PLC21 June 2006 Ark strengthens UK wound care portfolio with in-licensing of Flaminal(R) Prescription Pricing Authority approves NHS reimbursement price 21 June 2006, London, UK: Ark Therapeutics Group plc ("Ark") announces todaythat it has signed an exclusive agreement with Flen Pharma, the private Belgianwound care company, giving Ark the rights to market Flaminal(R), ananti-microbial wound care gel, in the UK. Under the terms of the deal, Ark willbe responsible for reimbursement and conducting all sales and marketingactivities and will pay Flen Pharma a transfer price for the finished product.Ark's existing sales force, which currently markets Kerraboot(R), a product fordiabetic and venous leg ulcers, will be used to promote Flaminal(R) in the UK. Flaminal(R) is a new non-cytotoxic(1) alginate gel with anti-microbialproperties utilising a novel enzyme system. This gel is indicated for woundswhich show delayed healing as a result of a local infection or high bacterialload. To date, clinical data has shown that Flaminal(R) has up to three timesthe healing rate(2) compared with existing products(3,4). Flaminal(R) isparticularly effective against Streptococcus pyogenes and methicillin-resistantStaphylococcus aureus (MRSA)(5), two of the most troublesome and difficult tomanage pathogens in wound care. 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-infectives 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) was reviewed in May 2006 by the UK Prescription Pricing Authorityand has been approved for listing in the Drug Tariff with a reimbursement priceof £6.99 per 15g tube. Paul Higham, Commercial Director of Ark, commented: "Flaminal(R) presents uswith a very exciting marketing opportunity and we expect the product to secure asignificant market share. The clinical data is impressive and we believe itoffers considerable advantages over existing products." Nigel Parker, CEO of Ark, commented: "This deal demonstrates our continuedcommitment to building our wound care and devices division. It allows us toleverage our UK sales infrastructure for Kerraboot(R) and we aim to continue tostrengthen and expand our product range, both by in-licensing and by thein-house development of our own new products. We look forward to bringingFlaminal(R) to market later this year." Notes (1) D Van den Plas et al., Flaminal(R) Hydro combines non-cytotoxicity with antimicrobial 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 comparing the healing properties of two hydrogels in chronic leg ulcers. J Eur Acad Dermatol Venereol. 2006 Feb;20(2):131-5. (4) Scanlon E, Karlsmark T, Leaper DJ, Carter K, Poulsen PB, Hart-Hansen K, Hahn TW. Cost-effective faster wound healing with a sustained silver-releasing foam dressing in delayed healing leg ulcers - a health-economic analysis. Int Wound J 2005; 2:150-160 (5) Source: Flen Pharma (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. Flen Pharma Flen Pharma, 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 Antwerp UniversityHospital 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 andTrinamTM, 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. 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