PVG.L Regulatory News (PVG)

20 Oct 2008 07:00



Ark announces NHS reimbursement and launch of KerraMax® Super-absorbent Dressing

Further addition to woundcare product range to be marketed from 1 November 2008

London, UK, 20 October 2008 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces that reimbursement approval has been secured from the UK NHS Business Services Authority for KerraMax®, the Company's novel super-absorbent dressing for the management of leg ulcers. Following listing in the NHS Drug Tariff, Ark intends to launch the product on 1 November 2008. 

KerraMax® is a super-absorbent primary dressing for use in the management of moderate to heavy exudate in chronic leg ulcer wounds of venous etiology, with particular application for use under mild to moderate compression bandaging. The product is based on the proprietary super-absorbent used in Ark's product, Kerraboot®, which demonstrates up to 70% more absorptive capacity than conventional foam dressings. KerraMax® will be marketed by Ark's existing woundcare salesforce which currently promotes Kerraboot®, Kerraped® and Flaminal®, and will be available in two sizes (10x22 cm and 20x22 cm) listed in the Drug Tariff at £1.02 and £1.80 respectively.

Leg ulcers due to venous insufficiency affect 1.2 - 3.2 people per 1,000 of the adult population representing 72,000-192,000 cases a year (Ref 1). Standard care is usually the application of compression bandages over a sterile absorbent dressing, placed on the wound. The success of treatment is in part dependent on the length of time each dressing can be applied, as well as the ability of the absorbent primary dressing to take up exudate. KerraMax® offers a significant absorbency advantage over existing dressings with its enhanced ability to 'absorb and lock in' exudate even whilst under mild to moderate compression bandaging.

Venous leg ulcers present some of the most difficult treatment challenges due to the high levels of wound exudate that they can produce. Managing and treating venous leg ulcers is estimated to cost the NHS up to £300 million per annum (Ref 2). The UK market for existing absorbent dressings is currently estimated at £10 million per annum (Ref 3).

Commenting on today's announcement, Cécile Miles, Ark's Commercial Director, said:

"Chronic leg ulcer wounds are a major problem affecting many thousands of patients and they are both difficult and costly to manage. KerraMax® is an excellent product offering significant absorbency benefits in dealing with exudate and we believe that it will bring significant benefits to patients suffering from leg ulcers and to the nurses who treat them."

Dr Nigel Parker, CEO of Ark, added:

"We are very pleased to announce the reimbursement approval of KerraMax® and its launch in November. This product will be the second woundcare product launched by Ark since the summer, complementing our existing range of products and delivering on our commitment to build our woundcare portfolio."

Ref 1 Graham, I,D. et al (2003) Prevalence of lower limb ulceration: a systematic review of prevalence studies. Advances in Skin

and Wound Care; 16:6,305-316

Ref 2. Nelson, E,A. et al. Randomised clinical trial of four-layer and short-stretch compression bandages for venous leg ulcers

(venUS1) British Journal of Surgery 2004; 91:1292-1299

Ref 3. Company estimates based on various published data

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Notes to Editors

Ark Therapeutics Group plc

Ark Therapeutics Group plc is a specialist healthcare group (the "Group") addressing high value areas of unmet medical need within vascular disease, wound care and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues. With four marketed devices, Kerraboot®, Kerraped®, Flaminal® and Neuropad®, and three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam®, the Group is transitioning from an R&D company to a commercial, revenue generating business.

Ark's own products are sourced from related but largely non-dependent technologies within the Group and have been selected to enable them to be taken through development within the Group's own means and to benefit from Orphan Drug Status and/or Fast Track Designation, as appropriate. This strategy has allowed the Group to retain greater value and greater control of clinical development timelines, and to mitigate the risks of dependency on any one particular programme or development partner. Ark has secured patents or has patent applications pending for all its lead products in principal pharmaceutical markets. 

Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Mr Stephen Barker of University College London and Professor Seppo Yla-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland, all of whom play leading roles in the Company's research and development 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 all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.