Ark Secures Reimbursement For Neuropad(R) From UK NHS Business Services Authority, UK

Main Category: Diabetes
Article Date: 03 Oct 2008 - 2:00 PST

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Ark Therapeutics Group plc ("Ark" or the "Company") today announces that it has successfully achieved reimbursement from the UK NHS Business Services Authority for Neuropad®, an innovative diagnostic test to detect early stage peripheral autonomic neuropathy in the feet of diabetic patients. Neuropad® is the first product in a new diagnostic class to be available to the NHS on prescription.

Neuropad® will be promoted to the primary care community from 1 November 2008 after its listing in the Drug Tariff at a price of £6.99. Ark will market Neuropad® through its existing UK salesforce which currently markets the Company's wound care products, Kerraboot®, Kerraped® and Flaminal®.

Diabetic foot syndrome frequently results in foot ulcers which are both distressing for the patient and difficult to treat as well as being a significant financial burden to the NHS. Neuropad® assesses the status of the sweat gland (sudomotor) response by measuring the moisture status of the foot. An abnormal sweat gland response is closely correlated with the onset of peripheral autonomic neuropathy in the feet.

Current screening tools for the early detection of the diabetic foot syndrome in primary care require a subjective patient response and rely on the skill of healthcare professionals. However, autonomic neuropathy affects small fibres much earlier in the disease process (in most cases) and Neuropad®, unlike the currently available tests in primary care, will detect this damage when patients are asymptomatic of large fibre damage.

Neuropad® has been designed to be safe, non-invasive and easily applied in a primary care setting, including long term residential or nursing care, and can be applied without additional training by practice nurses and community podiatrists as they perform routine screening of their diabetic patients. Neuropad® supports the NHS Quality Outcomes Framework which recommends that all diabetic patients are assessed for peripheral neuropathy every 15 months.

Early identification of neuropathy using Neuropad® will reduce the incidence of diabetic foot ulcers by allowing timely preventative measures to be implemented. The cost to the NHS of treating a foot ulcer is estimated to be £5,200 and as many as 64,000 diabetic patients are likely to develop an open ulcer in any one year1.

Commenting on today's announcement, Cecile Miles, Ark's Commercial Director, said: "This is very good news for our growing wound care business. Since Neuropad® is very sensitive and able to detect early neuropathy, we believe it will have a significant impact on the quality of diabetic foot screening available to patients, reducing both patient suffering and the clinical and cost burden of diabetic ulcers to the NHS."

Dr Nigel Parker, CEO of Ark, added: "The process of securing reimbursement is taking an increasingly long time and we are very pleased to have got this through. Neuropad® is an ideal fit with Ark's wound care strategy of introducing innovative products that deliver both clinical benefits and savings to the healthcare system. This news is in line with our plan to launch at least two new products during this year."

References

1 Posnet J, Franks P J. The burden of chronic wounds in the UK. 2008. Nursing Times. 104:3. 44 - 45.
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).

Ark Therapeutics Group plc