PVG.L Regulatory News (PVG)

17 Jun 2009 07:00



Ark and AOTI sign international medical device sales collaboration on Kerraboot®

London 17 June 2009 - Ark Therapeutics Group Plc ("Ark" or "the Company") announces today that it has signed an agreement with the privately owned global woundcare company, AOTI Ltd. (AOTI), for the supply of Kerraboot® in conjunction with AOTI's new Topical Wound Oxygen Therapy, known as TWO2, for the treatment of problematic chronic wounds. The initial agreement under which AOTI will purchase Kerraboot® from Ark is for two years and includes projected sales numbers with minimum purchase commitments.

The new treatment regime combining TWO2 therapy with Kerraboot® will involve the application of AOTI's unique cyclical pressure topical oxygen therapy with the use of Ark's Kerraboot® between each treatment. TWO2 has been shown to completely heal complex wounds by correcting local tissue oxygen balance, stimulating angiogenic growth factors and the granulation of highly collagenous tissue and reducing bacterial bio-burden and peripheral oedema1. Kerraboot® provides an easy to apply and pain free interim wound management dressing. The agreement anticipates that Kerraboot® will be used extensively in lower limb wounds treated with TWO2. 

Under the agreement, Ark has granted AOTI exclusive international rights to purchase Kerraboot® for use in this novel treatment approach which has demonstrated significant increases in healing rates for these problematic wounds.

The new combined TWO2-Kerraboot® regimen will be launched immediately, commencing in the US, Germany, France, Russia and the Middle East.

Cecile Miles, Commercial Director at Ark, commented: "We are very pleased to announce this important agreement. The combination of TWO2 and Kerraboot® is a logical approach and the effect of the two products together should be highly beneficial to patients whose quality of life can be very poor owing to the presence of these chronic and frequently distressing wounds."

Dr Nigel Parker, CEO of Ark, added: "Kerraboot® has already been shown to be highly effective in managing leg ulcers. This agreement with AOTI will allow both companies to significantly expand product usage in a controlled clinical treatment regimen. The opportunities in the US alone are very significant with in excess of five million people1 having either diabetic or venous leg ulcers. We look forward to providing a further update on the progress of this initiative in due course."

Mike Griffiths, CEO of AOTI, commented: "We are delighted to be partnering with such a pioneering company as Ark. We believe that the combination of our proven TWO2 therapy with Ark's innovative Kerraboot® will further enhance the exceptional wound closure effectiveness we have been seeing in recent clinical trials."

1 AOTI Website

For further information:

Notes to editors 

AOTI Ltd.

AOTI Ltd. is a global woundcare company with manufacturing facilities in Galway, Ireland and New Jersey USA, as well as sales and marketing offices in California and Florida, USA, Dusseldorf, Germany and Cairo, Egypt. AOTI was founded on over a decade of experience in providing innovative solutions to resolve severe and chronic wounds. Its patented Topical Wound Oxygen Therapy (TWO2) product range is unsurpassed in completely closing diabetic, venous and pressure ulcers alike

 For more information, see www.aotinc.net.

Kerraboot®

Kerraboot® provides a new approach to the management of foot and leg ulcers, in the form of a novel, non pressurised, boot-like dressing device, which is simple, quick and mostly pain free to change. Kerraboot® facilitates the draining and isolation of exudates, such as matrix metalloproteases, which inhibit angiogenesis, from the ulcer. This allows natural growth factors, such as Vascular Endothelial Growth Factors (VEGF), to stimulate healing. In clinical studies of ulcers managed with Kerraboot® reductions in ulcer size of up to 60% has been observed over the four-week study period, with both healthcare professionals and patients expressing a strong preference for Kerraboot®  over existing treatments. These UK-based studies have also shown that management of ulcers with Kerraboot®, which does not involve any additional dressings, can be extremely cost effective, saving up to 50% of nurse time and with patients often becoming nurse independent. 

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 five marketed devices, Kerraboot®, Kerraped®, Flaminal®, Neuropad® and KerraMax® 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 both 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, where 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 Ylä-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.