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Ark Therapeutics Group plc: Ark Strengthens International Patent Position on Leading Products

Posted on: 05/04/2005

Ark Therapeutics Group plc: Ark Strengthens International Patent Position on Leading Products

LONDON, May 4, 2005: Ark Therapeutics Group plc ("Ark" and the "Company"), today announces that it has been issued with several new patents for its products Vitor™ in Europe and also Central Africa, Cerepro™ in China, and Trinam® in Hungary.

Vitor™, an oral therapy for the treatment of muscle wasting (cachexia) that occurs in patients with cancer, has been granted patent protection in Europe and also in the ARIPO countries (Kenya, Malawi, Uganda and Zimbabwe), which can be both be maintained until 2018. Vitor™ is a small molecule in Phase III development in the USA, Canada and Europe. Ark expects to complete enrolment of the Phase III imminently, giving a target date for initial results to be available end of Q3 2005. Vitor™ works by enhancing mitochondrial activity and both reducing protein breakdown and enhancing protein synthesis in muscle cells via the ubiquitin-proteasome pathway. The MHRA recently advised that should the Phase III study results in cancer cachexia, due in H2 2005, show relevant and significant clinical benefits in the treatment’s favour, with an acceptable safety profile, then submission via the new decentralised procedure, which comes into effect later this year, would be appropriate.

Cerepro™, a product for the treatment of patients with operable malignant glioma, has been awarded a patent in China which can be maintained until 2019. The adenoviral mediated gene-based medicine (ad.HSV tk), given by multiple injections into the healthy brain tissue of patients following surgical removal of the solid tumour mass, is currently in late stage clinical development. Cerepro™ is suitable for patients with operable gliomas, of which there are approximately 38,0001 cases each year in Europe and the USA, and currently 9,000 cases estimated in China. With the progress made to date, Cerepro™ remains on track to become one of the world’s first commercially available gene-based medicines, following the first gene therapy licensing of P53 in China earlier this year.

Trinam®, a novel therapy to prevent blood vessels blocking after vascular graft access surgery, has been granted a patent in Hungary which can be maintained until 2017. Trinam® is currently in Phase II trials designed to examine the efficacy and safety of Trinam® in patients undergoing haemodialysis access graft surgery. In the US and Europe, there are an estimated 150,000 cases a year where Trinam® might be used. In patients with haemodialysis access grafts, up to 60% of the grafts block within a year of being inserted, and repeat surgery shows more rapid failure rates. Trinam® is expected to extend the useful life of access grafts and reduce costly repeat procedures. There are currently no approved drug therapies to reduce the failure rates of access graft procedures for haemodialysis patients.

Dr Nigel Parker, CEO of Ark, said, "We continue to make steady progress with the granting of our key product patents. Our strategy has been to ensure we secure patent protection in both traditional and less traditional key pharmaceutical markets. As the latter countries develop they are expected to provide a significant business opportunity."


Ark Therapeutics Group plc 020 7388 7722

Dr Nigel Parker, CEO

Financial Dynamics 020 7831 3113

Lucy Briggs

1 Source: Ark Research

Ark Therapeutics Group plc

Ark is a specialist healthcare group (the "Group") with one marketed product and three further lead products in late stage clinical development. Capitalising on over ten years of research in vascular biology and gene-based medicine, Ark has a balanced portfolio of proprietary healthcare products targeted at specific unmet clinical needs within vascular disease and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues.

Ark’s products are sourced from related but largely non-dependent technologies within the Group and have been selected to enable Ark to take each product through development and to benefit from Orphan Drug Status and/or Fast Track Designation, as appropriate. The Group generally retains ownership of its product candidates throughout clinical development. Ark has secured patents or has patent applications pending for all its lead products in principal pharmaceutical markets and retains the right to market its lead products in the key North American and European markets.

Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Dr 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 successfully listed through an initial public offering 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, prospective investors are cautioned not to rely on any forward-looking statement.

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