Clinical diagnostic services
Clinical diagnostic products
05.10.07
Ark outlicenses marketing rights for Ox-LDL heart attack risk test kit to Lab21
London, 5 October 2007 Ark Therapeutics Group plc (“Ark” or the “Company”) today announces that it has signed an exclusive agreement to out-license the UK and international commercialisation rights to its oxidized low density lipoprotein (“Ox-LDL”) auto-antibody diagnostic test kit (EG010) to Lab21 Limited, a UK-based private diagnostics company. EG010 assesses the risk of a patient having a heart attack.
EG010 has been CE marked for use in Europe. Data from a clinical trial of 121 patients entering hospital with chest pain showed the correlation between a positive test result and heart attack was 80%. Under the terms of the agreement, Lab21 will conduct a further prospective clinical trial to investigate the additional predictive characteristics of EG010, take on the final automation and test optimisation prior to launch and thereafter carry out all sales and marketing activities. Ark is due a mix of up-front and milestone cash and future equity payments, together with a 5% royalty on future sales.
Currently, 1 in 5 males and 1 in 6 females in the UK die of cardiovascular disease. Cardiovascular care cost the UK NHS £14.7bn/year in 2003 the latest year of published statistics provided by the British Heart Foundation 2007 report.
At present a range of cardiovascular blood lipid (high density lipoprotein, low density lipoprotein, triglycerides and cholesterol) tests are used by clinicians to build up a general cardiovascular risk profile for a patient as no single test is sufficiently predictive in isolation. Ox-LDL is released from atherosclerotic plaque in increasing amounts as the plaque becomes more unstable, and thus with the increasing likelihood that an area of it will break away from the surface of the blood vessel and obstruct either the coronary artery (causing a heart attack) or a cerebral vessel (causing a stroke). Because Ox-LDL has a very short half life within the blood, measuring it accurately is difficult. However, the body rapidly produces auto-antibodies and these can be measured by developing appropriate antigens. Ark’s EG010 test is an elisa-based kit where the antigen has been specifically optimised to the key antibody epitopes recognised as being important in the prediction of heart attack risk.
Commenting on the agreement, Paul Higham, Commercial Director at Ark said:
“We are pleased to have concluded this agreement with Lab21. Their analysis of the product opportunity and their detailed marketing plans have been impressive and a key factor in our decision to choose Lab21 as our commercialisation partner. With their expanding diagnostics business and future growth plans we believe their enthusiasm and approach make them an ideal partner in ensuring this product’s success.”
Dr Jerry Walker, CEO at Lab21 added: “The in-licensing of this product presents a tremendously exciting opportunity for Lab21. Not only does this assay represent a step forward in defining the nature of cardiovascular disease, it also consolidates Lab21’s position as a leading company in the development of personalised medicine. We are delighted to have been given the opportunity to license this IP from Ark and we look forward to a successful partnership as we commence commercialisation of the test”.
For further information please contact:
Ark Therapeutics Group plc
+44 (0)20 7388 7722
Dr Nigel Parker, Chief Executive Officer
Martyn Williams, Chief Financial Officer
Financial Dynamics
+44 (0)20 7831 3113
David Yates/Lara Mott
Lab21 Limited
+44 (0)1223 395450
Dr Jerry Walker, Chief Executive Officer
Dr Berwyn Clarke, Chief Scientific Officer
Notes to editors
About Lab21 Ltd.
Lab21 is a leading provider of cutting edge diagnostics, supporting drug discovery, healthcare and environmental monitoring. Its customers include healthcare providers, pharmaceutical and biotechnology companies in addition. The Company supports organisations that need to monitor their impact on the environment.
Lab21 has a rapidly growing portfolio of diagnostics to support early stage drug development, clinical trials and regulatory processes in the pharmaceutical industry. A key function is the support of clinicians and healthcare providers as they treat and monitor patients.
The company’s products include diagnostic tests for cancer, liver disease, respiratory illnesses and infectious diseases such as syphilis through its subsidiary Lab21 Healthcare. Its pharmaceutical support services which focus on anti-viral programmes include lead identification and optimisation of targets, drug resistance profiling, mode of action studies, and drug combination studies as well as clinical trial support.
The Lab21 group includes MTI (Monitoring Technologies International), a company specialising in the development of environmental monitoring instruments, and Lab21 Healthcare, which specialises in the development and production of high-quality immunodiagnostics for infectious diseases.
Website: www.lab-21.com
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 three marketed devices, Kerraboot®, Kerraped® and Flaminal®, 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.
