PVG.L Regulatory News (PVG)

8 Oct 2007 07:00

Ark Therapeutics Group PLC08 October 2007 Ark Therapeutics Group plc Ark outlicenses marketing rights for Ox-LDL heart attack risk test kit to Lab21 8 October 2007 - London UK: Ark Therapeutics Group plc ("Ark" or the "Company")today announces that it has signed an exclusive agreement to out-license the UKand international commercialisation rights to its oxidized low densitylipoprotein ("Ox-LDL") auto-antibody diagnostic test kit (EG010) to Lab21Limited, a UK-based private diagnostics company. EG010 assesses the risk of apatient having a heart attack. EG010 has been CE marked for use in Europe. Data from a clinical trial of 121patients entering hospital with chest pain showed the correlation between apositive test result and heart attack was 80%. Under the terms of theagreement, Lab21 will conduct a further prospective clinical trial toinvestigate the additional predictive characteristics of EG010, take on thefinal automation and test optimisation prior to launch and thereafter carry outall sales and marketing activities. Ark is due a mix of up-front and milestonecash 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 cardiovasculardisease. Cardiovascular care costs the UK NHS £14.7bn/year in 2003, the latestyear of published statistics provided by the British Heart Foundation 2007report. At present a range of cardiovascular blood lipid (high density lipoprotein, lowdensity lipoprotein, triglycerides and cholesterol) tests are used by cliniciansto build up a general cardiovascular risk profile for a patient as no singletest is sufficiently predictive in isolation. Ox-LDL is released fromatherosclerotic plaque in increasing amounts as the plaque becomes moreunstable, and thus with the increasing likelihood that an area of it will breakaway from the surface of the blood vessel and obstruct either the coronaryartery (causing a heart attack) or a cerebral vessel (causing a stroke).Because Ox-LDL has a very short half life within the blood, measuring itaccurately is difficult. However, the body rapidly produces auto-antibodies andthese can be measured by developing appropriate antigens. Ark's EG010 test isan elisa-based kit where the antigen has been specifically optimised to the keyantibody epitopes recognised as being important in the prediction of heartattack risk. Commenting on the agreement, Paul Higham, Commercial Director at Ark said: "We are pleased to have concluded this agreement with Lab21. Their analysis ofthe product opportunity and their detailed marketing plans have been impressiveand a key factor in our decision to choose Lab21 as our commercialisationpartner. With their expanding diagnostics business and future growth plans webelieve their enthusiasm and approach make them an ideal partner in ensuringthis product's success." Dr Jerry Walker, CEO at Lab21 added: "The in-licensing of this product presentsa tremendously exciting opportunity for Lab21. Not only does this assayrepresent a step forward in defining the nature of cardiovascular disease, italso consolidates Lab21's position as a leading company in the development ofpersonalised medicine. We are delighted to have been given the opportunity tolicense this IP from Ark and we look forward to a successful partnership as wecommence commercialisation of the test." For further information please contact: Ark Therapeutics Group plc +44 (0)20 7388 7722Dr Nigel Parker, Chief Executive OfficerMartyn Williams, Chief Financial Officer Financial Dynamics +44 (0)20 7831 3113David Yates/Lara Mott Lab21 LimitedDr Jerry Walker, Chief Executive Officer +44 (0)1223 395450Dr Berwyn Clarke, Chief Scientific Officer Notes to Editors Lab21 Limited Lab21 is a leading provider of cutting edge diagnostics, supporting drugdiscovery, healthcare and environmental monitoring. Its customers includehealthcare providers, pharmaceutical and biotechnology companies, in addition toorganisations that need to monitor their impact on the environment. Lab21 has a rapidly growing portfolio of diagnostics to support early stage drugdevelopment, clinical trials and regulatory processes in the pharmaceuticalindustry and to support clinicians and healthcare providers as they treat andmonitor patients. The company's products include diagnostic tests for cancer, liver disease,respiratory illnesses and infectious diseases such as syphilis through itssubsidiary Newmarket Laboratories. Its pharmaceutical support services whichfocus on anti-viral programmes include lead identification and optimisation oftargets, drug resistance profiling, mode of action studies, and drug combinationstudies as well as clinical trial support. The Lab21 group includes MTI (Monitoring Technologies International), a companyspecialising in the development of environmental monitoring instruments, andNewmarket Laboratories, which specialises in the development and production ofhigh-quality immunodiagnostics for infectious diseases. Website: www.lab21.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, woundcare and cancer. These are large and growing markets, where opportunities existfor effective new products to generate significant revenues. With three marketeddevices, Kerraboot(R), Kerraped(R) and Flaminal(R), and three further leadpharmaceutical products in late stage clinical development: Cerepro(R), VitorTM,and Trinam(R), 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-dependenttechnologies within the Group and have been selected to enable them to be takenthrough development within the Group's own means and to benefit from Orphan DrugStatus and/or Fast Track Designation, as appropriate. This strategy has allowedthe Group to retain greater value and greater control of clinical developmenttimelines, and to mitigate the risks of dependency on any one particularprogramme or development partner. Ark has secured patents or has patentapplications pending for all its lead products in principal pharmaceuticalmarkets. Ark has its origins in businesses established in the mid-1990s by Professor JohnMartin and Mr Stephen Barker of University College London and Professor SeppoYla-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland,all of whom play leading roles in the Company's research and developmentprogrammes. Ark's shares were first listed on the London Stock Exchange in March 2004(AKT.L). This announcement includes "forward-looking statements" which include allstatements other than statements of historical facts, including, withoutlimitation, those regarding the Group's financial position, business strategy,plans and objectives of management for future operations (including developmentplans and objectives relating to the Group's products and services), and anystatements preceded by, followed by or that include forward-looking terminologysuch as the words "targets", "believes", "estimates", "expects", "aims","intends", "will", "can", "may", "anticipates", "would", "should", "could" orsimilar expressions or the negative thereof. Such forward-looking statementsinvolve known and unknown risks, uncertainties and other important factorsbeyond the Group's control that could cause the actual results, performance orachievements of the Group to be materially different from future results,performance or achievements expressed or implied by such forward-lookingstatements. Such forward-looking statements are based on numerous assumptionsregarding the Group's present and future business strategies and the environmentin which the Group will operate in the future. Among the important factors thatcould cause the Group's actual results, performance or achievements to differmaterially from those in forward-looking statements include those relating toArk's funding requirements, regulatory approvals, clinical trials, reliance onthird parties, intellectual property, key personnel and other factors. Theseforward-looking statements speak only as at the date of this announcement. TheGroup expressly disclaims any obligation or undertaking to disseminate anyupdates or revisions to any forward-looking statements contained in thisannouncement to reflect any change in the Group's expectations with regardthereto or any change in events, conditions or circumstances on which any suchstatements are based. As a result of these factors, readers are cautioned not torely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange