PVG.L Regulatory News (PVG)

4 May 2005 07:00

Ark Therapeutics Group PLC04 May 2005 Ark Therapeutics Group plc Ark strengthens international patent position on leading products London, UK, 4th May 2005: Ark Therapeutics Group plc ("Ark" and the "Company"),today announces that it has been issued with several new patents for itsproducts Vitor(TM) in Europe and also Central Africa, Cerepro(TM) in China, andTrinam(R) in Hungary. Vitor(TM), an oral therapy for the treatment of muscle wasting (cachexia) thatoccurs in patients with cancer, has been granted patent protection in Europe andalso in the ARIPO countries (Kenya, Malawi, Uganda and Zimbabwe), which can beboth be maintained until 2018. Vitor(TM) is a small molecule in Phase IIIdevelopment in the USA, Canada and Europe. Ark expects to complete enrolment ofthe Phase III imminently, giving a target date for initial results to beavailable end of Q3 2005. Vitor(TM) 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(TM), a product for the treatment of patients with operable malignantglioma, has been awarded a patent in China which can be maintained until 2019.The adenoviral mediated gene-based medicine (ad.HSV tk), given by multipleinjections into the healthy brain tissue of patients following surgical removalof the solid tumour mass, is currently in late stage clinical development.Cerepro(TM) is suitable for patients with operable gliomas, of which there areapproximately 38,000 (1) cases each year in Europe and the USA, and currently9,000 cases estimated in China. With the progress made to date, Cerepro(TM)remains on track to become one of the world's first commercially availablegene-based medicines, following the first gene therapy licensing of P53 in Chinaearlier this year. Trinam(R), a novel therapy to prevent blood vessels blocking after vasculargraft access surgery, has been granted a patent in Hungary which can bemaintained until 2017. Trinam(R) is currently in Phase II trials designed toexamine the efficacy and safety of Trinam(R) in patients undergoinghaemodialysis access graft surgery. In the US and Europe, there are anestimated 150,000 cases a year where Trinam(R) might be used. In patients withhaemodialysis access grafts, up to 60% of the grafts block within a year ofbeing inserted, and repeat surgery shows more rapid failure rates. Trinam(R)is expected to extend the useful life of access grafts and reduce costly repeatprocedures. There are currently no approved drug therapies to reduce thefailure rates of access graft procedures for haemodialysis patients. Dr Nigel Parker, CEO of Ark, said, "We continue to make steady progress with thegranting of our key product patents. Our strategy has been to ensure we securepatent protection in both traditional and less traditional key pharmaceuticalmarkets. As the latter countries develop they are expected to provide asignificant business opportunity." Enquiries: Ark Therapeutics Group plc 020 7388 7722Dr Nigel Parker, CEO Financial Dynamics 020 7831 3113Lucy Briggs 1. Source: Ark Research Ark Therapeutics Group plc Ark is a specialist healthcare group (the "Group") with one marketed product andthree further lead products in late stage clinical development. Capitalising onover ten years of research in vascular biology and gene-based medicine, Ark hasa balanced portfolio of proprietary healthcare products targeted at specificunmet clinical needs within vascular disease and cancer. These are large andgrowing markets, where opportunities exist for effective new products togenerate significant revenues. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable Ark to take each productthrough development and to benefit from Orphan Drug Status and/or Fast TrackDesignation, as appropriate. The Group generally retains ownership of itsproduct candidates throughout clinical development. Ark has secured patents orhas patent applications pending for all its lead products in principalpharmaceutical markets and retains the right to market its lead products inthe key North American and European markets. Ark has its origins in businesses established in the mid-1990s by Professor JohnMartin and Dr 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 anddevelopment programmes. Ark's shares were successfully listed through an initial public offering on theLondon 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, prospective investors arecautioned not to rely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange