PVG.L Regulatory News (PVG)

1 Apr 2005 07:00

Ark Therapeutics Group PLC1 April 2005 Ark Grants Licence to Boehringer Ingelheim for Access to Key Technology 1 April 2005 - Ark Therapeutics Group plc today announces that it has signed anagreement with the German pharmaceutical company, Boehringer IngelheimInternational GmbH, granting Boehringer Ingelheim exclusive rights to Ark'sintellectual property in relation to certain Boehringer Ingelheim therapiesaffecting the renin-angiotensin system. Although detailed financial terms ofthe agreement were not disclosed, Ark receives a material upfront payment onsigning and several multi million Euro payments expected over the next few yearson the achievement of certain pre-defined milestones. In addition, Ark willreceive royalties on sales of a Boehringer Ingelheim product for the treatmentof patients in certain cardiovascular related indication areas for which Ark isable to secure and maintain a valid patent. There is increasing interest in the use of drugs which affect therenin-angiotensin system (a natural hormone cascade) in treating vascularrelated conditions. Ongoing clinical studies such as Boehringer Ingelheim'sPROFESS(R) and ONTARGET(TM)/ TRANSCEND trial program (1) are being performed inorder to accumulate clinical evidence about their effectiveness in reducing theincidence of such conditions. Market research data suggest the sales of thesecompounds is likely to increase significantly in the future as physicians switchto newer therapies in this growing market, driven by population aging and anincreasing prevalence of vascular disease-related events. Ark's intellectual property encompasses a fundamental discovery that chemicalswithin the body's renin-angiotensin system play a significant role indetermining the ability of mitochondria (2) to generate the energy for cells tosurvive. The scope of Ark's intellectual property covers the use of all agentswhich affect the renin-angiotensin system for the treatment of complexvascular-related and metabolic disorders. Dr Nigel Parker, Chief Executive of Ark Therapeutics, commented: "The novelwork of Ark's scientists and collaborators has contributed to a widerunderstanding of the potential utility of this class of drugs in a range ofdisorders. Whilst Boehringer Ingelheim is the first to acknowledge theimportance of Ark's discoveries in these areas, Ark may grant further licencesin the future to other companies." Paul Higham, Director of Commercial Development at Ark, commented: "We arepleased to have finalised this agreement with Boehringer Ingelheim in this verysignificant indication. We look forward to what we all hope will be thesuccessful completion of their clinical studies and to the registration ofBoehringer Ingelheim's products in these important areas of unmet need." 1.PROFESS(R): PReventiOn regimen For Effectively avoiding Second Stroke ONTARGET(TM): ONgoing Telmisartan Alone and in combination with Ramipril GlobalEndpoint Trial TRANSCEND: Telmisartan Randomized AssessmeNt Study in aCE iNtolerant subjectswith cardiovascular Disease 2. Mitochondria are cellular substructures considered to be the power station ofthe cell Ark Therapeutics Group plc +4420 7388 7722Dr Nigel Parker, CEOPaul Higham Director of Commercial Development Financial Dynamics +4420 7831 3113David YatesLucy Briggs Ark Therapeutics Group plc Ark is an emerging specialist healthcare group (the "Group") with one marketedproduct and four further lead products in late stage clinical development.Capitalising on over ten years of research in vascular biology and gene-basedmedicine, Ark has a balanced portfolio of proprietary healthcare productstargeted at specific unmet clinical needs predominantly with within vasculardisease and cancer. These are large and growing markets, where opportunitiesexist for effective new products to generate 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 and intends to conduct it'sown sales and marketing in certain territories as well as securing marketingpartners in others. The Group has operations in London, UK and Kuopio, Finland. Ark's shares are traded on the London Stock Exchange (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. Boehringer Ingelheim The Boehringer Ingelheim group is one of the world's 20 leading pharmaceuticalcompanies. Headquartered in Ingelheim, Germany, it operates globally with 152affiliates in 45 countries and more than 34,000 employees. Since it was foundedin 1885, the family-owned company has been committed to researching, developing,manufacturing and marketing novel products of high therapeutic value for humanand veterinary medicine. In 2003, Boehringer Ingelheim posted net sales of 7.4 billion euro whilespending more than one fifth of net sales in its largest business segmentPrescription Medicines on research and development. For more information please visit www.boehringer-ingelheim.com This information is provided by RNS The company news service from the London Stock Exchange