PVG.L Regulatory News (PVG)

28 Oct 2005 07:01

Ark Therapeutics Group PLC28 October 2005 CereproTM Marketing Authorisation Application Review Commences in Europe - Dossier for potentially the world's first gene therapy product 1 accepted by EMEA as "valid" - 28 October 2005: Ark Therapeutics Group plc ("Ark") today announces that itsMarketing Authorisation Application (MAA) for CereproTM, a novel gene-basedtherapy for operable malignant glioma (brain cancer), has been filed with theEuropean medicines regulatory authority, the EMEA, and that the application hasbeen accepted for review. The application for CereproTM, a designated Orphan Drug, has met the submissionrequirements of the important validation stage, and formal review by theregulators has commenced. Earlier in the year, the Company announced that theEMEA had appointed Rapporteurs to review the MAA via the centralised regulatoryprocess, which is the standard route for all biologics, and more recently Arkhas announced that its Finnish manufacturing facility had received a licence tomanufacture CereproTM for commercial supply. The Company is also announcing ina separate press release today that it has commenced a corroborative study ofCereproTM, Study 904, in up to 250 patients. CereproTM, a novel gene-based medicine, has undergone three clinical studiesduring its development to date, a Phase I study establishing safety and posology(dosing and method of administration) and two safety and efficacy studies. Inthese studies CereproTM treatment produced an average extension of 7.5 months oflife, giving around 15.5 months survival in a disease where most patientscurrently only live for around 8 months. CereproTM has Orphan Drug Status inEurope and the USA and is manufactured by Ark in Finland. Dr David Eckland, Research and Development Director at Ark, said: "We areworking in a breakthrough area of medicine, and acceptance of the CereproTM fileby the regulatory authorities in Europe is an enormous achievement and the keymilestone that we have been seeking for this product. The regulatoryauthorities have been extremely supportive throughout this process and we lookforward to working with them during the review." Dr Nigel Parker, CEO of Ark, commented: "If the review by the EMEA issuccessful, CereproTM will be the world's first gene therapy product1. Anincreasing body of evidence suggests that gene therapy has the potential todeliver solutions for many diseases that are untreatable today and Ark israpidly becoming recognised as the world leader in this frontier area ofmedicine." 1 Outside China A conference call for analysts will be held today at 09.00am BST. For dial indetails please contact Mo Noonan on 0044 (0)207 269 7116. For further information, please contact: Ark Therapeutics Group plc 020 7388 7722 Dr Nigel Parker, CEO Mr Martyn Williams CFO Financial Dynamics 020 7831 3113 David Yates / Davina Langdale Notes to Editors Malignant glioma Malignant glioma is a devastating and fatal form of brain tumour that is usuallyconfined to the brain. The current standard therapy involves surgicallyremoving the solid tumour mass (when possible) and initiating radiotherapy and/or chemotherapy. Even with the latest approved treatments, most patients diewithin one year of diagnosis, with average survival being about eight months.Little therapeutic progress has been made in recent years and the prognosis formalignant glioma patients is poor. A high unmet clinical need exists for newtreatments that prolong life in this devastating disease. There areapproximately 16,000 cases of malignant glioma in the EU which are operable. CereproTM CereproTM is an adenoviral mediated gene based medicine (ad.HSV tk) given bymultiple injections into the healthy brain tissue of patients following surgicalremoval of the solid tumour mass. In the following days, ganciclovir, is givenintravenously. Once treated, healthy brain cells surrounding the site where thetumour was removed express the enzyme thymidine kinase. This converts theganciclovir to a substance which specifically kills dividing cells. The healthyneurones surrounding the tumour in the brain are non-dividing and are thereforenot susceptible to this substance. In this way CereproTM harnesses healthybrain cells to help prevent a new tumour from growing. Ark Therapeutics Group plc Ark is an emerging healthcare group (the "Group") now entering thecommercialisation phase, with one product introduced into hospitals and threefurther lead products in late stage clinical development. Capitalising on overten years of research in vascular biology and gene-based medicine, Ark has abalanced portfolio of proprietary healthcare products targeted at specific unmetclinical needs within vascular disease and cancer. These are large and growingmarkets, where opportunities exist for effective new products to generatesignificant 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 in thekey North American and European markets. 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 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, 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