PVG.L Regulatory News (PVG)

22 Apr 2008 07:00

Ark Therapeutics Group PLC22 April 2008 Ark Therapeutics Group plc Ark receives positive opinion letter from EMEA for Cerepro(R) Paediatric Investigation Plan London, UK, 22 April 2008 - Ark Therapeutics Group plc ("Ark" or the "Company")today announces that the Paediatric Committee at the European Medicines Agency(EMEA) has given a positive opinion on the Company's Investigation Plan forCerepro(R) in paediatric patients with high grade glioma. The opinion wasadopted by the Committee on 11 April 2008. As from 26 July 2008, the new European Paediatric Use Regulation requires allnew products seeking marketing authorisation in the EU to have an approved planto ensure they are developed appropriately for the paediatric population. The plan allows Ark to develop Cerepro(R) for operable high grade glioma inchildren from 1 month up to 18 years old. The paediatric work will not commenceuntil a European Marketing Authorisation for Cerepro has been granted for thetreatment of adults; the Company has been allowed 4 years to complete the work. Dr Nigel Parker, CEO at Ark commented: "We continue to be successful inadvancing the regulatory process for this breakthrough product. Acceptance ofthe Paediatric Investigation Plan is now an essential part of the centralisedregulatory approval process in Europe and we are very pleased to havesuccessfully achieved this step. Although paediatric cases of glioma arerelatively few, it is clearly important that products such as Cerepro(R) aremade available to them." For further information: Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722Dr Nigel Parker, CEOMartyn Williams, CFO Financial Dynamics Tel: +44 (0)20 7831 3113David YatesSusan Quigley Notes to Editors High grade glioma High grade glioma (malignant glioma) is a devastating and fatal form of tumourthat is usually confined to the brain. The current standard therapy involvessurgically removing the solid tumour mass (when possible) and initiatingradiotherapy and/or chemotherapy. Even with the latest approved treatments,most patients die within one year of diagnosis, with average survival beingabout eight months. Little therapeutic progress has been made in recent yearsand the prognosis for malignant glioma patients is poor. A high unmet clinicalneed exists for new treatments that prolong life in this devastating disease. Itis estimated that there are approximately 16,000 cases of malignant glioma inthe EU which are operable. Cerepro(R) Cerepro(R) 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 Cerepro(R) harnesses healthybrain cells to help prevent a new tumour from growing. 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 four marketeddevices, Kerraboot(R), Kerraped(R), Flaminal(R) and Neuropad(R), and threefurther lead pharmaceutical products in late stage clinical development: Cerepro(R), VitorTM, and Trinam(R), the Group is transitioning from an R&D company to acommercial, 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