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CereproTM Marketing Authorisation Application Review Commences in Europe

Posted on: 10/28/2005

CereproTM Marketing Authorisation Application Review Commences in Europe

Ark Therapeutics (UNITED KINGDOM)
October 28, 2005
- 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 its Marketing Authorisation Application (MAA) for CereproTM, a novel gene-based therapy for operable malignant glioma (brain cancer), has been filed with the European medicines regulatory authority, the EMEA, and that the application has been accepted for review.

The application for Cerepro™, a designated Orphan Drug, has met the submission requirements of the important validation stage, and formal review by the regulators has commenced. Earlier in the year, the Company announced that the EMEA had appointed Rapporteurs to review the MAA via the centralised regulatory process, which is the standard route for all biologics, and more recently Ark has announced that its Finnish manufacturing facility had received a licence to manufacture CereproTM for commercial supply. The Company is also announcing in a separate press release today that it has commenced a corroborative study of Cerepro™, Study 904, in up to 250 patients.

Cerepro™, a novel gene-based medicine, has undergone three clinical studies during its development to date, a Phase I study establishing safety and posology (dosing and method of administration) and two safety and efficacy studies. In these studies Cerepro™ treatment produced an average extension of 7.5 months of life, giving around 15.5 months survival in a disease where most patients currently only live for around 8 months. CereproTM has Orphan Drug Status in Europe and the USA and is manufactured by Ark in Finland.

Dr David Eckland, Research and Development Director at Ark, said: "We are working in a breakthrough area of medicine, and acceptance of the Cerepro™ file by the regulatory authorities in Europe is an enormous achievement and the key milestone that we have been seeking for this product. The regulatory authorities have been extremely supportive throughout this process and we look forward to working with them during the review."

Dr Nigel Parker, CEO of Ark, commented: "If the review by the EMEA is successful, CereproTM will be the world's first gene therapy product1. An increasing body of evidence suggests that gene therapy has the potential to deliver solutions for many diseases that are untreatable today and Ark is rapidly becoming recognised as the world leader in this frontier area of medicine."

1 Outside China

A conference call for analysts will be held today at 09.00am BST. For dial in details 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 usually confined to the brain. The current standard therapy involves surgically removing the solid tumour mass (when possible) and initiating radiotherapy and/or chemotherapy. Even with the latest approved treatments, most patients die within one year of diagnosis, with average survival being about eight months. Little therapeutic progress has been made in recent years and the prognosis for malignant glioma patients is poor. A high unmet clinical need exists for new treatments that prolong life in this devastating disease. There are approximately 16,000 cases of malignant glioma in the EU which are operable.


CereproTM is an adenoviral mediated gene based medicine (ad.HSV tk) given by multiple injections into the healthy brain tissue of patients following surgical removal of the solid tumour mass. In the following days, ganciclovir, is given intravenously. Once treated, healthy brain cells surrounding the site where the tumour was removed express the enzyme thymidine kinase. This converts the ganciclovir to a substance which specifically kills dividing cells. The healthy neurones surrounding the tumour in the brain are non-dividing and are therefore not susceptible to this substance. In this way CereproTM harnesses healthy brain cells to help prevent a new tumour from growing.

Ark Therapeutics Group plc

Ark is an emerging healthcare group (the "Group") now entering the commercialisation phase, with one product introduced into hospitals and three further lead products in late stage clinical development. Capitalising on over ten years of research in vascular biology and gene-based medicine, Ark has a balanced portfolio of proprietary healthcare products targeted at specific unmet clinical needs within vascular disease and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues.

Ark's products are sourced from related but largely non-dependent technologies within the Group and have been selected to enable Ark to take each product through development and to benefit from Orphan Drug Status and/or Fast Track Designation, as appropriate. The Group generally retains ownership of its product candidates throughout clinical development. Ark has secured patents or has patent applications pending for all its lead products in principal pharmaceutical markets and retains the right to market its lead products in the key North American and European markets.

Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Mr Stephen Barker of University College London and Professor Seppo Ylä-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland, all of whom play leading roles in the Company's research and development programmes.

Ark's shares were successfully listed through an initial public offering on the London Stock Exchange in March 2004 (AKT.L).

This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.

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