PVG.L Regulatory News (PVG)

16 May 2008 07:00



Ark Therapeutics Group plc

Interim Management Statement

16 May 2008 Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its first interim management statement for the period 1 January 2008 to date. The Company intends to report its results for the six months to 30 June 2008 on 27 August 2008.

The overall performance of the business during the period has been in line with the Board's expectations.

Highlights

Timing of Phase III Cerepro® preliminary results confirmed for Q3 2008

Good progress made towards start of Phase III trials for Trinam® and VitorTM 

Acquisition of Lymphatix Oy strengthens gene technology research and secures access to VEGF C and VEGF D genes

Positive opinion letter received from EMEA for Cerepro® Paediatric Investigation Plan

Finnish manufacturing facility completes validation review to USA standards

Ark products win inclusion on new NHS Advanced Woundcare Therapies Contract

Neuropad® in-licensed and launched in the UK

Clinical Programmes

In Cerepro®, the major breakthroughs we achieved in 2007 with the key technical sections of the submission - CMC, pre-clinical and environmental - enable us to contemplate the filing of an application for a full licence once the results of the Phase III corroborative study are available in Q3 2008. In the meantime, work on the Finnish expanded manufacturing facilities, commercial-scale production process and sales and marketing infrastructure have proceeded.

Discussions with the regulators during the period concerning the Phase III trials for Trinam® and VitorTM have remained positive and we anticipate being cleared to start both trials by mid-year. 

Pre-clinical Programmes

The acquisition of Lymphatix Oy in January has enabled us to accelerate our plans for a number of VEGF D-based pre-clinical programmes for which clone selection and planning for toxicity studies are well-advanced.

Woundcare

The good growth seen in our woundcare sales in 2007 has been maintained in the opening months of 2008. The inclusion of Ark's products on the new NHS Advanced Woundcare Therapies Contract and the recent launch of Neuropad® give us further confidence for the future success of this business.

Intellectual Property Portfolio

We have made continued progress in taking our key patents through the international prosecution process. Further progress has been made towards the commercialisation of the 'ACE Stroke' patent and the Company continues to receive enquiries concerning licensing of other intellectual property in Ark's portfolio.

Cash

As we reported in our 2007 annual results announcement, the Company had £65.1m in cash and money market investments at 31 December 2007. Cash usage in the business in the opening months of 2008 has been in line with the Board's expectations and Ark remains well-funded to build on its leading position in the gene therapy area. There have been no other significant changes in the position of the Company over the period since publication of the report and accounts for the year ended 31 December 2007. 

Nigel Parker, CEO of Ark, commented:

"The progress achieved in our business in 2007 has continued in the opening months of this year. In our three late-stage clinical programmes, Cerepro® Phase III trial results have been confirmed for the third quarter and progress has been made towards starting the Phase III trials for Trinam® and VitorTM. We have commenced work to bring a number of our pre-clinical programmes through the late stage pre-clinical work prior to taking three of them into Phase I trials. I am delighted that the sales growth in our woundcare business reported in our 2007 annual results has been maintained in the period. With our broad range of products and strong cash position, we are well placed to continue meeting the objectives we have set."

Enquiries

Notes to Editors

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, wound care and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues. With four marketed devices, Kerraboot®, Kerraped®, Flaminal® and Neuropad®, and three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam®, the Group is transitioning from an R&D company to a commercial, revenue generating business.

Ark's own products are sourced from related but largely non-dependent technologies within the Group and have been selected to enable them to be taken through development within the Group's own means and to benefit from Orphan Drug Status and/or Fast Track Designation, as appropriate. This strategy has allowed the Group to retain greater value and greater control of clinical development timelines, and to mitigate the risks of dependency on any one particular programme or development partner. Ark has secured patents or has patent applications pending for all its lead products in principal pharmaceutical 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 first listed 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.