PVG.L Regulatory News (PVG)

11 Nov 2009 07:00



Ark Therapeutics Group plc

Interim Management Statement

11 November 2009 - Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its interim management statement for the period from 1 July 2009 to date, including an update of the Company's operations since the interim results announced on 26 August 2009. 

Highlights

Key Programmes

On 22 October further Cerepro® Phase III results were presented by one of the principal investigators for the study at the Society of Neuro-oncologists in New Orleans. There was considerable interest from medical professionals attending the conference with more than 200 attending Ark's satellite symposium. The EMEA's review of the Company's Marketing Authorisation Application has continued in the period and an opinion is still expected by the end of the year.

Late in the first half of the year we reported the recruitment of the first patient into the Trinam® US Phase III study. Following clearance of a technical manufacturing issue, efforts have been concentrated on site initiations and training of investigators in the procedure. With the recent regulatory clearance of the key opinion leader and Principal Investigator's site for patient recruitment and an increased number of sites now open, it is anticipated that enrolment will accelerate.

Recruitment of patients into the VitorTM Phase III pilot study in cachexia associated with cancer continues and, as stated at the time of the half-year results' announcement, despite a slower rate of recruitment than planned, an interim report on the study is expected before the end of the year. 

Following the approval in late August from the Finnish National Agency for Medicines to start a Phase I/IIa trial in refractory angina (EG011) in collaboration with the AIV Institute in Finland, preparations for patient recruitment have progressed well and a number of patients are now in screening.

Woundcare

Sales of Ark's woundcare products have continued the period on period growth reported in the half-year results and, with Kerraglove® now launched, we look forward to maintaining this growth towards sustainable profitability for these products.

Intellectual Property Portfolio

We have continued to progress the realisation of value from our stroke patent in Europe with the clarification of the timetable for legal resolution. Pivotal hearings are now scheduled for next year. In the USA, no office actions are outstanding and we understand the grant of the ACE stroke patent is only delayed by the current general processing difficulties in the US Patent Office.

Manufacturing

Validation of the new manufacturing facility in Kuopio has proceeded according to plan. At the same time the initial phase of the manufacturing contract with Oy LX Therapies Ltd has been completed successfully and the Company is in late stage contract discussions with two further gene medicine companies which have approached Ark with a view to our undertaking their GMP manufacturing. 

Cash

We reported in our half-year results' announcement on 26 August 2009 that the Company had £28.6m in cash and money market investments at 30 June 2009. Since that date cash consumption in the business has been in line with the Board's expectations as the Company continues to manage its resources and cost base carefully. The Board reviews detailed cash forecasts on a regular basis, which take into account a number of scenarios associated with product development and commercialisation, and remains satisfied with the current financial position of the Company. There have been no other significant changes in the position of the Company over the period since publication of the results for the six months ended 30 June 2009.

Nigel Parker, CEO of Ark, commented:

"The theme of our half-year results' announcement was 'Pioneering essential biomedicines'. Progress in the period since then has served to reinforce this statement not only with the positive response by clinicians to the latest published Cerepro® data but also in all other areas of our business. We continue to maintain our focus to advance the clinical development of products for serious unmet clinical need where DNA-based biologics offer the most logical treatment solution." 

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 six marketed devices, Kerraboot®, Kerraped®, Flaminal®, Neuropad®, KerraMax® and Kerraglove®, three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam® and two in Phase I/IIa trials, EG011 and EG016 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.