13 November 2008 - Ark Therapeutics Group plc (‘Ark’ or the ‘Company’) today publishes its interim management statement for the period 1 July 2008 to date, including an update of the Company’s operations since the interim results announced on 27 August 2008.
Highlights
• Cerepro® Phase III trial achieves significance on primary endpoint
• Patient enrolment into VitorTM Phase III pilot study commenced
• New GMP manufacturing facility opened in Finland
• Positive feedback received from EMEA Gene Therapy Working Party on EG013 for foetal growth restriction pre-clinical toxicology and Phase I development
• Launch of Neuropad® and Kerramax® following reimbursement approval by the UK NHS Business Services Authority
Clinical Programmes
In July we announced that preliminary analysis of the results of the Cerepro® Phase III study in operable malignant glioma (Study 904) showed that the trial reached significance on the primary endpoint. Further data presented by study investigators at the European Association of Neuro-oncology in Barcelona in September confirmed that the demographics of the patients in the active and control groups were well matched. As the lead investigator commented, the data will mature as the remaining 45% of patients still alive reach their trial end points. An update of the results will be available in the first quarter of 2009. Following an initial meeting with the EMEA rapporteur, the Company plans to file an application for marketing approval in Q4 2008. Commercial supply production remains ongoing and the opening of our expanded manufacturing facilities in Finland in the period will allow Ark to be self-sufficient for the manufacture of all its gene-based products in its portfolio.
We announced the commencement of recruitment of patients into the VitorTM Phase III pilot study in cachexia associated with cancer. This study is a blinded, randomised, placebo controlled, multi-centre study in up to 64 patients in five countries in Europe. Full Phase III development is expected to commence, following successful completion of this pilot study in the second half of 2009.
Following Special Protocol Assessment approval of Trinam®’s Phase III study, scientific work requested by the IND assessor to qualify one potency batch release assay has progressed to a late stage and the Company has started to set up the clinical trial sites in the USA. We expect to be cleared for patient recruitment before the end of the year once the assay work is completed.
Pre-clinical Programmes
Work has continued during the period in Finland and London on the Company’s pre-clinical VEGF gene-based portfolio. These programmes are all based on our successful adenoviral delivery technology where we are optimising the gene to the disease in this second generation of gene-based medicines. Manufacture of GMP material for a refractory angina (EG011) clinical trial commenced; a positive meeting was held with the EMEA Gene Therapy Working Party to agree the pre-clinical toxicology and Phase I trial for EG013, a treatment for foetal growth restriction; progress has been made to accelerate the VEGF wound healing programme towards Phase I.
Woundcare
We reported a 68% increase in woundcare sales to £0.4m in the first six months of 2008, compared with the same period in 2007. In the second half of this year to date, this rate of growth increased and, with the reimbursement approval and launch of two further products in Q4, Neuropad® and Kerramax®, we expect further growth.
Intellectual Property Portfolio
We have made continued progress in taking our key patents through the international patent prosecution process, and have confirmation of expedited review by the US Patent Office of the ‘ACE Stroke’ patent. The appointment of a new Commercial Development Director with significant experience in this area is giving further impetus to the commercialisation of this patent. The Company continues to receive enquiries concerning licensing of other intellectual property in Ark’s portfolio.
Cash
As we reported in our interim results announcement on 27 August 2008, the Company had £50.5m in cash and money market investments at 30 June 2008. Cash usage in the business in the period since that date has been in line with the Company’s expectations and Ark remains well-funded to make continued progress in its lead clinical and pre-clinical programmes. There have been no other significant changes in the position of the Company over the period since publication of the interim results for the six months ended 30 June 2008.
Nigel Parker, CEO of Ark, commented:
“The progress achieved in our business during the first half of 2008 has been continued during this period. We have had successful dialogue with regulators at all levels of product development and whilst much attention is, understandably, focused on Cerepro® we have made progress throughout the Company to build value in breadth and depth, whilst at the same time managing our costs. With our broad range of products and strong cash position, we are well placed to continue meeting the objectives we have set.”
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 five marketed devices, Kerraboot®, Kerraped®, Flaminal®, Neuropad® and Kerramax® 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 both 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, where 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.
