18 May 2009 - Ark Therapeutics Group plc (‘Ark’ or the ‘Company’) today publishes its interim management statement for the period from 1 January 2009 to date. The Company intends to report its results for the six months to 30 June 2009 on 26 August 2009.
Highlights
• Cerepro® MAA review commenced at the European Medicines Regulatory Agency (“EMEA”)
• Cerepro® Named Patient Supply approved in France and Finland
• Cerepro® Phase III trial update shows results strengthening
• Trinam® awarded Fast Track status by the FDA
• Pre-clinical: multiple gene regulation technology patent filed and progress made in advancing new clinical trials
Clinical Programmes
In January we announced that the Marketing Authorisation Application (“MAA”) for Cerepro®, Ark’s novel gene-based medicine for the treatment of operable glioma, had commenced formal review by the EMEA. Shortly afterwards the French Medicines Control Agency (“AFSSAPS”) approved Cerepro® for Named Patient Supply (“NPS”) and most recently we announced NPS approval in Finland. The first annual update of the results of the Cerepro® Phase III study showed that the main results had strengthened on the primary endpoint (death or re-intervention), and the secondary endpoints were showing increasing support for use of Cerepro®. The EMEA are expected to give an opinion on the MAA in the last quarter of this year.
Following clearance by the FDA in the first quarter to start recruitment into the Trinam® Phase III study, the Company has been engaged in obtaining local regulatory clearances at the investigator sites and training the investigators. Patients have now entered screening and we hope to be able to report the first patient receiving treatment imminently. Earlier this month we announced that the FDA had awarded Fast Track designation to Trinam®, allowing them to work with the Company to expedite the development and review of this important product.
Recruitment of patients into the VitorTM Phase III pilot study in cachexia associated with cancer continues and completion of this pilot study is expected in the second half of 2009. This study is a blinded, randomised, placebo controlled, multi-centre study in up to 64 patients in five countries in Europe.
Pre-clinical Programmes
During the period work has continued in both Finland and London on preparations for bringing the most advanced programmes in the Company’s pre-clinical VEGF gene-based portfolio into the clinic. 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 has been completed. Applications have been made to begin clinical trials in refractory angina and in peripheral vascular disease in conjunction with the AI Virtanen Institute in Finland. Work on final pre-clinical toxicology and GMP manufacture for the foetal growth restriction and VEGF wound healing programmes has also commenced. In the earlier stage pipeline, the Company reported it had filed a patent application relating to a breakthrough small hairpin RNA technology which allows both the up and down regulation of multiple genes, a discovery which illustrates Ark’s ability to operate at the forefront of DNA-based medicine development.
Woundcare
Sales in Ark’s woundcare division have again demonstrated strong growth in the first months of 2009. With another new product identified for launch, we look forward to further progress towards achieving profitability for this business.
Intellectual Property Portfolio
We have continued to prosecute all of our key patents in the period through the international patent prosecution process and contact with the US Patent Office has intensified as it concludes its review of the ‘ACE Stroke’ patent. Detailed preparations for the commercialisation of this patent in both Europe and the USA have been ongoing during the period.
Cash
We reported in our full-year results announcement on 11 March 2009 that the Company had £40.6m in cash and money market investments at 31 December 2008. Cash usage in the business in the period since that date has been in line with the Company’s expectations and, with a continuing focus on managing its resources and cost base carefully, 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 results for the year ended 31 December 2008.
Nigel Parker, CEO of Ark, commented:
“Ark has made good progress in building its business. This is particularly evident with our gene-based products where we are pioneering breakthrough biomedicines for areas of high unmet medical need.
“It is clear that Ark has strengthened its product portfolio as well as its unique manufacturing asset. We remain very focused on using our resources in a way which will enable us to deliver shareholder value.”
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.
