PVG.L Regulatory News (PVG)

28 Jan 2010 07:00



Ark announces re-prioritisation of 

programmes and implementation of restructuring following filing of request for reassessment of Cerepro® Marketing Authorisation Application

- Cost cutting implemented

- Vitor™ put on hold

London, UK, 28 January 2010 - Further to the announcement by Ark Therapeutics Group plc ('Ark' or the 'Company') on 18 December 2009 where it was highlighted that the Company would undertake actions to reduce its cost base as a consequence of the longer Cerepro® MAA approval timeframe, Ark can confirm today that it has implemented a series of restructuring measures to extend its cash runway.

The Company has begun consultations with employee representatives on headcount reductions in manufacturing, research and development and support staff, as well as reducing investment in non-core early stage research programmes. In addition, after first pilot trial results show a change in its trial design is required, Ark has decided to put the development of VitorTM on hold.

The current review has focused on the need to continue the development of the Company's key strategic assets - principally, the gene-based medicine business with its fully developed adenoviral platform, the recognised biologics manufacturing capability and licensed facility in Kuopio, IP and "stroke" patents - and its rapidly growing wound care business.

As part of this restructuring programme and after first pilot trial results show a change in its trial design is required, Ark has decided to put the development of VitorTM on hold. The interim analysis of the first 22 patients with non small cell lung cancer (NSCLC) entered into the pilot Phase III study for VitorTM, a lipophylic ACE inhibitor under development to prevent involuntary weight loss (cachexia) associated with cancer, showed no weight loss in either the treatment or the control groups in the 12 week treatment period. It was therefore not possible to ascertain any treatment effect on weight loss using this trial design.

The pilot Phase III trial, was a randomised, placebo controlled study in up to 60 patients conducted after initial Special Protocol Assessment discussions with the FDA. Its design differed from the previous Phase IIb/III study, in terms of the introduction of a 2-6 week study run in period, controlling for the disease state and chemotherapies used and the way cachexia endpoints were precisely measured. Due to the variability of cancer, and the ways individual patients respond to different chemotherapies, the study was rigorously controlled to ensure a consistent study population, so neither disease stage, nor active cancer treatment, nor end point measurement techniques were likely to influence the results.

As a result, the Company's operational focus will be on completing Cerepro® and Trinam® programmes and ensuring the key pre-clinical programmes in refractory angina (EG011), (see separate announcement today) peripheral vascular disease (EG016) and foetal growth retardation (EG013) progess in Phase I/IIa development. The measures currently being implemented should mean that the Company's current cash will fund its operations into the second half of 2011.

Commenting on the restructuring measures, Martyn Williams, CFO at Ark, said: "With the delay announced in December, it is sensible to take steps now to ensure we have a longer cash horizon and can protect the core assets of the business in order to hit the crucial value-creating milestones. We have had to make some very difficult and painful decisions, especially those which affect our employees, all of whom have played a part in delivering the progress Ark has made to date."

Commenting on VitorTM, David Eckland, Director of R&D at Ark, commented: "In recruiting this very tightly controlled trial, it seems that whilst the study treatment population exhibited weight loss early in the disease and in the run-in period, they have then entered a period of stability where progressive weight loss is not present. We need to do further analyses on these patients to understand more, but to go forward we will need to modify the trial design and entry criteria in conjunction with experts and the regulators."

Dr Nigel Parker, CEO, added: "We have developed world class expertise in gene therapy and a unique manufacturing and development product portfolio. The success with the technical aspects of Cerepro® and particularly the establishment of an approvable adenoviral gene medicine platform have allowed us to take these measures without significantly impacting our future gene medicine business, short to medium term. Taking these measures has been painful to us but we are confident of our success in this exciting and valuable new area of medicine."

For further information:

Notes to Editors

About 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.