13 Jul 2010 07:00
ARK UPDATE AND BOARD CHANGES
London, UK, 13 July 2010: Ark Therapeutics Group plc ("Ark" or the "Company") provides an update on progress since the publication of the interim management statement on 18 May.
STRATEGIC REVIEW
As reported on 18 May, the Board endorsed a strategy of selective partnering of programmes together with a plan to monetise certain assets through continuing discussions with parties that had expressed an interest in discrete parts of the business, in particular the Woundcare business and Manufacturing.
A number of companies have completed or are in the process of completing due diligence on the Group's Woundcare business and negotiations are now in progress with a number of those companies. A further announcement on this will be made as soon as possible.
Optimisation of the manufacturing facility's use and value is to be achieved through increasing the scale of contract manufacturing capacity and by entering into more formal collaborative partnerships. Detailed discussions with selected companies on a more strategic partnership are in progress and a growing number of companies are now in discussions for manufacturing services.
Furthermore, the Board has concluded that all available options for increasing shareholder value should be explored and is pleased to announce the appointment of Iain Ross as a consultant to the Company. Iain will work in a part-time role to support Martyn Williams and his management team in identifying and implementing the strategic initiatives required to restore shareholder value including working on manufacturing, commercial and funding initiatives and options. Further, the Board is pleased to announce that Iain has also accepted its invitation to join the Board as a Non-Executive Director, subject to the prior approval of shareholders. The Company remains, at the present time, in an offer period, and as such is subject to the rules of the Takeover Code. Accordingly, the appointment of Iain Ross to the Board, and the terms of a formal consultancy agreement under which he will provide services to the Company, are conditional upon and subject to the approval of shareholders at a general meeting. A circular will be posted to shareholders shortly, containing the notice of the general meeting which the Company expects will be held by mid-August. Until such time as the formal consultancy agreement has been approved by shareholders, Iain Ross has been retained on an 'at will' basis with immediate effect. Further biographical details are set out below.
In addition the Group has put in place an ongoing review of costs by activity to ensure that savings can be identified as early as possible with the aim of extending the current cash 'runway' beyond the end of 2011.
The Company remains in an offer period until all approaches made to the Company have been finally resolved. Until such time there can be no assurances that any such approach will lead to an offer.
KEY PROGRAMMES
Cerepro®
Following a meeting with the FDA in early June, they have informed the Company that they will require an additional trial before accepting Cerepro® for review. The FDA confirmed that the pre-clinical package was, in principle, acceptable. Implementation of a detailed plan to seek a partner to finance a further trial of Cerepro® to meet EMA and FDA requirements has commenced with the aid of an experienced out-licensing consultant.
Trinam®
Recruitment of patients into this trial is proving very difficult, due in part to a total focus in the Company on Cerepro® in the first quarter of 2010. A series of intensive remedial actions have been undertaken, leading to a recent increase in patients entering screening. Management is working closely with all the investigators to accelerate recruitment. In addition, one experienced clinical centre in a second country will be opened to accelerate the trial recruitment in parallel to the US centres.
EG011 Refractory Angina
The 30 patient Phase I/IIa study with AI Virtanen Institute is making good progress. So far no adverse events have been reported and an initial readout from the 10 patients in the dose ascending part of the study is expected by the end of the year. Partnering interest has already been received by the Company in respect of this programme.
EG016 Peripheral Vascular Disease
The Phase I/IIa study with the AI Virtanen Institute in up to 30 patients suffering from chronic lower limb ischaemia is in process with a 'mid-term' evaluation of the dose ranging part of the study due in H2 2010. The Company will consider partnering the product after the current study.
EG014 Neuropilin 1 (NP-1)
The product comprises small molecule antagonists which have been shown to reduce significantly tumour growth in a pre-clinical in vivo cancer model. Following the announcement on 12 April of positive in vivo results, a repeat study has demonstrated similar reductions in tumour size. One of the major pharma companies which have expressed interest in this programme has requested early access to one of our compounds. Other currently marketed products given intravenously have established a large clinical need for products such as Ark's NP-1 antagonists, which have the added advantage of three anti-cancer modes of action in conjunction with a small molecule approach.
EG013 Foetal Growth Restriction (FGR)
Good progress continues to be made in studies of pre-clinical models of FGR, preliminary toxicology studies and ex vivo studies of the human placenta. The Company plans to commence clinical studies in H1 2012.
ACE IP
As previously announced, the European Patent Office upheld the Opposition to this patent in Europe. On advice from the Company's legal advisors that the decision is contrary to existing case law of the EPO boards of appeal, the Company will file an appeal.
Following a positive meeting with the US Patent Office in June, the Company believes it is in the final stages of patent prosecution. Grant of the patent in the USA will trigger a further milestone payment to the Company under its agreement with Boehringer Ingelheim and will also enable further exploitation of this intellectual property.
BOARD CHANGES
Dr Wolfgang Plischke and Sir Mark Richmond will step down from the Board after many years following the August Board meeting. Both have contributed greatly to Ark's development and they will be missed. The Company is very pleased to announce the agreement of Iain Ross to join the Board, conditional upon shareholder approval. If such approval is obtained, Iain will join as a Non-Executive Director, but has also agreed to work in a part-time role, with immediate effect, as described above.
Following a career with multi-national companies including Sandoz, Fisons plc and Hoffman La Roche, Mr Ross joined the Board of Celltech Group plc in 1991 and was responsible for building Celltech Biologics, the contract manufacturing division which was later sold to Alusuisse Lonza. For the last 15 years he has undertaken a number of company turnarounds and start-ups as a board member on behalf of private equity groups and banks including Quadrant Healthcare plc, Allergy Therapeutics Ltd, Eden Biodesign Ltd, Phadia AB and SR Pharma plc. Currently he is Non-Executive Chairman of Biomer Technology Ltd and Pharminox Ltd, and is a Non-Executive Director of Benitec Limited. He is a Qualified Chartered Director of the UK Institute of Directors; a Trustee of the Breast Cancer Haven and a member of the Council of Royal Holloway University of London.
In accordance with Listing Rule 9.6.13, the following information is disclosable:
In the past five years, Iain Ross has held directorships of Silence Therapeutics plc (formerly SR Pharma plc), Angle plc and Hansard Group plc, whose shares were traded on the London Stock Exchange. Mr Ross is currently a Director of Benitec Limited, whose shares are traded on the Australian Securities Exchange (ASX).
The Company confirms that there is no further information to disclose in relation to Listing Rule 9.6.13.
A copy of this announcement is available at the Company's website www.arktherapeutics.com.
For further information:
Ark Therapeutics Group plc | Tel: + 44 (0)20 7388 7722 |
Martyn Williams, CEO | |
Andrew Christie, Chairman | |
| | |
Financial Dynamics | Tel: +44 (0)20 7831 3113 |
Ben Atwell | |
Susan Quigley | |
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® 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.