ARK UPDATE AND BOARD CHANGES
13 July 2010 - 4:00PM
UK Regulatory
TIDMAKT
RNS Number : 2299P
Ark Therapeutics Group PLC
13 July 2010
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(TM), 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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