Ark withdraws Cerepro® MAA after SAG-O requests further trial before approval
Company to undertake strategic review of business
London, UK, 9 March 2010: The Board of Ark Therapeutics Group plc ("Ark" or "the Company") today announces an update relating to the Marketing Authorisation Application ("MAA") for its brain cancer treatment, Cerepro®. Following a presentation to the EMEA's Scientific Advisory Group on Oncology ("SAG-O") as part of the re-examination procedure, the SAG-O did not consider that the current study provides sufficiently reliable evidence of clinical benefit. The recommendation was made that the Company needed to conduct a further clinical trial before the product could be approved. The Company has therefore withdrawn from the current MAA process to examine this recommendation.
The SAG-O did not consider that the current study provides sufficiently reliable evidence of clinical benefit. The decision to re-intervene following tumour recurrence was made by the individual neurosurgeon on a case by case basis and thus there was no standardised decision making. Therefore, despite the use of a blinded re-intervention committee and the Phase III data showing no evidence of bias on all available re-intervention related study measurements, the SAG-O advised that the data on the primary endpoint could not be considered reliable and therefore did not provide appropriate evidence of a therapeutic benefit for a marketing authorisation. The Company was advised that it must conduct a further study which would need to be powered to show a benefit on an endpoint which was or could be established as clinically and statistically robust.
Following the withdrawal of the Cerepro® MAA, Ark has initiated a full review of its substantial portfolio of assets, their potential and alternative strategies and options to optimise shareholder value. The review will also consider strategic alternatives in light of approaches that have already been received.
The Company has received a number of approaches and has initiated further discussions with a number of parties which may or may not lead to an offer being made for the Company. However, there can be no certainty that an offer will be made for the Company. A further announcement will be made in due course.
Ark is therefore deemed to be in an Offer Period for the purposes of the Takeover Code.
Nigel Parker, CEO at Ark, commented "We are naturally disappointed with this news. Throughout Cerepro®'s development we have worked with eminent glioma experts and neurosurgeons, a number of whom have supported and represented us in the MAA review process. Whilst there are differences of opinion concerning the data relating to the re-intervention endpoint, we are in a unique position with all the barriers in relation to approval of the gene medicine components of Cerepro® behind us and the recommendation for a further trial to resolve outstanding concerns is the logical way forward to secure marketing approval. "
In accordance with Rule 2.10 of the City Code on Takeovers and Mergers, the Company announces that it has 208,756,751 ordinary shares of 1 pence each in issue. The International Securities Identification number for the ordinary shares is GB0034251727.
Nigel Parker, CEO, and Martyn Williams, CFO, will host an analyst/investor conference call today at 11.30am GMT. For further details please contact Mo Noonan at Financial Dynamics on 44 (0)20 7269 7116.
Ark Therapeutics Group plc
Chief Executive Officer
020 7388 7722
Chief Financial Officer and Company Secretary
020 7831 3113
Piper Jaffray Ltd
020 3142 8700
Credit Suisse Securities (Europe) Limited
020 7888 8888
Piper Jaffray Ltd. ("Piper Jaffray"), which is authorised and regulated by the Financial Services Authority, is acting exclusively for Ark and for no-one else in connection with the matters referred to in this announcement and will not be responsible to anyone other than Ark for providing the protections afforded to customers of Piper Jaffray nor for giving advice in relation to the matters referred to in this announcement.
Credit Suisse Securities (Europe) Limited ('Credit Suisse'), which is authorised and regulated by the Financial Services Authority in the United Kingdom, is acting for Ark Therapeutics and for no one else in connection with the matters referred to in this announcement and will not be responsible to any person other than Ark Therapeutics for providing the protections afforded to clients of Credit Suisse, nor for providing advice in relation to the matters referred to in this announcement, the content of this announcement or any matter referred to herein. Neither Credit Suisse nor any of its subsidiaries, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Credit Suisse in connection with this announcement, any statement contained herein or otherwise.
Dealing Disclosure Requirements
Under the provisions of Rule 8.3 of the City Code on Takeovers and Mergers (the "Code"), if any person is, or becomes, "interested" (directly or indirectly) in 1% or more of any class of "relevant securities" of Ark, all "dealings" in any " relevant securities" of Ark (including by means of an option in respect of, or a derivative referenced to, any such "relevant securities") must be publicly disclosed by no later than 3.30 pm (London time) on the London business day following the date of the relevant transaction. This requirement will continue until the date on which the offer becomes, or is declared, unconditional as to acceptances, lapses or is otherwise withdrawn or on which the "offer period" otherwise ends. If two or more persons act together pursuant to an agreement or understanding, whether formal or informal, to acquire an "interest" in "relevant securities" of Ark, they will be deemed to be a single person for the purpose of Rule 8.3.
Under the provisions of Rule 8.1 of the Code, all "dealings" in "relevant securities" of Ark by Ark or by any of its "associates", must be disclosed by no later than 12.00 noon (London time) on the London business day following the date of the relevant transaction.
A disclosure table, giving details of the companies in whose "relevant securities" "dealings" should be disclosed, and the number of such securities in issue, can be found on the Takeover Panel's website at www.thetakeoverpanel.org.uk.
"Interests in securities" arise, in summary, when a person has long economic exposure, whether conditional or absolute, to changes in the price of securities. In particular, a person will be treated as having an "interest" by virtue of the ownership or control of securities, or by virtue of any option in respect of, or derivative referenced to, securities.
Terms in quotation marks are defined in the Code, which can also be found on the Panel's website. If you are in any doubt as to whether or not you are required to disclose a "dealing" under Rule 8, you should consult the Panel.
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®, KerraMax®, Kerraglove®, Flaminal® and Neuropad®, and three further lead pharmaceutical products in late stage clinical development: Cerepro®, VitorTM 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 Yla-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).