The Board of Ark Therapeutics Group plc announced 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 The company has therefore withdrawn from the current MAA process to examine this recommendation.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 one pence each in issue. The International Securities Identification number for the ordinary shares is GB0034251727.
Ark Therapeutics Group plc is a specialist healthcare group addressing high value areas of unmet medical need within vascular disease, wound care and cancer.