March 9, 2010: Ark Therapeutics Group plc has 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. Ark has therefore withdrawn from the current MAA process to examine this recommendation.
Despite the use of a blinded re-intervention committee and the Phase 3 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. Ark was advised that it must conduct a further study which would need to be powered to show a benefit on an endpoint that 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 portfolio of assets 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.
Ark 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 is no certainty that an offer will be made for the company. Ark is therefore deemed to be in an Offer Period for the purposes of the Takeover Code.
