Ark Therapeutics is in talks about a possible sale of the company after European regulators informed the UK firm that an expensive additional clinical trial is needed before its brain cancer drug Cerepro could be given the green light.

Ark has withdrawn its marketing authorisation application after a presentation to the European Medicines Agency's Scientific Advisory Group on Oncology failed to bring about a reversal of a negative decision issued in December on Cerepro, its gene-based therapy for operable malignant glioma. The EMA still does not think the current study “provides sufficiently reliable evidence of clinical benefit” and is demanding another trial.

The London-headquartered company has now initiated “a full review of its substantial portfolio of assets, their potential and alternative strategies and options to optimise shareholder value”. Specifically Ark said it will also consider “strategic alternatives in light of approaches that have already been received’.

Indeed the firm added that it has initiated “further discussions with a number of parties” and is therefore deemed to be in an ‘offer period’ for the purposes of the UK’s Takeover Code.

Chief executive Nigel Parker was surprisingly upbeat, noting that while “we are naturally disappointed with this news”, he feels Cerepro still has a future. He added that throughout development of the drug, “we have worked with eminent glioma experts and neurosurgeons, a number of whom have supported and represented us in the MAA review process”.

Mr Parker added that while there are “differences of opinion concerning the data…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”.

Robin Davison, an analyst at Edison Investment Research, told PharmaTimes World News that Ark is worth between £21-£24 million and needs to work out both a regulatory strategy for Cerepro, ideally one that would satisfy both the EMA and the US Food and Drug Administration, and a business plan. The problem it initially has is financing a trial that would have sufficient number of patients, something that would take a long time and cost “easily £20 million”.

The amount of patients for whom Cerepro would be an option is pretty small (there are 16,000 cases of malignant glioma in the EU which are operable) so Mr Davison feels that it is too small a market for big pharma to think about buying Ark, though a specialty pharma company could be interested. He told PharmaTimes World News that saying it has had approaches could flush out other suitors for the firm, but he believes Oxford BioMedica, another UK-based gene therapy specialist, would be a good fit.

He concluded by saying that regulators feel they could be “opening Pandora’s Box on gene therapy” if they grant approvals for treatments which have simply not been used on many patients.