Ark Therapeutics, the AIM-listed pharmaceuticals group, said yesterday that it would consider offers for the company after its potential brain cancer treatment, Cerepro, was rejected by European regulators.
The European Medicines Agency's oncology advisory group refused to reverse a decision it made last December, when it said that the drug did not sufficiently demonstrate that patients gained any clinical benefit after using Cerepro. Nigel Parker, Ark's chief executive, insisted that the drug had showed a 20 per cent survival rate improvement.
The treatment, intended for high grade glioma, is the first gene-based medicine considered for approval by European regulators. The drug failed its third and final trial, after tumours reoccurred in patients who had earlier been treated.
"We are naturally disappointed with the news," said Dr Parker. "Whilst there are differences of opinion concerning the data relating to the reintervention 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."
Ark has withdrawn Cerepro, on the advice that it would require a further costly clinical trial. The group said yesterday that it "has initiated a full review of its substantial portfolio of assets, their potential and alternative strategies and options to optimise shareholder value".
Ark is now expected to consider approaches for the company, or seek a licensing deal, to help pay for the next stage of research. However, any potential sale price is likely to have suffered as a result of yesterday's decision.
Alternatively, the group could opt to fund any further clinical trial itself, asking shareholders for money through a rights issue. Ark's cash position is likely to be revealed today when the group publishes its preliminary results.
Ark's shares fell by 13 per cent yesterday, to close at 12p.Reuse content