Ark Thera slumps as it withdraws Cerepro MAA and looks at 'strategic options'

UK-based Ark Therapeutics' stock tumbled 11.1% yesterday, after the company said it was withdrawing its European filing for its brain cancer drug Cerepro (sitimagene ceradenovec) and considering its options for the future, including a possible sale of the business.

Ark saw its share price plummet 50% to 15 pence on December 18, after a negative opinion from European regulators, recommending that its Cerepro should not be granted a marketing authorization (The Pharma Letter December 21, 2009).

Yesterday, Ark said that, following a presentation to the European Medicines Agency's (EMEA) 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. As a result, Ark has withdrawn from the current marketing approval process to examine this recommendation.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 tumor recurrence was made by the individual neurosurgeon on a case by case basis and thus there was no standardized 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 authorization, Ark explained.