The approval allows London-based Ark to ship the product, Cerepro, to any French surgeon who asks for it, and implies that the Phase III data file, currently under scrutiny by the European Medicines Control Agency, EMEA, will be sufficient for approval.
An earlier request by the same neurosurgeon was turned down at a time when only the Phase II data was available, but Affsaps, the French regulator, will have had access to the Phase III trial when considering the subsequent request for an ATU.
Named patient supply through the ATU process in France is granted on an exceptional and temporary basis, for the use of a medicinal product without a marketing authorisation in the treatment, prevention or diagnosis of serious or rare diseases where no suitable therapeutic alternative exists and when the benefit/risk ratio of the medicinal product is presumed positive.
The earlier application to make Cerepro available through the ATU process was denied in 2007. Since then Ark has completed Phase III development and filed a marketing application with EMEA.
David Eckland, R&D Director of Ark, said Cerepro represents a much-needed treatment for brain cancer. “Ark is now receiving an increasing number of requests to treat patients with Cerepro and we are delighted that this first approval has been given in France.”
Nigel Parker, CEO of Ark, said, “There remains a significant unmet need in patients with malignant glioma and approval on a named patient basis is a logical step to making the product more widely available.”
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