Ark wins French approval for named patient supply of cancer drug

Ark Therapeutics, a specialist healthcare company, has announced that the first named patient supply for Cerepro has been approved by the French Medicines Control Agency following a ‘nominative’ autorization temporaire d’utilisation application made by a neuro-surgeon in France.

Cerepro, Ark’s novel gene-based medicine, is being developed as an orphan drug for the treatment of operable malignant glioma.

An earlier application to make Cerepro available through the autorisation temporaire d’utilisation (ATU) process was denied in France in 2007. Since then Ark has completed Phase III development and has also filed a marketing authorization application (MAA) with the European Healthcare and Medicines Evaluation Agency.

The Phase III study of Cerepro, which completed in July 2008, showed that treatment with Cerepro resulted in a significant therapeutic benefit, supporting the results of the previous Phase II clinical studies.

The MAA for Cerepro was filed by Ark in late 2008 and the company recently announced it had cleared the validation stage. The MAA is now undergoing formal review via the centralized procedure which is the standard route for all advanced therapies.

Nigel Parker, CEO of Ark, said: We are very pleased with this initiative. 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. This is an important milestone and another first for Ark as we believe it is the first time a gene medicine has been approved for use in a named patient supply program in Europe.