Ark Therapeutics Group plc (Ark) announces that the first Named Patient Supply (NPS) for Cerepro has been approved by the French Medicines Control Agency (AFSSAPS) following a 'nominative' ATU application (Autorisation Temporaire d'Utilisation) made by a neuro-surgeon in France. Cerepro (sitimagene ceradenovec), Ark's novel gene-based medicine, is being developed as an Orphan Drug for the treatment of operable malignant glioma.
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.
An earlier application to make Cerepro available through the ATU process was denied in France in 2007. Since then Ark has completed phase-III development and has also filed a Marketing Authorisation Application (MAA) with the European Healthcare and Medicines Evaluation Agency (EMEA).
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 centralised procedure which is the standard route for all advanced therapies.
Dr David Eckland, R&D director of Ark commented, "Cerepro consistently demonstrates clinical benefits in trials and represents a much needed treatment for operable glioma. 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. The decision to approve on a Named Patient Supply demonstrates the increasing recognition of the utility of the product as well as the confidence amongst the neuro-surgeon community to use it."
Dr 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 programme in Europe."
Ark Therapeutics Group plc is a specialist healthcare group addressing high value areas of unmet medical need within vascular disease, wound care and cancer.