ARK fails to get MAA for Cerepro
Today Ark released the negative opinion of EMEA for it's crucial Cerepro- drug.
ARK
Ark turns to CMO
Ark Therapeutics is using its expertise and spare capacity to move into the contract manufacturing sector and is hoping to sign deals to produce the DNA-based medicine.
Innovator companies are increasingly offering contract services or manufacturing to provide an additional source of revenue, make potentially important contacts in the industry and help develop in-house knowledge and expertise.
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Ark Therapeutics gets approval for named patients use in Finland
Ark Therapeutics, an Anglo-Finnish company announced that its was granted a permission to supply it's gene therapy drug Cerepro to named patients in Finland. Previously the company had obtained a similar approval for named patients in France after a submission by a local neurosurgeon.
Ark is expected to receive MAA decision from EMEA later this year and possibly become a first company to market gene therapy drugs in EU:
France Gives First Approval For Named Patient Supply Of Cerepro(R)
Ark Therapeutics Group plc ("Ark" or the "Company") (AKT:LSE) today 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.
