Galafold has received European regulatory approval
Almac is manufacturing and packaging Galafold, which has been approved by the European regulator
Almac Group, a global contract development and manufacturing organisation, will manufacture and package a new drug for treating Fabry disease, which has been developed by Amicus Therapeutics.
Galafold (migalasat, also referred to as AT1001), was approved by the European regulator on 22 May as an orphan drug for treating adults and adolescents aged 16 and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation.
Almac will manufacture and package the drug product and support the launch of Galafold across Europe from its UK headquarters in Craigavon, Northern Ireland.
Almac and Amicus have been partners since 2009 when Amicus sought an outsourcing partner for Phase III clinical manufacture and packaging of its solid oral AT1001 compound.
Almac’s pharmaceutical development and clinical teams worked with the firm to progess the drug product through scale up, registration and now into commercial supply.
The Irish CDMO said its integrated development and commercial services ensured a smooth transition from development to commercialisation.
Upon receiving marketing authorisation, Galafold was packed and distributed to the German market within hours, ensuring patients’ needs were met quickly, said Almac.
David Downey, Vice President, Commercial Operations at Almac, said: 'It’s great to see the launch of this precision medicine addressing a debilitating unmet medical need and it is gratifying to have played our part in its development and commercialisation.'