Almac Group’s Integrated Development to Commercialization Services Support Amicus Therapeutics’ First Commercial Orphan Drug Product
August 2, 2016
Craigavon, N.I., UK, – 2 August 2016 – Almac Group, the global contract development and manufacturing organization, wishes to congratulate its long-term client partner, Amicus Therapeutics on the European approval of its first orphan drug product and precision medicine Galafold™ (migalastat, also referred to as AT1001). Galafold was approved as a first line therapy for long-term treatment of adults and adolescents (aged 16 years and older) with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation.
The Almac / Amicus partnership began in 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 Amicus to advance the drug product through scale up, registration and now onwards into commercial supply. Almac is manufacturing and packaging the drug product and supporting Galafold’s launch across Europe from its UK Headquarters in Northern Ireland.
Leveraging the Almac advantage of integrated development and commercial services ensured a smooth transition from development to commercialization for Amicus. Utilizing the experience of Almac’s multidisciplinary product launch team incorporating quality, packaging design, regulatory and distribution, aided Amicus in navigating EU market requirements. Upon marketing authorisation (MA), Galafold was packed and distributed to the German market within hours ensuring patients’ needs were met as quickly as possible.
David Downey, Vice President, Commercial Operations at Almac commented “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 commercialization. Amicus drew upon many of the services Almac has to offer, from development, through clinic, and into commercialization. We look forward to a growing partnership as Amicus services the needs of the Fabry patient population who have an amenable mutation.”
“Providing quality drug product and sufficient drug supply is critical to ensuring a successful launch of Galafold for Fabry patients who have an amenable mutation,” said Enrique Dilone, Ph.D., RAC, Senior Vice President, Technical Operations at Amicus Therapeutics, Inc. “Almac has been an outstanding outsourcing partner for Amicus and we look forward to continuing the relationship as Galafold becomes available across the EU.”
About Almac’s Commercial Services
With over 40 years’ experience and commercial facilities in the UK and US, our global reach and local expertise provides flexible, quality led commercial solutions.
Providing commercial services for new product launches or transferring existing commercial products, we specialize in the scalable manufacture and packaging of solid oral dosage forms from niche orphan drugs to high volume marketed products. Complimented by tailored packaging solutions for sterile, sachet and blister presentations we have supported the launch of multiple orphan drug products over the last 3 years. Value added solutions in artwork/pack design, QP release and 3rd Party Logistics provides end-to-end commercial solutions for our client partners.
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization that has organically grown over 40 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
About Amicus Therapeutics
Amicus Therapeutics is a biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other lysosomal storage disorders.