Almac Group’s long-term client partner, Wellstat Therapeutics, received commercial approval of its first orphan drug product XURIDEN (uridine triacetate) for the treatment of rare disease Hereditary Orotic Aciduria (HOA).

The partnership began five years ago with Almac providing support for the development of both the API and formulation of the drug product. Having manufactured clinical, registration and PV batches, Almac will now produce the commercial product from its UK headquarter facilities, on behalf of Wellstat Therapeutics.

Following a successful Pre-Approval Inspection (PAI) of Almac’s UK facilities in May of this year and the subsequent FDA approval of the product on September 4, 2015, XURIDEN will be commercially available in early 2016.

David Downey and Charles Shields, vice presidents of Almac’s Drug Product and API teams respectively, said “It is great to see a product that Almac has supported long term in both development of the API and Drug Product achieve commercial approval. The value of integrating development and the flexibility it offers our partners cannot be overstated.”
“Until FDA approval of XURIDEN, there were no approved treatments for patients with hereditary orotic aciduria, a rare, potentially life-threatening disease”, said Michael Bamat, vice president R&D for Wellstat Therapeutics. “Almac has been an integral part of the API and drug product development team for XURIDEN.”