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Almac Group’s Integrated CMC Services Support US Approval of Wellstat Therapeutics’ First Commercial Orphan Drug Product

Published 28 September 2015 | By Almac

Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long term client partner Wellstat Therapeutics on the commercial approval of their first orphan drug product XURIDEN™ (uridine triacetate). XURIDEN has been developed as a treatment for the rare disease Hereditary Orotic Aciduria (HOA).

The partnership began more than 5 years ago with Almac's Sciences and Pharma Services business units providing expert support to Wellstat Therapeutics for the development of both the Active Pharmaceutical Ingredient (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 is forecast to be commercially available in early 2016.

Leveraging Almac's unique integrated API and Drug Product expertise prior to and through NDA submission and approval, Wellstat Therapeutics worked with Almac to take advantage of a single partner approach with smooth transition through the drug development process and now commercialisation, saving time, transfers and other uncertainties inherent in a multi-supplier process.

David Downey and Charles Shields, VP's of Almac's Drug Product and API teams respectively commented "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, VP Research & Development for Wellstat Therapeutics. "Almac has been an integral part of the API and drug product development team for XURIDEN."