Almac, Wellstate in Commercial Supply PactBy
The Almac Group, a contract development and manufacturing organization, will provide commercial quantities of a recently approved orphan drug, Xuriden (uridine triacetate), by Wellstat Therapeutics, a biopharmaceutical company based in Gaithersburg, Maryland. Earlier this month, the US Food and Drug Administration approved Xuriden for treating hereditary orotic aciduria, a rare metabolic disorder, which has been reported in approximately 20 patients worldwide.
Wellstat anticipates that Xuriden will be commercially available in early 2016. The FDA granted Xuriden orphan drug designation because it treats a rare disease. Orphan drug designation provides financial incentives, such as clinical trial tax credits, user fee waivers, and eligibility for market exclusivity to promote rare disease drug development. Xuriden was also granted priority review. An FDA priority review provides for an expedited review of drugs for serious diseases or conditions that may offer major advances in treatment. The manufacturer of Xuriden was granted a rare pediatric disease priority review voucher, a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. In September 2014, Wellstat entered into an agreement with AstraZeneca under which the Pediatric Priority Review Voucher would be transferred to AstraZeneca upon approval. Financial terms of the agreement were disclosed.
Almac has been partnered with Wellstat for more than five years for the development of the active pharmaceutical ingredient and formulation of the drug product. Almac manufactured clinical, registration, and process validation batches, Almac will now produce the commercial product from its UK headquarter facilities, on behalf of Wellstat Therapeutics. Almac underwent a successful pre-approval inspection of its UK facilities in May of this year.