Almac Group Clinical Supply and Commercial Solutions Support Agios’ Road to FDA Approval
March 22, 2022
Almac Group welcomes U.S. FDA Approval of First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase (PK) Deficiency
Almac Group, the global contract development and manufacturing organisation, is proud to confirm it has supported Agios Pharmaceuticals, Inc., a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, in the clinical trial and rapid commercial launch of PYRUKYND® (mitapivat).
The treatment is the first ever U.S. Food and Drug Administration (FDA) approved, disease-modifying therapy for adults with hemolytic anemia caused by PK (pyruvate kinase) deficiency, a rare, debilitating, and lifelong form of anemia.
Almac’s engagement with Agios began in 2014, while the treatment was under clinical study. During the pivotal Phase 3 study, Almac Clinical Services provided global clinical supply chain expertise to assist in bringing AG-348 / PYRUKYND® (mitapivat) to market. Almac Clinical Services provided a full suite of end-to-end clinical supply solutions including expert packaging, labelling, distribution and QP Services, all while working collaboratively with Almac Sciences and Almac Pharma Services to create a seamless bridge between Clinical and Commercial.
Most recently, Almac Pharma Services, which specialises in product development and commercial services, provided rapid launch commercial services in anticipation of FDA approval. This bespoke, proactive service leverages Almac’s highly experienced and tailored manufacturing and logistic expertise to anticipate and execute the bespoke printing, packaging, labelling, and shipment of a drug within hours of U.S. Food and Drug Administration Approval from the company’s Craigavon, Northern Ireland global headquarters.
Dr Robert Dunlop, Managing Director & President, Almac Clinical Services, states, “We send our congratulations to Agios on the FDA approval of PYRUKYND®, we hope this outstanding achievement will significantly improve the quality of life for patients who are living with this debilitating disease. We are proud to have supported this important clinical study and to work in partnership with Agios to deliver crucial supplies to trial patients. I would like to thank those within Almac Clinical Services who worked extremely efficiently to ensure timelines were met and product was delivered on time.”
Graeme McBurney, Managing Director & President, Almac Pharma Services, commented, “We are delighted to congratulate Agios on the FDA approval of PYRUKYND®, a remarkable step forward for patients who suffer from PK deficiency. As an organisation with a mission to advance human health, we have been honoured to support this work that addresses an unmet medical need and provides an unprecedented therapy for those patients who need it most. I would also like to thank our team at Almac Pharma Services, whose ongoing dedication has enabled the seamless, rapid launch of this product into the U.S. commercial space.”
“We are grateful to the team at Almac for their dedication to providing the highest quality service and care for people with PK deficiency in our clinical trials and those who are now getting access to the commercial product for the first time,” said Wendy Xia, Vice President Supply Chain, Agios. “Almac shares our deep commitment to supporting and partnering with the PK deficiency community, and with their collaboration, we have been able to expediently and seamlessly bring PYRUKYND® from the clinic to patients who previously had no approved treatment option.”