Almac Group Clinical Supply And Commercial Solutions Support Agios' Road To FDA Approval

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 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.”

About Almac Clinical Services
The most comprehensive Global Clinical Supply Chain Solution in the marketplace

Almac Clinical Services has over 30 years’ experience deploying clinical supply chain expertise and a full suite of end-to-end clinical solutions to over 600 Pharmaceutical and Biotech companies worldwide.

Guided by extensive clinical supply experience and expertise, Almac Clinical Services are recognised as one of the leading, multi-faceted, global solution providers within the niche and complex market of clinical trial supply.

About Almac Pharma Services
Tailormade pharmaceutical development and commercial solutions

With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.

With facilities located in Europe and the US, we provide tailored, quality-led and timely solutions from early and late phase pharmaceutical development, commercial drug product manufacture, commercial packaging through to global storage & distribution.

About Almac Group
A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 6,000 highly skilled personnel across 18 facilities including Europe, the US and Asia.