Agios Pharmaceuticals Celebrates PYRUKYND® Launch Success with Almac Group
November 22, 2022
First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase (PK) Deficiency
Craigavon, Northern Ireland – 22 November 2022 – Almac Group, the global contract development and manufacturing organization, hosted a visit from strategic partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, to jointly celebrate the launch of its product PYRUKYND® (mitapivat) in the United States.
PYRUKYND is the first disease-modifying therapy for Hemolytic Anemia in adults with Pyruvate Kinase (PK) Deficiency – a rare, debilitating blood disorder which causes red blood cells to be broken down prematurely. The treatment was approved by the U.S. Food and Drug Administration (FDA) in February this year.
A team from Agios visited Almac Group’s headquarter facility in Craigavon, Northern Ireland, to meet the Almac team responsible for managing the successful clinical trial distribution and rapid multi-SKU launch of PYRUKYND earlier this year.
During its pivotal Phase 3 study, Almac Clinical Services provided global clinical supply chain expertise to assist in bringing PYRUKYND (mitapivat) to market. A full suite of end-to-end clinical supply solutions including clinical packaging, labeling, distribution and QP Services was provided, all while working collaboratively with Almac Sciences and Almac Pharma Services to create a seamless bridge between clinical and commercial development.
Agios then leveraged Almac Pharma Services’ highly experienced and tailored manufacturing and logistics expertise to anticipate and execute the bespoke printing, packaging, labeling, and shipment of multiple batches across the US within hours of FDA approval.
During the visit, Agios presented Almac with the ‘Agios Arete Award’ for ‘thriving to do the absolute best, both in Almac Pharma Services and Almac Clinical Services, one patient at a time’. The term ‘Arete’ is taken from the Greek word meaning ‘living up to one’s full potential and executing with excellence’. The award was created exclusively for Almac by an artist in Massachusetts.
“We were pleased to celebrate the successful launch of PYRUKYND with the team at Almac, and we are so appreciative of their partnership as we worked together to efficiently to bring this new medicine to patients who previously had no options,” said Wendy Xia, Vice President and Head of Supply Chain, Agios. “At Agios, we are fuelled by connections, and Almac’s expertise, collaboration, and unflagging dedication to patients were critical to the seamless launch of this first-in-class medicine for people with PK deficiency.”
The visit marked a key point in Almac Pharma Services’ relationship with Agios, providing the team with the first opportunity to see their product on site before being packed and prepared for shipment.
“We were thrilled to host this visit by Agios which was long awaited due to restrictions imposed throughout the pandemic. To receive recognition in the form of the ‘Agios Arete Award’ for our services is an absolute honor and we are delighted to share in Agios’ success. All credit goes to the multi-disciplinary teams who worked diligently to successfully deliver the timely rapid launch of PYRUKYND to patients in need and support Agios in their commitment to make a difference for people with PK deficiency.” commented Grainne Hughes, VP Business Support Operations, Almac Pharma Services.
Richard Segiel, VP Business Development North America, Almac Clinical Services, said: “We have a strong and developing relationship with Agios and are delighted with this award. Ultimately, we all strive to deliver as best we can to the benefit of every patient on every trial. Successful collaboration across the different teams and functions for both Almac and Agios has resulted in this success. We are so very proud of playing a part in helping treat patients with PK deficiency and look forward to collaborating more in the future.”
About Agios Pharmaceuticals, Inc.
Agios is a biopharmaceutical company that is fueled by connections. The Agios team cultivates strong bonds with patient communities, healthcare professionals, partners and colleagues to discover, develop and deliver therapies for genetically defined diseases. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for adults with PK deficiency, the first disease-modifying therapy for this rare, lifelong, debilitating hemolytic anemia. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. In addition to its clinical pipeline, Agios has multiple investigational therapies in preclinical development and an industry-leading research team with unmatched expertise in cellular metabolism and genetics. For more information, please visit the company’s website at www.agios.com.
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, clinical and commercial drug product manufacture, product launch through to commercial packaging and global distribution.
About Almac Group
A unique culture delivering exceptional solutions
The Almac Group is an established contract development and manufacturing organization 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 commercialization, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization which has grown organically over the past five decades now employing over 6,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.