Takeda Pharmaceutical Company Limited has held a groundbreaking ceremony for its new production facility at the Grange Castle site in Ireland. The facility will be dedicated to manufacturing Takeda's oncology product, NINLARO, for global markets. The construction of the plant will be managed by Project Management Group with an investment of over €40m ($45m). The facility is expected to be completed in Q2 FY2018 and will create approximately 40 new jobs over the next two years. NINLARO is the first and only once-weekly oral proteasome inhibitor launched in the US for the treatment of multiple myeloma.
Construction to Start on GCP2 Production Facility at Takeda Ireland Limited Site in Grange Castle
Zurich, Switzerland, May 31 and Osaka, Japan — Takeda Pharmaceutical Company Limited (“Takeda”, TSE: 4502) announced today that a groundbreaking ceremony had been held for its new production facility at the existing Grange Castle site in Ireland.
The investment was announced last December by Ireland’s Minister for Jobs, Enterprise and Innovation Mary Mitchell O’Connor TD. Takeda’s existing footprint at the Grange Castle site will be expanded with the construction of a new standalone, high-containment production facility dedicated to manufacturing its oncology product NINLARO® for global markets. The investment will create approximately 40 new jobs over the next two years.
“Our new plant in Grange Castle, Ireland is a strategic investment for Takeda,” said Thomas Wozniewski, Global Manufacturing & Supply Officer of Takeda. “It will give us the crucial in-house manufacturing capacity to meet the increasing demand for our innovative product NINLARO®.”
The construction of the plant, which begins in June 2017, will be managed by Project Management Group with over 40 million euros investment in total. The plant is scheduled to be completed in Q2 FY2018 and become operational to commence shipment of secondary packaged product in the second half of FY2018.
The new production facility will be unique in that it will house the Drug Substance, Drug Product, Primary and Secondary Packaging and QC processes all under one roof.
NINLARO® was approved in November 2015 by the U.S. Food and Drug Administration (FDA). It is the first and only once-weekly oral proteasome inhibitor launched in the U.S. for the treatment of patients with multiple myeloma who have received at least one prior therapy, enabling an all-oral proteasome inhibitor-based triplet treatment regimen for the first time. Additionally, NINLARO® was approved by the Japanese Ministry of Health, Labour and Welfare in March 2017 and launched in May as the first oral proteasome inhibitor in Japan, indicated in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma.
NINLARO® has also been approved by the European Commission. Takeda has submitted applications for approval of NINLARO® to multiple other regulatory authorities around the world.