New €45 million facility will produce the cancer treatment NINLARO (ixazomib) for the global market.
Japanese drug maker Takeda Pharmaceutical Company Limited broke ground on a new production facility at its existing Grange Castle Business Park site in Dublin, Ireland. Initially announced in December 2016 by Ireland’s Minister for Jobs, Enterprise and Innovation, the investment involves construction of a separate plant, with a provisional name of GCP2 Ninlaro® Facility, for the manufacture of the cancer treatment NINLARO® (ixazomib). It will be a high-containment facility and enable production of sufficient quantities of the drug to meet global demand.
Construction of the plant is being managed by Project Management Group, which also designed the facility. Takeda expects the plant to be completed in the second quarter of 2018 and fully operational with shipment of final product in the second half of 2018. Unlike most pharmaceutical production facilities, the new Takeda plant will include capabilities for drug substance and drug product manufacturing, primary and secondary packaging and QC support in one location.
“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®.”
NINLARO® has been approved by the by the U.S. Food and Drug Administration (FDA), the Japanese Ministry of Health, Labor and Welfare and the European Medicines Agency. Takeda has also submitted applications for the approval of NINLARO® to many other regulatory authorities around the world.
The drug is the first oral proteasome inhibitor approved in Japan and is indicated in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. It is also the first and only once-weekly oral proteasome inhibitor approved in the U.S. (following priority review) for the treatment of patients with multiple myeloma who have received at least one prior therapy, according to Takeda. The new drug makes possible an all-oral proteasome inhibitor-based triplet treatment regimen for the first time. In Europe, Takeda received conditional marketing authorization for NINLARO® in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy.
“NINLARO® was created with patients in mind and aspires to overcome the challenges of today’s treatments to enable patients to stay on proteasome inhibition therapy for the optimal duration in the real world setting,” stated the company. Offered as capsules for oral administration, NINLARO® is also being studied across the continuum of multiple myeloma treatment settings as well as systemic light-chain (AL) amyloidosis.