Construction to Start on GCP2 Production Facility at Takeda Ireland Limited Site in Grange Castle

- Gives Takeda in-house production capacity to meet global demand for NINLARO^® (ixazomib)
- Puts Drug Substance, Drug Product, Packaging and Quality Control all under one roof
- Expected to become operational in the second half of FY2018

Zurich, Switzerland, May 31 and Osaka, Japan, June 1, 2017 — 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.

Fast Facts about Takeda’s New Production Facility

 

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information,visit https://www.takeda.com/newsroom.
Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website, www.takedaoncology.com.

About NINLARO^® (ixazomib) capsules

• NINLARO^® (ixazomib) is an oral proteasome inhibitor which is also being studied across the continuum of multiple myeloma treatment settings as well as systemic light-chain (AL) amyloidosis. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval. NINLARO^® was approved by the U.S. Food and Drug Administration (FDA) in November 2015 following a priority review.

• In November 2016, the European Commission granted conditional marketing authorization for NINLARO^®, indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy. With the European Commission’s decision, NINLARO^® was approved for use across the European Economic Area, which includes the European Union’s 28 member states as well as Norway, Liechtenstein and Iceland.

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.

Disclaimer
The drug information contained herein is intended to disclose Takeda's corporate information. Nothing contained herein should be considered a solicitation, promotion or indication for any prescription drug including the ones under development.

Media Contacts:
Media outside Japan
Victoria Hampson
Admin & Communications Executive
Takeda Ireland Limited (Bray)
[email protected]
+353 1 205 0603

Japanese media
Tsuyoshi Tada
[email protected]
+81-3-3278-2417

 <Artist's rendering of new production facility when completed>