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Launch of ZEJULA® Tablets for the Treatment of Ovarian Cancer

Takeda Pharmaceutical Company today announced that it has launched ZEJULA® Tablets 100mg.

An application for manufacturing and marketing approval was submitted to the Ministry of Health, Labour and Welfare in November 2020, based on the results of the human bioequivalence study (Study 3000-01-004) and a dissolution study that confirmed the equivalence of ZEJULA Tablets and ZEJULA Capsules (niraparib tosylate hydrate, hereinafter "ZEJULA Capsules"). The application was approved on September 2, 2021. While ZEJULA capsules require refrigeration, one of the advantages of ZEJULA tablets is that they can be stored at room temperature.

Since the launch of ZEJULA capsules in Japan in 2020, Takeda have provided this treatment option to many patients with new-onset or recurrent ovarian cancer. It will keep working to make further contributions to ovarian cancer treatment.

In July 2017, Takeda entered into a licensing agreement for exclusive development and sales rights for ZEJULA in Japan with GSK (Head Office: UK; formerly TESARO, Inc.).

ZEJULA®

ZEJULA is the only once-daily oral PARP inhibitor for ovarian cancer. It received approval from the US Food and Drug Administration (FDA) in March 2017 as a maintenance therapy for adult patients with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Japan’s Ministry of Health, Labour and Welfare approved ZEJULA® 100mg capsules on September 25, 2020, as a maintenance treatment for patients with ovarian cancer who have undergone chemotherapy, as a maintenance treatment in platinum-sensitive recurrent ovarian cancer, and in homologous recombination deficient platinum-sensitive relapsed ovarian cancer. The product was then launched on November 20, 2020. In November 2020, Takeda filed an application with the MHLW for manufacturing and marketing approval of ZEJULA® 100 mg tablets, and this approval was granted on September 2, 2021.

Takeda Pharmaceutical

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. For more information, please visit https://www.takeda.com/jp/.

Disclaimer

The drug information contained herein is intended to disclose corporate information. Nothing contained in this document should be considered a solicitation, promotion, or indication for any prescription drug, including those currently under development.