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Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese multinational corporation, stands as Asia's largest and one of the globe's top 20 pharmaceutical giants by revenue. Headquartered in Tokyo, Takeda operates across approximately 80 countries, merging American and British roots into its vast global presence.
With a revenue of JPY 4.3 trillion in fiscal 2023, Takeda dedicates its efforts predominantly to five therapeutic areas: oncology, gastroenterology, neuroscience, rare diseases, and plasma-derived therapies, which collectively generate more than 80% of its revenue. Takeda’s global footprint is diversified, with 50% of its revenue originating from the US, 20% from Japan, and another 20% from Europe and Canada.
Noteworthy for its robust pipeline and commitment to innovation, Takeda partners with various organizations to push the boundaries of medical research. A recent highlight includes a joint venture with Astellas Pharma Inc. and Sumitomo Mitsui Banking Corporation. This collaboration aims to incubate early drug discovery programs, striving to transition academic breakthroughs into practical medical treatments.
Moreover, Takeda's strategic partnership with Neurocrine Biosciences to develop NBI-1065845, an investigational treatment for major depressive disorder, showcases its dedication to addressing unmet medical needs. The positive Phase 2 results of the SAVITRI™ study underline the potential of NBI-1065845 to provide hope for patients with inadequate responses to existing treatments.
Takeda's philosophy focuses on creating a healthier world through life-transforming treatments in its core areas. Their values-based, R&D-driven approach has sustained their leadership in the pharmaceutical sector for over two centuries.
Takeda presented positive Phase 2b trial results for TAK-861, an oral orexin receptor 2 agonist, in treating narcolepsy type 1 (NT1) at SLEEP 2024. The trial showed statistically significant and clinically meaningful improvements across primary and secondary endpoints over 8 weeks, including increased sleep latency and reduced cataplexy. TAK-861 was generally safe and well tolerated, with no serious adverse events. The Phase 3 trials are set to commence in the first half of FY 2024. The FDA has granted Breakthrough Therapy designation to TAK-861 for excessive daytime sleepiness in NT1.
Takeda and Pfizer announced positive four-year results from the Phase 3 HD21 trial. The trial evaluated ADCETRIS® (brentuximab vedotin) in combination with chemotherapy for treating newly diagnosed Stage IIb/III/IV classical Hodgkin lymphoma. Conducted by the German Hodgkin Study Group (GHSG), the study showed that the ADCETRIS combination significantly improved progression-free survival (PFS) and had a better safety profile compared to the standard eBEACOPP regimen. The results will be presented at the ASCO and EHA 2024 meetings. After 48 months, the ADCETRIS combination showed a 94.3% PFS rate versus 90.9% for eBEACOPP. Additionally, the ADCETRIS regimen was associated with fewer acute and long-lasting toxicities. Takeda and Pfizer are responsible for regulatory filings and commercialization in different regions.
Takeda has received a positive opinion from the EMA's CHMP for recombinant ADAMTS13 (rADAMTS13) for treating congenital thrombotic thrombocytopenic purpura (cTTP).
If approved, rADAMTS13 will be the first enzyme replacement therapy for cTTP in the EU. cTTP is an ultra-rare blood clotting disorder with a high mortality rate if untreated.
This recommendation is based on comprehensive evidence, including results from a Phase 3 trial, published in May 2024. The European Commission will now consider this opinion for potential marketing authorization in the EU.
Takeda (TSE: 4502/NYSE:TAK) announced its participation in the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO) from May 31-June 4, 2024, in Chicago. The company will present data on its oncology pipeline and product portfolio, covering various cancers such as colorectal, lung, lymphoma, multiple myeloma, and leukemia. Presentations will include both clinical and real-world data aimed at enhancing treatment approaches. Key highlights will feature data on Hodgkin lymphoma and colorectal cancer, emphasizing Takeda’s commitment to combining internal innovations with external partnerships. Takeda continues its mission to provide transformative medicines and improve patient care.
Takeda announced its FY2023 full year results, showing +5.9% revenue growth at AER and +1.5% at CER, with a -13.3% core operating profit change at CER due to generic impact and R&D investment. The company aims for a 100-250 basis points core operating profit margin improvement each year from FY2025. Takeda's financial performance exceeded expectations, with three new therapy approvals from the U.S. FDA in FY2023 and up to six NMEs in phase 3 development in FY2024. The company plans to implement an efficiency program in FY2024 to drive organizational agility, procurement savings, and leverage data, digital, and technology capabilities.
Takeda (NYSE:TAK) has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the approval of fruquintinib, a targeted therapy for previously treated metastatic colorectal cancer (mCRC). If approved by the European Commission, fruquintinib will be a novel treatment in the EU, highlighting its status as the first therapy to inhibit all three vascular endothelial growth factor receptors (VEGFR-1, -2, -3) for mCRC in over a decade. The therapy showed significant improvements in overall survival and progression-free survival in Phase 3 FRESCO-2 trials compared to the current standard care.
Fruquintinib's potential impacts are substantial, offering a new chemotherapy-free option that improves patient outcomes. It has already been approved in the U.S. under the brand name FRUZAQLA® as of November 2023, and launched in China in 2018 as ELUNATE®. Key safety information includes risks such as hypertension, hemorrhagic events, infections, and hepatotoxicity among others.
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