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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 announced the U.S. FDA's acceptance of its Biologics License Application (BLA) resubmission for the investigational subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). This resubmission addresses FDA feedback from a 2019 Complete Response Letter (CRL). The resubmission includes additional data on the SC administration of Entyvio, which is currently available in intravenous form. Takeda expects a decision by the end of 2023. The pivotal VISIBLE 1 trial, assessing the SC formulation, involved 216 adult patients and demonstrated a primary endpoint of clinical remission at week 52. The SC formulation aims to offer patients an alternative to IV infusion, enhancing treatment options.
Takeda has received FDA approval for HYQVIA (Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase), enabling treatment of primary immunodeficiency (PI) in children aged 2 to 16. This supplement expands its market presence, as HYQVIA was initially authorized in 2014 for adults. The approval is based on a Phase 3 study demonstrating effective infection protection, showing a mean rate of acute serious bacterial infections (aSBIs) at 0.04 per year, significantly lower than the predefined target. The drug offers a less frequent treatment option (once a month) that can be administered at home after training. Takeda's commitment to plasma-derived therapies is reinforced through this expanded indication, catering to the specific needs of pediatric patients and their families.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced the dosing of the first patient in Takeda’s Phase 3 REDWOOD study for fazirsiran (TAK-999/ARO-AAT), targeting alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD). This event unlocks a $40 million milestone payment from Takeda to Arrowhead. Fazirsiran, an investigational RNA interference therapy, aims to reduce the production of the harmful Z-AAT protein. The study, involving 160 patients, evaluates the drug's efficacy and safety. Fazirsiran has previously received Breakthrough and Orphan Drug Designations from the FDA.
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