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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 has received FDA approval for the expanded use of TAKHZYRO (lanadelumab-flyo) as the first prophylaxis treatment for children aged 2 to <6 years with hereditary angioedema (HAE). This approval is based on efficacy data from the Phase 3 HELP and SPRING studies, showing a reduction in HAE attacks by 94.8% in pediatric patients. Previously, children 2 to <6 years lacked approved prophylactic options. TAKHZYRO is already available in over 60 countries and aims to address the needs of HAE patients through ongoing research and clinical programs.
Takeda (NYSE: TAK) reported strong Q3 2022 results with a 13.9% increase in revenue and 4.5% core revenue growth at constant exchange rates. Net profit rose 18.4%, and EPS rose 19.6%. The company approved the dengue vaccine QDENGA® in the EU and received priority review from the U.S. FDA. Takeda also announced an agreement to acquire a TYK2 inhibitor from Nimbus Therapeutics for USD 4 billion, enhancing its pipeline in autoimmune diseases. Despite revenue increases in most segments, oncology revenue fell 13% due to generic competition for VELCADE®.
Takeda Pharmaceutical has secured an exclusive licensing agreement with HUTCHMED for the development and commercialization of fruquintinib outside China, Hong Kong, and Macau. Fruquintinib, an inhibitor targeting VEGFR-1, 2, and 3, is aimed at treating refractory metastatic colorectal cancer (CRC). Takeda will pay HUTCHMED $400 million upfront, with potential additional payments of up to $730 million based on regulatory and sales milestones. The drug has shown promise in clinical trials and received Fast Track designation from the FDA. This partnership aims to enhance Takeda's oncology portfolio and expand treatment options for CRC patients.
Takeda announced the approval of EXKIVITY (mobocertinib) in China for treating adults with EGFR Exon20 insertion+ NSCLC who have progressed on platinum-based chemotherapy. This approval follows a Phase 1/2 clinical trial involving 114 patients, revealing a confirmed overall response rate (ORR) of 28% and a median duration of response (DoR) of 15.8 months. EXKIVITY is the first targeted therapy available for this patient group in China, addressing a significant unmet need as lung cancer is prevalent in the region.
Takeda (TSE:4502/NYSE:TAK) and Arrowhead Pharmaceuticals (NASDAQ:ARWR) announced positive results from the Phase 2 SEQUOIA study for fazirsiran in treating liver disease due to alpha-1 antitrypsin deficiency (AATD-LD). Notable findings include a 50% fibrosis regression in patients and a 94% median reduction in liver Z-AAT accumulation. Adverse events were balanced between treatment and placebo groups. A Phase 3 study is set to begin this month, aiming to confirm these promising Phase 2 results.
Takeda has announced encouraging interim results from its pivotal Phase 3 trial for TAK-755, a recombinant ADAMTS13 enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP), a rare blood disorder. The trial demonstrated a 60% reduction in thrombocytopenia events compared to standard care, with significantly fewer adverse events related to TAK-755 (8.9%) versus standard care (47.7%). Takeda plans to seek marketing authorization for TAK-755, aiming to provide a vital treatment option for patients with cTTP, who currently lack approved therapies.
Takeda's AURORA trial results indicate that maribavir achieved a 69.6% CMV clearance rate in hematopoietic stem cell transplant recipients, compared to 77.4% for valganciclovir, but did not meet non-inferiority criteria. However, at Week 16, maribavir showed a maintenance effect of 52.7% compared to 48.5% for valganciclovir. Maribavir demonstrated a favorable safety profile, with lower incidences of treatment-emergent neutropenia (21.2%) compared to valganciclovir (63.5%). Takeda continues to engage with regulatory authorities regarding these outcomes.
Takeda has announced its acquisition of NDI-034858 from Nimbus Therapeutics for $4B, aiming to enhance its late-stage pipeline in treating autoimmune diseases. NDI-034858, a selective TYK2 inhibitor, has shown promising Phase 2b results in psoriasis, with expected Phase 3 trials commencing in 2023. This strategic move aligns with Takeda's focus on immune-mediated diseases, potentially leading to significant portfolio expansion and improved patient outcomes. The deal includes milestone payments of $1B upon reaching specified sales targets. Takeda anticipates closing the transaction by FY2022.
Nimbus Therapeutics has entered into a definitive agreement for Takeda to acquire its subsidiary, Nimbus Lakshmi, Inc., along with the TYK2 inhibitor NDI-034858. The deal includes
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