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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 (TSE:4502/NYSE:TAK) announced plans to propose Miki Tsusaka as a new independent external director at the 147th Ordinary Meeting of Shareholders on June 28, 2023. This follows the retirement announcement of Masato Iwasaki, who has served for nearly 40 years, significantly contributing to Takeda's transformation as a global biopharmaceutical leader. Tsusaka brings strong expertise from her role as President of Microsoft Japan and her previous experience at Boston Consulting Group. Takeda emphasizes its commitment to board diversity, aiming to strengthen governance and pursue its vision as a leading digital biopharmaceutical company.
BioLife Plasma Services, part of Takeda, has opened its 200th plasma donation center in the U.S. with new locations in West Springfield, Massachusetts and Pearland, Texas. This expansion is crucial for addressing the increasing demand for life-saving plasma therapies for rare conditions. Each new center generates an estimated $4-5 million in local community contributions and creates around 70 jobs. BioLife emphasizes inclusivity in the donation process and operates over 50 bilingual centers across the U.S., enhancing accessibility for diverse communities.
Takeda's TAK-279, an allosteric TYK2 inhibitor, showed promising results in a Phase 2b clinical trial for moderate-to-severe plaque psoriasis, presented on March 18, 2023, at the AAD Annual Meeting. Involving 259 patients, the trial demonstrated significant efficacy with patients on TAK-279 achieving PASI 75 (44%-67%), PASI 90 (21%-46%), and PASI 100 (10%-33%) compared to placebo (6%, 0%, 0%, respectively; p<0.001). Notably, the 2mg dose did not show significant benefits. Nimbus Therapeutics highlighted the unmet need addressed by TAK-279, steering towards further development in immune-mediated diseases.
Takeda has announced promising results from its Phase 2b trial for TAK-279, a selective oral TYK2 inhibitor, showing significant effectiveness in treating moderate-to-severe plaque psoriasis. Patients receiving dosages of 5mg, 15mg, and 30mg achieved Psoriasis Area and Severity Index (PASI) scores of 75, 90, and 100, substantially higher than the placebo. A Phase 3 study is set to commence in FY2023, along with further evaluations in other immune-mediated diseases such as systemic lupus erythematosus and inflammatory bowel disease. The trial involved 259 patients, with mild to moderate adverse events noted.
Hannon Armstrong Sustainable Infrastructure Capital, Inc. (NYSE: HASI) announced the appointment of Kimberly A. Reed and Jeffrey A. Lipson to its Board of Directors effective March 1, 2023. With this change, the Board now comprises 11 members, 9 being independent. Reed, a former chairman and CEO of the U.S. Export-Import Bank, will add valuable regulatory insight and financial expertise. Lipson, who previously served as COO and CFO, assumes the CEO role, marking a leadership transition for HASI, which manages over $9 billion in assets focused on climate solutions.
Takeda announced significant results from the Phase 3 GRAPHITE study, demonstrating that vedolizumab significantly improved intestinal aGvHD-free survival at Day 180 after allo-HSCT, achieving a response rate of 85.5% compared to 70.9% for placebo (p<0.001). The study, presented at the 2023 Tandem Meetings, also showed no new safety signals with vedolizumab. This treatment addresses a critical unmet need in managing lower gastrointestinal aGvHD, a serious complication after stem cell transplantation. The study included 333 patients and marks an advancement in understanding vedolizumab's role in gastrointestinal inflammatory conditions.
Nimbus Therapeutics has completed the acquisition of its subsidiary Nimbus Lakshmi, Inc. by Takeda, with an upfront payment of $4 billion. This acquisition includes Nimbus's TYK2 inhibitor program, featuring the oral drug TAK-279. Nimbus anticipates receiving up to an additional $2 billion in sales-based milestone payments. The drug, designed to treat immune-mediated diseases, has shown promising results in a Phase 2b trial for moderate-to-severe plaque psoriasis, meeting its primary efficacy endpoint. Nimbus retains its pipeline for other therapies targeting cancer and autoimmune diseases.
Takeda has completed the acquisition of Nimbus Lakshmi, Inc., acquiring full shares from Nimbus Therapeutics for about 4 billion USD. This significant transaction, announced on December 13, 2022, and finalized on February 8, 2023, includes acquiring the promising asset TAK-279, a selective oral TYK2 inhibitor. Phase 2b data is scheduled for release in Q4 FY2022, with a Phase 3 study aimed at psoriasis expected to commence in 2023. The acquisition enhances Takeda's late-stage pipeline, with potential applications across various immune-mediated diseases, supporting long-term growth.
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®.
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