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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 approval from the Japan Ministry of Health for its recombinant protein-based COVID-19 vaccine, Nuvaxovid, for individuals aged 18 and older. The approval covers both primary and booster immunization, based on positive efficacy and safety data from clinical trials conducted in Japan and internationally. Takeda will manufacture the vaccine at its Hikari facility and begin distribution shortly. The financial impact of Nuvaxovid on Takeda's fiscal year ending March 31, 2023, will depend on distribution schedules, with forecasts to be revealed in May 2022.
Takeda has launched the TAKHZYRO® (lanadelumab-flyo) injection in a single-dose prefilled syringe format in the U.S. to prevent hereditary angioedema (HAE) attacks in patients aged 12 and older. Approved by the FDA in February 2022, this user-friendly option aims to enhance patient experience by simplifying the administration process. TAKHZYRO has been available since 2018 and shows proven efficacy in preventing HAE attacks, supported by one of the largest clinical studies in the field. Patients and specialty pharmacies will receive guidance for the transition to this new format.
Takeda Pharmaceutical Company Limited has completed its share buyback program as outlined in the Board of Directors’ resolution from
Takeda announced the completion of the SHP643-301 study, a Phase 3 trial evaluating TAKHZYRO (lanadelumab) for preventing acute attacks of hereditary angioedema (HAE) in pediatric patients aged 2 to <12 years. The study met its primary and secondary objectives, demonstrating a safety profile consistent with previous trials in older patients, with no serious adverse events reported. Takeda plans to initiate a global regulatory filing for this age group within the fiscal year.
Takeda proposes new candidates for independent external directors at its upcoming shareholders' meeting on June 29, 2022. The candidates, Kimberly A. Reed and John Maraganore, will replace retiring directors Toshiyuki Shiga and Shiro Kuniya. Additionally, Masami Iijima is nominated as the new chair of the Board Meetings, succeeding Masahiro Sakane. This move aims to enhance governance and diversity within the board. All current members will also be proposed for re-election.
Takeda has received approval from Japan's Ministry of Health, Labour and Welfare for TAKHZYRO (lanadelumab) subcutaneous injection in adults and pediatric patients aged 12 and older for preventing attacks of hereditary angioedema (HAE). This decision is primarily based on results from the global Phase 3 HELP Study and a Japan-specific Phase 3 trial, where 41.7% of patients did not experience attacks over 26 weeks. The drug is already approved in over 50 countries and aims to enhance treatment options for the HAE patient community.
Takeda presented interim real-world data from the Phase 4 EMPOWER study, showing significant improvements in Hereditary Angioedema (HAE) treatment outcomes with TAKHZYRO (lanadelumab). New users experienced an average 83% reduction in monthly attack rates, while established users reported enhanced treatment satisfaction. Key metrics included improvements in the Angioedema Quality of Life Questionnaire and a notable percentage of users extending treatment intervals from every 2 weeks to 4 weeks. Full data is expected in 2024.
Takeda has announced promising six-month interim results from the INSPIRE study, which evaluated the effectiveness of Alofisel (darvadstrocel) in patients with complex Crohn’s perianal fistulas. Clinical remission was observed in 65% of participants, with a clinical response rate of 73% for the All Treated group. The study has enrolled 230 patients as of September 2021. While adverse events were noted in 20% of participants, no serious incidents such as deaths or ectopic tissue formation were reported. These findings align with previous Phase 3 study results, supporting Alofisel's potential as a viable treatment option.
Takeda reported strong Q3 FY2021 results, achieving a +11% year-to-date revenue growth, amounting to
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