Takeda Pharm - TAK STOCK NEWS

Takeda (TSE:4502/NYSE:TAK) will present additional data from Phase 2b trials and long-term extension study of TAK-861, an investigational oral orexin receptor 2 selective-agonist, for narcolepsy at Sleep Europe 2024. The presentations will highlight TAK-861's impact on daily functioning, cognition, and sleep quality in narcolepsy type 1 (NT1) and type 2 (NT2) patients. Based on positive Phase 2b results, Takeda has initiated the FirstLight Study, a global Phase 3 trial evaluating TAK-861 in adults with NT1. The drug aims to address the underlying pathophysiology of NT1 and could potentially become the first treatment to do so. Takeda is also developing assets for narcolepsy type 2 and idiopathic hypersomnia.

Takeda has committed JPY4.6 billion (approx. USD 32 million) to five new Global Corporate Social Responsibility (CSR) partners, aiming to improve health systems in low and middle-income countries. This initiative is expected to impact 27 million people across 93 countries by 2030. The new partnerships will focus on:

1. Expanding vaccine access through pharmacy-based immunization in Africa
2. Integrating community-driven healthcare in rural South Africa
3. Increasing care access for women and girls in conflict-affected areas
4. Building skilled health workforces in African countries
5. Strengthening national health systems for disease outbreak response

These partnerships were selected by over 22,000 Takeda employees worldwide, demonstrating the company's commitment to collaborative global corporate giving. Since 2016, Takeda's Global CSR Program has reached 17.8 million direct beneficiaries in 93 countries, contributing to various aspects of health system strengthening.

Takeda has received European Commission approval for ADZYNMA, the first and only recombinant ADAMTS13 replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare, potentially fatal blood-clotting disorder with treatment options. The approval is based on the totality of evidence, including results from the first randomized, controlled, open-label, crossover Phase 3 cTTP trial.

Key points:

• ADZYNMA is now approved for treating ADAMTS13 deficiency in children and adult patients with cTTP in the EU
• The Phase 3 trial showed no acute TTP events in patients receiving ADZYNMA prophylactic treatment
• ADZYNMA demonstrated a favorable safety profile compared to plasma-based therapies
• Takeda is also investigating recombinant ADAMTS13 for immune-mediated TTP in an ongoing Phase 2b trial

Takeda reported strong Q1 FY2024 results, with revenue growth of 14.1% at AER and 2.1% at CER. Growth & Launch Products drove performance, increasing 17.8% at CER and representing 46% of total revenue. Core Operating Profit rose 4.5% at CER, with a margin of 31.6%. The company maintained its full-year forecast and management guidance.

Key highlights include:

• Geographic expansion with approvals of LIVTENCITY in Japan and FRUZAQLA in EU
• Positive Phase 2b data for TAK-861 in narcolepsy type 1 and mezagitamab for ITP
• Q1 revenue of 1,208.0 billion yen and Core Operating Profit of 382.3 billion yen
• Core EPS of 176 yen, up 17.5% year-over-year

Takeda has announced new director assignments, decided at the Board of Directors and Audit and Supervisory Committee meetings following the 148th Ordinary Meeting of Shareholders. The Board is composed of 11 external directors out of 14 total members, ensuring transparency and objectivity.

An external director will continue to chair the Board. The Audit and Supervisory Committee, Nomination Committee, and Compensation Committee will be composed solely of external directors.

The new assignments include Christophe Weber as Representative Director and CEO, Milano Furuta as Director and CFO, and Andrew Plump as Director of R&D. External directors such as Masami Iijima, Ian Clark, and Steven Gillis hold various roles, ensuring robust governance.

These changes are effective from June 26, 2024, and emphasize Takeda's commitment to strong, independent governance.

Takeda announced the Japanese Ministry of Health, Labour and Welfare's approval of LIVTENCITY® (maribavir) for post-transplant cytomegalovirus (CMV) infection/disease resistant to existing anti-CMV therapies. LIVTENCITY is the first and only post-transplant treatment in Japan that targets pUL97 kinase. The approval is based on Phase 3 SOLSTICE trial results, which demonstrated significant improvement with maribavir over alternative treatments in clearing CMV viremia by Week 8. The trial included 235 maribavir patients and 117 on alternative treatments, with adverse reactions in 60.3% of maribavir patients. An additional Japanese Phase 3 study showed 33.3% efficacy at clearing CMV viremia by Week 8, with adverse reactions in 36.6% of patients.

Takeda unveiled positive results from its Phase 2b study of mezagitamab (TAK-079) in treating persistent or chronic primary immune thrombocytopenia (ITP). The study showed rapid and sustained platelet increases among patients receiving mezagitamab, with effects persisting for eight weeks post-treatment.

Among patients treated with the 600mg dose, 81.8% achieved complete platelet response, 90.9% achieved clinically meaningful platelet response, and 100% achieved hemostatic platelet response. Adverse events (AEs) were lower in the mezagitamab group compared to placebo. Takeda plans to initiate a Phase 3 trial in the second half of FY2024.

Takeda has received European Commission (EC) approval for FRUZAQLA (fruquintinib) as a treatment for adult patients with metastatic colorectal cancer (mCRC) who have exhausted other standard therapies. This approval follows the Phase 3 FRESCO-2 trial, which demonstrated significant efficacy and a manageable safety profile for FRUZAQLA. The EC decision was preceded by a positive opinion from the CHMP on April 25, 2024, and an FDA approval on November 8, 2023. FRUZAQLA is now the first new targeted therapy for mCRC in the EU in over a decade, providing a new option for patients regardless of their biomarker status.

Takeda has shared long-term data from the Phase 3 ADVANCE-CIDP 3 clinical trial, evaluating HYQVIA for treating chronic inflammatory demyelinating polyneuropathy (CIDP). The study, the longest of its kind, demonstrated HYQVIA's safety, tolerability, and low relapse rate, supporting its use as maintenance therapy. Presented at the PNS Annual Meeting, HYQVIA is the first facilitated subcutaneous immunoglobulin for CIDP, approved by the FDA and European Commission. The trial involved 85 patients over 33 months, reporting consistent safety profiles with no new concerns. Adverse events were mostly mild or moderate, with serious events in three patients. Results indicated stable disease maintenance with a low annualized relapse rate of 4.5%.