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Yahoo
a day ago
- Business
- Yahoo
Takeda's oral narcolepsy drug shines in two Phase III trials
Takeda's oral narcolepsy drug, oveporexton, has met the primary and secondary endpoints in two Phase III trials. The FirstLight (NCT06470828) and RadiantLight (NCT06505031) trials both met all their endpoints in patients with narcolepsy type 1 (NT1) after 12 weeks of treatment. The primary and secondary endpoints measured changes in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions. These were all statistically significant and clinically meaningful improvements, achieving near normal ranges across the broad range of symptoms investigated. The drug also remained generally well-tolerated with a safety profile consistent with other oveporexton studies, with the most common adverse events (AEs) being insomnia, urinary urgency and frequency. No serious treatment-related adverse events were reported. Based on the study results, Takeda plans to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) and other global regulators during the 2025 fiscal year. Oveporexton (TAK-861) is an investigational oral orexin receptor 2 (OX2R)-selective agonist. It is designed to address the core cause of NT1 by compensating for orexin deficiency, aiming to improve wakefulness and restore normal sleep-wake patterns. Orexin is a natural brain chemical that plays a crucial role in maintaining wakefulness and regulating the sleep-wake cycle. Takeda president Christophe Weber said: 'We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda's strength in discovering and developing a potential new class of medicines for difficult-to-treat diseases such as narcolepsy type 1.' Of the patients across the two Phase III studies, more than 95% enrolled in the ongoing long-term extension (LTE) study. In 2020, Jazz Pharmaceuticals' Xywav (calcium, magnesium, potassium, and sodium oxybates) was approved by the FDA and was the first approved new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years. Other treatment options for NT1 include trying to manage a regular sleeping pattern, as well as therapies, including stimulants such as Provigil (modafinil), Nuvigil (armodafinil), and Ritalin (methylphenidate) to promote wakefulness. Patients may also receive solriamfetol or pitolisant. To help with cataplexy attacks, either sodium oxybate or some antidepressants such as SSRIs [selective serotonin reuptake inhibitors] and SNRIs [serotonin-norepinephrine reuptake inhibitors] can be used to manage symptoms. If approved, GlobalData predicts sales of oveporexton will reach $1bn in 2030. GlobalData is the parent company of Clinical Trials Arena. "Takeda's oral narcolepsy drug shines in two Phase III trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
a day ago
- Business
- Yahoo
Takeda's oral narcolepsy drug shines in two Phase III trials
Takeda's oral narcolepsy drug, oveporexton, has met the primary and secondary endpoints in two Phase III trials. The FirstLight (NCT06470828) and RadiantLight (NCT06505031) trials both met all their endpoints in patients with narcolepsy type 1 (NT1) after 12 weeks of treatment. The primary and secondary endpoints measured changes in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions. These were all statistically significant and clinically meaningful improvements, achieving near normal ranges across the broad range of symptoms investigated. The drug also remained generally well-tolerated with a safety profile consistent with other oveporexton studies, with the most common adverse events (AEs) being insomnia, urinary urgency and frequency. No serious treatment-related adverse events were reported. Based on the study results, Takeda plans to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) and other global regulators during the 2025 fiscal year. Oveporexton (TAK-861) is an investigational oral orexin receptor 2 (OX2R)-selective agonist. It is designed to address the core cause of NT1 by compensating for orexin deficiency, aiming to improve wakefulness and restore normal sleep-wake patterns. Orexin is a natural brain chemical that plays a crucial role in maintaining wakefulness and regulating the sleep-wake cycle. Takeda president Christophe Weber said: 'We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda's strength in discovering and developing a potential new class of medicines for difficult-to-treat diseases such as narcolepsy type 1.' Of the patients across the two Phase III studies, more than 95% enrolled in the ongoing long-term extension (LTE) study. In 2020, Jazz Pharmaceuticals' Xywav (calcium, magnesium, potassium, and sodium oxybates) was approved by the FDA and was the first approved new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years. Other treatment options for NT1 include trying to manage a regular sleeping pattern, as well as therapies, including stimulants such as Provigil (modafinil), Nuvigil (armodafinil), and Ritalin (methylphenidate) to promote wakefulness. Patients may also receive solriamfetol or pitolisant. To help with cataplexy attacks, either sodium oxybate or some antidepressants such as SSRIs [selective serotonin reuptake inhibitors] and SNRIs [serotonin-norepinephrine reuptake inhibitors] can be used to manage symptoms. If approved, GlobalData predicts sales of oveporexton will reach $1bn in 2030. GlobalData is the parent company of Clinical Trials Arena. "Takeda's oral narcolepsy drug shines in two Phase III trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
a day ago
- Business
- Business Upturn
Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1
Business Wire India – Both Phase 3 Studies Met all Primary and Secondary Endpoints Demonstrating Statistically Significant Improvements Across Symptoms at All Doses, Building Upon Phase 2b Results – Oveporexton was Generally Well-Tolerated in Phase 3 Safety Profile – Takeda is Rapidly Advancing Regulatory Submissions and Launch Preparedness with the Aim to Bring Oveporexton to People Living with Narcolepsy Type 1 as Quickly as Possible – These Results Mark a Major Advancement Toward Transforming the Standard of Care by Addressing the Underlying Cause of Narcolepsy Type 1 Takeda (TSE:4502/NYSE:TAK) today announced that all primary and secondary endpoints were met in two Phase 3 randomized, double-blind, placebo-controlled studies of oveporexton (TAK-861), a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist, in narcolepsy type 1 (NT1). NT1 is caused by the loss of orexin-producing neurons in the brain. Orexin agonists are designed to address this underlying orexin deficiency. For the first time, this mechanism of action has been validated in Phase 3 studies demonstrating significant improvement across a broad range of symptoms. These results reinforce the potential of oveporexton to transform the standard of care. 'We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda's strength in discovering and developing a potential new class of medicines for difficult to treat diseases such as narcolepsy type 1,' said Christophe Weber, president and chief executive officer at Takeda. "Our leadership in orexin biology and building a multi-asset orexin franchise with transformative potential will position Takeda for long-term future growth.' The FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies were two large, global Phase 3 studies conducted in 19 countries. Both studies achieved statistically significant improvement compared to placebo with p-values of <0.001 for all primary and secondary endpoints across all doses at week 12. The primary and secondary endpoints measuring objective and patient reported improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions demonstrate statistically significant and clinically meaningful improvements achieving near normal ranges across the broad range of symptoms investigated. Oveporexton was generally well-tolerated with a safety profile from the Phase 3 studies overall consistent with oveporexton studies to date including the Phase 2b study. No serious treatment-related adverse events were reported. The most common adverse events were insomnia, urinary urgency and frequency. More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension (LTE) study. 'We are grateful to the patients who took part in these clinical studies and to their families, the investigators and clinical staff. The studies were accelerated at an unprecedented pace with the aim to bring this potential treatment to people living with narcolepsy type 1 as quickly as possible,' said Andy Plump, M.D., Ph.D., president of R&D at Takeda. 'The comprehensive assessments from our Phase 3 studies build on the transformative results we saw with our Phase 2b study with most participants reaching normative ranges and reporting clinically meaningful improvement across a broad range of symptoms at the end of the 12-week treatment period. The positive results also reinforce the continued momentum for our late-stage pipeline, which we believe will deliver value to the patients we serve around the world.' Takeda intends to present the results at upcoming medical congresses and plans to submit a New Drug Application with the United States Food and Drug Administration and additional global regulatory authorities in fiscal year 2025. Results from the Phase 3 studies have no significant impact on the full year consolidated forecast for the fiscal year ending March 31, 2026. About Narcolepsy Type 1 (NT1) and Orexin Science NT1 is a chronic, rare neurological disease that results in a range of debilitating symptoms including excessive daytime sleepiness (EDS), cataplexy, disrupted nighttime sleep, sleep paralysis and hallucinations upon falling asleep or waking. Additionally, individuals living with NT1 often report cognitive symptoms, including difficulty thinking clearly, remembering, concentrating and paying attention. NT1 is caused by loss of the orexin-producing neurons in the brain, which regulate wakefulness and sleep, and is also believed to be essential to other functions such as attention through activation of orexin receptors. Currently, the standard of care is limited to symptomatic therapies that may only partially address some of the symptoms people face. About Oveporexton (TAK-861) Oveporexton (TAK-861) is an investigational orexin receptor 2 (OX2R)-selective agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency that causes narcolepsy type 1 (NT1). By activating OX2Rs, oveporexton is designed to promote wakefulness and reduce abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy, to address the broad spectrum of daytime and nighttime symptoms. About the FirstLight and RadiantLight Phase 3 Studies FirstLight (TAK-861-3001; NCT06470828) and RadiantLight (TAK-861-3002; NCT06505031) are global, multicenter, placebo-controlled studies to evaluate the efficacy, safety and tolerability of oveporexton compared to placebo in patients with narcolepsy type 1 (NT1) over 12 weeks. The studies were conducted in 19 countries with enrollment completed within six months. The FirstLight study enrolled 168 participants randomized to one of three dosing arms (high dose, low dose and placebo). The RadiantLight study enrolled 105 participants randomized to two dosing arms (high dose and placebo). The primary endpoint in both studies was improvement in excessive daytime sleepiness (EDS) as measured by the Maintenance of Wakefulness Test (MWT), a standard measure of wakefulness. Key secondary endpoints included improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) and in the Weekly Cataplexy Rate (WCR), a measure evaluating cataplexy. The studies also evaluated the effect of oveporexton on participants' ability to maintain attention, participants' overall quality of life, the spectrum of narcolepsy symptoms and daily life functions, as well as the safety and tolerability of oveporexton. About Takeda's Orexin Agonists for Sleep-Wake Disorders Takeda is leading the field of orexin science with a multi-asset franchise. Orexin is a key regulator of sleep and wake patterns and contributes to other essential functions including attention, mood, metabolism and respiration. Oveporexton (TAK-861) is the lead investigational orexin receptor 2 (OX2R) agonist asset in Takeda's orexin franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 (NT1) from the U.S. Food and Drug Administration and the Center for Drug Evaluation of China's National Medical Products Administration. The company is also investigating other orexin agonists in populations with orexin levels in the normal range, including TAK-360, an oral OX2R agonist initially being investigated for the treatment of narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other potential indications where orexin signaling is implicated. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Important Notice For the purposes of this notice, 'press release' means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ('Takeda') regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as 'targets', 'plans', 'believes', 'hopes', 'continues', 'expects', 'aims', 'intends', 'ensures', 'will', 'may', 'should', 'would', 'could', 'anticipates', 'estimates', 'projects', 'forecasts', 'outlook' or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire India. Business Upturn take no editorial responsibility for the same. Ahmedabad Plane Crash
Business Wire
2 days ago
- Business
- Business Wire
Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that all primary and secondary endpoints were met in two Phase 3 randomized, double-blind, placebo-controlled studies of oveporexton (TAK-861), a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist, in narcolepsy type 1 (NT1). NT1 is caused by the loss of orexin-producing neurons in the brain. Orexin agonists are designed to address this underlying orexin deficiency. For the first time, this mechanism of action has been validated in Phase 3 studies demonstrating significant improvement across a broad range of symptoms. These results reinforce the potential of oveporexton to transform the standard of care. Oveporexton is a testament to Takeda's strength in discovering and developing a potential new class of medicines for difficult to treat diseases such as narcolepsy type 1. Share 'We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda's strength in discovering and developing a potential new class of medicines for difficult to treat diseases such as narcolepsy type 1,' said Christophe Weber, president and chief executive officer at Takeda. "Our leadership in orexin biology and building a multi-asset orexin franchise with transformative potential will position Takeda for long-term future growth.' The FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) studies were two large, global Phase 3 studies conducted in 19 countries. Both studies achieved statistically significant improvement compared to placebo with p-values of <0.001 for all primary and secondary endpoints across all doses at week 12. The primary and secondary endpoints measuring objective and patient reported improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions demonstrate statistically significant and clinically meaningful improvements achieving near normal ranges across the broad range of symptoms investigated. Oveporexton was generally well-tolerated with a safety profile from the Phase 3 studies overall consistent with oveporexton studies to date including the Phase 2b study. No serious treatment-related adverse events were reported. The most common adverse events were insomnia, urinary urgency and frequency. More than 95 percent of the participants who completed the studies enrolled in the ongoing long-term extension (LTE) study. 'We are grateful to the patients who took part in these clinical studies and to their families, the investigators and clinical staff. The studies were accelerated at an unprecedented pace with the aim to bring this potential treatment to people living with narcolepsy type 1 as quickly as possible,' said Andy Plump, M.D., Ph.D., president of R&D at Takeda. 'The comprehensive assessments from our Phase 3 studies build on the transformative results we saw with our Phase 2b study with most participants reaching normative ranges and reporting clinically meaningful improvement across a broad range of symptoms at the end of the 12-week treatment period. The positive results also reinforce the continued momentum for our late-stage pipeline, which we believe will deliver value to the patients we serve around the world.' Takeda intends to present the results at upcoming medical congresses and plans to submit a New Drug Application with the United States Food and Drug Administration and additional global regulatory authorities in fiscal year 2025. Results from the Phase 3 studies have no significant impact on the full year consolidated forecast for the fiscal year ending March 31, 2026. About Narcolepsy Type 1 (NT1) and Orexin Science NT1 is a chronic, rare neurological disease that results in a range of debilitating symptoms including excessive daytime sleepiness (EDS), cataplexy, disrupted nighttime sleep, sleep paralysis and hallucinations upon falling asleep or waking. Additionally, individuals living with NT1 often report cognitive symptoms, including difficulty thinking clearly, remembering, concentrating and paying attention. NT1 is caused by loss of the orexin-producing neurons in the brain, which regulate wakefulness and sleep, and is also believed to be essential to other functions such as attention through activation of orexin receptors. Currently, the standard of care is limited to symptomatic therapies that may only partially address some of the symptoms people face. About Oveporexton (TAK-861) Oveporexton (TAK-861) is an investigational orexin receptor 2 (OX2R)-selective agonist, which selectively stimulates the OX2R to restore signaling and address the underlying orexin deficiency that causes narcolepsy type 1 (NT1). By activating OX2Rs, oveporexton is designed to promote wakefulness and reduce abnormal rapid eye movement (REM)-sleep like phenomena, including cataplexy, to address the broad spectrum of daytime and nighttime symptoms. About the FirstLight and RadiantLight Phase 3 Studies FirstLight (TAK-861-3001; NCT06470828) and RadiantLight (TAK-861-3002; NCT06505031) are global, multicenter, placebo-controlled studies to evaluate the efficacy, safety and tolerability of oveporexton compared to placebo in patients with narcolepsy type 1 (NT1) over 12 weeks. The studies were conducted in 19 countries with enrollment completed within six months. The FirstLight study enrolled 168 participants randomized to one of three dosing arms (high dose, low dose and placebo). The RadiantLight study enrolled 105 participants randomized to two dosing arms (high dose and placebo). The primary endpoint in both studies was improvement in excessive daytime sleepiness (EDS) as measured by the Maintenance of Wakefulness Test (MWT), a standard measure of wakefulness. Key secondary endpoints included improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) and in the Weekly Cataplexy Rate (WCR), a measure evaluating cataplexy. The studies also evaluated the effect of oveporexton on participants' ability to maintain attention, participants' overall quality of life, the spectrum of narcolepsy symptoms and daily life functions, as well as the safety and tolerability of oveporexton. About Takeda's Orexin Agonists for Sleep-Wake Disorders Takeda is leading the field of orexin science with a multi-asset franchise. Orexin is a key regulator of sleep and wake patterns and contributes to other essential functions including attention, mood, metabolism and respiration. Oveporexton (TAK-861) is the lead investigational orexin receptor 2 (OX2R) agonist asset in Takeda's orexin franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 (NT1) from the U.S. Food and Drug Administration and the Center for Drug Evaluation of China's National Medical Products Administration. The company is also investigating other orexin agonists in populations with orexin levels in the normal range, including TAK-360, an oral OX2R agonist initially being investigated for the treatment of narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other potential indications where orexin signaling is implicated. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Important Notice For the purposes of this notice, 'press release' means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ('Takeda') regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as 'targets', 'plans', 'believes', 'hopes', 'continues', 'expects', 'aims', 'intends', 'ensures', 'will', 'may', 'should', 'would', 'could', 'anticipates', 'estimates', 'projects', 'forecasts', 'outlook' or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
Yahoo
08-07-2025
- Health
- Yahoo
Takeda Report Highlights Company's Commitment to Cutting-Edge Science, Putting Patients First
NORTHAMPTON, MA / / July 8, 2025 / Takeda is pleased to announce the publication of its 2025 Annual Integrated Report. The Report, available in both English and Japanese, sets out: How Takeda is investing in discovering and developing new, life-transforming treatments How the company is working with others to strengthen health care systems around the world And, how it's using new data and digital technologies to revolutionize drug discovery and development. The Report looks back on a successful FY2024 - a year of strong business performance and renewed confidence in the company's growth outlook. It also highlights Takeda's efforts to minimize its impact on the environment, support innovation and create a culture of lifelong learning for its approximately 50,000 employees worldwide. "We are enhancing efficiency, growth and resilience across our organization… I am confident that we have a sustainable business strategy that will serve patients, society and shareholders well in the years ahead." - Christophe Weber, Takeda President and Chief Executive Officer Highlights of Takeda's 2025 Annual Integrated Report Groundbreaking science In FY2024, Takeda invested USD 4.9 billion in research and development (R&D). Recent R&D investments have helped the company establish an exciting late-stage pipeline, with the potential to deliver significant value to both patients and Takeda in the coming years. These late-stage programs are backed up by the company's cutting-edge research organization and a highly innovative early- to mid-stage pipeline. Takeda's portfolio of Growth & Launch products, meanwhile, accounted for 48% of the company's revenue in FY2024. These products include ENTYVIO®, a treatment for ulcerative colitis and Crohn's disease, QDENGA®, Takeda's dengue fever vaccine, and FRUZAQLA®, used in the treatment of metastatic colorectal cancer. First approved in 2022, Qdenga® is now available to help combat rising cases of dengue fever in 29 countries worldwide. "In this line of work, you have to believe that cures are possible for both rare and more prevalent diseases. They're possible because we're living at a time of unparalleled scientific understanding and discovery." - Andy Plump, Takeda President of Research and Development Putting patients first Takeda is working to remove the many complex social barriers that can prevent people getting the treatment they need. That means helping train new health workers, improve prevention, screening and diagnosis, and provide financial assistance to patients who can't afford treatment. Currently, Takeda is working closely with governments and NGOs to strengthen health care systems in more than 80 Low- and Middle-income countries. At the same time, the company has partnerships with community organizations across the U.S., reaching nearly 11 million people in FY2024 - improving access to health care, as well as supporting better nutrition and vital education in Science, Technology, Engineering and Math. Since 2017, Takeda has enrolled 8,193 people in patient assistance programs in LMICs and countries with evolving health care systems, helping bridge the affordability gap for patients unable to afford prescribed medicines. Creating a digital pipeline Digital technology is transforming health care. Takeda is using more real-world and smart technologies like AI to bring better medicines to patients faster. In doing so, Takeda is creating a digital pipeline to mirror its R&D pipeline, making investments that will revolutionize the company's approach to developing, manufacturing and marketing its medicines and vaccines. In particular, the company sees more and more uses for AI - in everything from processing clinical trial data to identifying new efficiencies in its manufacturing. During the year, Takeda launched - a hub that brings together its AI initiatives - and which allows company teams to create and develop new prototypes in a controlled, secure "sandbox" environment. Takeda has 5 Innovation Capability Centers (ICCs) globally. With our ICCs, we're building many of own AI and GenAI models. Read More View additional multimedia and more ESG storytelling from Alerts on Contact Info:Spokesperson: AlertsWebsite: info@ SOURCE: Alerts View the original press release on ACCESS Newswire Sign in to access your portfolio
