Latest news with #Astellas'
Yahoo
11-07-2025
- Business
- Yahoo
Pfizer and Astellas' Xtandi improves OS as combination therapy
Pfizer and Astellas' Xtandi (enzalutamide) has improved overall survival (OS) in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC), but only as a combination therapy. First approved in 2012, the prostate cancer therapy met the secondary endpoint of OS in the Phase III EMBARK trial (NCT02319837) when combined with leuprolide, compared to placebo plus leuprolide, in patients with nmHSPC with biochemical recurrence (BCR) and high risk for metastasis. Despite this, while a favourable trend was observed, there was no statistical significance between Xtandi monotherapy and placebo or leuprolide. In the trial, patients were randomised across three arms: Xtandi plus leuprolide, placebo plus leuprolide, or Xtandi alone. This update comes two years after the companies announced the trial met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with Xtandi plus leuprolide versus placebo plus leuprolide. Although Pfizer and Astellas have not yet disclosed additional details about the OS data, they stated that full results will be presented at an upcoming medical meeting. They also noted that safety results were consistent with the known safety profile of Xtandi. Carolina Urologic Research Center's medical director Dr Neal Shore said: 'These data demonstrate that treatment with Xtandi can extend life for men with nmHSPC and high-risk BCR who have relapsed after initial curative-intent therapy with prostatectomy, radiation therapy or both, further validating EMBARK's metastasis-free survival (MFS) data. "While men with nmHSPC with high-risk BCR now have expanded treatment choices, these results demonstrate a clear clinical benefit, including both MFS and OS, supporting the clinical practice of initiating Xtandi for these patients.' Xtandi is currently approved in more than 80 countries, including the US, Europe and Japan. The US Food and Drug Administration (FDA) approved Xtandi for use in nmHSPC with high-risk BCR in November 2023, based on the EMBARK trial meeting its primary endpoint. The European Commission (EC) granted a label expansion for its use in the same patient population in April 2024. GlobalData predicts the prostate cancer market will be worth $22.62bn in 2030. Xtandi sales are set to start dropping due to the drug's patent expiring in 2026 in Europe and 2027 in the US. As a result, GlobalData predicts that sales of Xtandi will reach $5.59bn in 2025 and will drop to $2.24bn in 2030. The pharmaceutical industry is facing one of the most significant patent cliffs of the decade, with major companies preparing for substantial revenue losses, according to market analysts. A recent GlobalData report projects a sharp decline in the proportion of global drug sales protected by patents, with the figure expected to drop to just 4% by 2030. This compares to 12% in 2022 and 6% in 2024. GlobalData is the parent company of Clinical Trials Arena. "Pfizer and Astellas' Xtandi improves OS as combination therapy" 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
Yahoo
11-07-2025
- Business
- Yahoo
Pfizer and Astellas' Xtandi improves OS as combination therapy
Pfizer and Astellas' Xtandi (enzalutamide) has improved overall survival (OS) in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC), but only as a combination therapy. First approved in 2012, the prostate cancer therapy met the secondary endpoint of OS in the Phase III EMBARK trial (NCT02319837) when combined with leuprolide, compared to placebo plus leuprolide, in patients with nmHSPC with biochemical recurrence (BCR) and high risk for metastasis. Despite this, while a favourable trend was observed, there was no statistical significance between Xtandi monotherapy and placebo or leuprolide. In the trial, patients were randomised across three arms: Xtandi plus leuprolide, placebo plus leuprolide, or Xtandi alone. This update comes two years after the companies announced the trial met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with Xtandi plus leuprolide versus placebo plus leuprolide. Although Pfizer and Astellas have not yet disclosed additional details about the OS data, they stated that full results will be presented at an upcoming medical meeting. They also noted that safety results were consistent with the known safety profile of Xtandi. Carolina Urologic Research Center's medical director Dr Neal Shore said: 'These data demonstrate that treatment with Xtandi can extend life for men with nmHSPC and high-risk BCR who have relapsed after initial curative-intent therapy with prostatectomy, radiation therapy or both, further validating EMBARK's metastasis-free survival (MFS) data. "While men with nmHSPC with high-risk BCR now have expanded treatment choices, these results demonstrate a clear clinical benefit, including both MFS and OS, supporting the clinical practice of initiating Xtandi for these patients.' Xtandi is currently approved in more than 80 countries, including the US, Europe and Japan. The US Food and Drug Administration (FDA) approved Xtandi for use in nmHSPC with high-risk BCR in November 2023, based on the EMBARK trial meeting its primary endpoint. The European Commission (EC) granted a label expansion for its use in the same patient population in April 2024. GlobalData predicts the prostate cancer market will be worth $22.62bn in 2030. Xtandi sales are set to start dropping due to the drug's patent expiring in 2026 in Europe and 2027 in the US. As a result, GlobalData predicts that sales of Xtandi will reach $5.59bn in 2025 and will drop to $2.24bn in 2030. The pharmaceutical industry is facing one of the most significant patent cliffs of the decade, with major companies preparing for substantial revenue losses, according to market analysts. A recent GlobalData report projects a sharp decline in the proportion of global drug sales protected by patents, with the figure expected to drop to just 4% by 2030. This compares to 12% in 2022 and 6% in 2024. GlobalData is the parent company of Clinical Trials Arena. "Pfizer and Astellas' Xtandi improves OS as combination therapy" 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.
Irish Post
29-06-2025
- Business
- Irish Post
Japanese pharmaceutical company Astellas to invest €129m in its Irish operations
JAPANESE pharmaceutical company Astellas has revealed it will invest €129m in its Irish operations over the next three years. The multi-site investments, focusing on development, sustainability and Research Development & Innovation (RD&I), aim to enhance Astellas' operations across the country. Lisa Murphy, General Manager of Astellas Pharma, said the investment is a testament to 'the great relationship that Astellas has with the local community and local officials'. Proposals One of Japan's largest life sciences companies and a leading developer and manufacturer of pharmaceutical products, Astellas has a heritage in Ireland spanning more than 35 years. The company currently employs in excess of 650 people across two facilities in Killorglin, Co. Kerry and Mulhuddart, Co. Dublin. The proposed investment, supported by IDA Ireland, reinforce Astellas' long-term commitment to Ireland as a strategic hub for its global manufacturing, research and development activities. The investment will see Astellas Killorglin implement several initiatives to significantly reduce energy consumption and CO₂ emissions. In Dublin, the company is embarking on a project to improve environmental sustainability through the installation of solar panels and heat pumps across multiple facilities. Meanwhile, a new Tralee facility due to be fully operational in 2028 will create 120 new jobs and will accelerate the expansion of Astellas' in-house production capabilities. Speaking about the proposals, Ms Murphy said: "We're delighted to see great progress across the various projects ongoing across the Astellas' operational footprint here in Ireland. "The continued investment by Astellas in Ireland will expand our capacity and capabilities for aseptic drug products, reinforce stable production for global supply, and accelerate the development and commercialisation of innovative antibody drugs and other new products." 'Key location' Peter Burke, Minister for Enterprise, Tourism and Employment, recently met with members of the Astellas senior leadership team in Tokyo. Speaking from the city, he said: "This commitment by Astellas highlights Ireland's role in the global life sciences sector. "Our ongoing investment in education, infrastructure and innovation continues to create the optimum environment for companies to thrive. "Astellas' decision to grow its footprint in both Kerry and Dublin demonstrates the strength of Ireland's offering and our commitment to supporting enterprise development across all regions." Michael Lohan, CEO of IDA Ireland, said the news showed that Ireland continues to attract strategic investments from world-leading companies. "Astellas' long-standing presence here and its ongoing commitment to both Dublin and Kerry is a testament to the strength of our partnership and the value Ireland offers as a key location for innovation and growth," he added. See More: Astellas, Dublin, Kerry, Killorglin, Mulhuddart
Irish Independent
25-06-2025
- Business
- Irish Independent
Astellas invest €129 million in its Kerry and Irish operations
Astellas is currently building a new €330 million facility in Tralee and has an existing facility in Killorglin. It is one of Japan's largest life sciences companies and a leading developer and manufacturer of pharmaceutical products globally. Minister Foley welcomed the investment in its Irish operations in Kerry and Dublin over the next three year. Astellas is starting the process of building a new drug product fill facility in Tralee, creating 120 new jobs. Additionally, more than 500 workers will be involved in the construction phase. The new facility will accelerate the expansion of Astellas' in-house production capabilities and ensure a stable supply of high-quality medicines to patients around the world. The facility will also be fully digitally enabled and will adhere to high energy and environmental standards. 'I'm really pleased to welcome this multi-million euro investment by Astellas, supported by the Government through IDA Ireland,' Minister Foley said. 'This is a real boost of confidence, in addition to the €330 million invested for a state-of-the-art facility in Tralee and the fantastic existing facility in Killorglin. It is a great, positive story for all involved. Thank you to Astellas for their unstinting commitment to Kerry,' she added. Astellas say it will undertake a comprehensive plan to equip employees in Tralee with skills to address strategic challenges, focusing on leadership development, digital literacy, environmental sustainability, innovation, and compliance. The company will set up a research and development project in Tralee to enhance the production of antibody-drug conjugates and monoclonal antibodies, aiming to establish a high-efficiency, low-waste, multi-product biologics facility. Moreover, Astellas will have a Green Capital project in Tralee to reduce energy use and lower CO₂ emissions. The planned upgrades include heating, ventilation and air conditioning systems, a woodchip boiler, solar panels, and an on-site wastewater treatment plant. Astellas Killorglin will implement several initiatives to significantly reduce energy consumption and CO₂ emissions. These measures include wind turbines, woodchip boiler economisers, chiller upgrades, BioLPF/HVO tanks, water heat pumps, and energy metering systems. Speaking from Tokyo, Minister for Enterprise, Trade and Employment, Peter Burke, who met with members of the Astellas senior leadership team, stated that the announcement by Astellas highlights Ireland's role in the global life sciences sector. 'Our ongoing investment in education, infrastructure, and innovation continues to create the optimum environment for companies to thrive. Astellas' decision to grow its footprint in both Kerry and Dublin highlights the strength of Ireland's offering and our commitment to supporting enterprise development across all regions,' he said.
Irish Independent
19-06-2025
- Business
- Irish Independent
Astellas celebrates significant award wins for sustainability efforts
Just last month, Astellas was awarded Sustainable BioPharmaChem Company of the Year at the inaugural BioPharmaChem Impact Awards, in recognition of the company's efforts in implementing sustainable and responsible practices in the biopharmachem industry. The awards were held by BioPharmaChem Ireland (BPCI), the Ibec group that represents the biopharmaceutical and chemical sectors in Ireland. In March, Astellas picked up the Commitment to Sustainability Award at the well-known IDA supported Invest in Ireland Awards. These awards reward excellence in the inward foreign direct investment sector in the Republic of Ireland. Astellas won the award in recognition of the environmental and sustainability stewardship the judges felt was at the heart of Astellas' operations. The awards acknowledged Astellas' significant investment in renewable energy, waste reduction and greener manufacturing practices which contributed to its win on the night. Astellas also enjoyed huge success at the Green Awards in February. With 140 companies submitting 280 entries to compete across 29 categories, Astellas received four awards on the night. These included Green Large Organisation of the Year, Sustainability Team of the Year, the Green Lifesciences Award and the Sustainable Energy Achievement Award. Speaking about the award wins, Louis Collins, Executive Director and Site Lead, Astellas Co. Ltd. said: 'Our strong culture of sustainability has been embedded in everything we do since the early 2000s. We're hugely aware of the role our work plays in patients' lives and the communities we operate in. With that in mind, our sustainability approach incorporates all of our key stakeholders, from patients and our community to our employees, with the understanding that our continued growth and success needs to be achieved as sustainably as possible. Through a range of initiatives and ongoing investment in renewable technologies, Astellas Kerry now meets 74% of its energy needs from renewable sources. Since 2005, we have achieved a 98% reduction in CO₂ emissions and a 70% reduction in the generation of non-hazardous waste. These award wins are a clear demonstration that our operations reflect our commitments to our stakeholders.'
