VIFOR-PHARMA-GROUP
27.9.2021 08:04:09 CEST | Business Wire | Press release
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Kissei Pharmaceutical Co., Ltd., marketing authorization approval for TAVNEOS® for the treatment of patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), the two main types of ANCA-associated vasculitis, a rare and severe autoimmune renal disease with high unmet medical need.
“We are delighted that TAVNEOS® has been approved in Japan, the first market worldwide, and congratulate our partner Kissei for this significant milestone,” said Abbas Hussain, CEO of Vifor Pharma Group. “ANCA-associated vasculitis is officially designated an intractable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required. There is significant unmet medical need of over 10,000 patients in Japan, and we believe in the potential of TAVNEOS® for treating it. We are confident that Kissei will fully focus on bringing this breakthrough treatment to this patient population, helping them lead better, healthier lives.”
The approval is based on the marketing authorization application filing by Kissei which was supported by positive clinical data from the pivotal phase-III trial ADVOCATE in a total of 331 patients with MPA and GPA in 18 countries and regions, including Japan. TAVNEOS® demonstrated superiority over standard of care at week 52 based on Birmingham Vasculitis Activity Score (BVAS).
VFMCRP holds the rights to commercialize TAVNEOS® outside the U.S.. In June 2017, VFMCRP granted Kissei the exclusive right to develop and commercialize TAVNEOS® in Japan. Kissei expects to begin to market TAVNEOS® as soon as possible following NHI price listing. Outside Japan, TAVNEOS is currently in regulatory review with various agencies, including the U.S. Food and Drug Administration and the European Medicines Agency.
About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com .
About Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd. is a Japanese pharmaceutical company with approximately 70 years of history. Based on its management philosophy, “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees”, Kissei is concentrating on providing innovative pharmaceuticals to patients worldwide as a strongly R&D-oriented corporation. Kissei is engaged in R&D and licensing activities in the field of nephrology/dialysis, urology, and unmet medical needs in other disease areas. Kissei has an established collaboration with VFMCRP for sucroferric oxyhydroxide which Kissei fully developed in Japan as P-TOL® (known as Velphoro® in Europe/US) for the treatment of hyperphosphatemia. Since the launch in 2015, the market share of P-TOL® has been steadily expanding in Japan. For more information about Kissei Pharmaceutical, please visit www.kissei.co.jp .
About ChemoCentryx Inc.
ChemoCentryx is a biopharmaceutical company developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. Besides ChemoCentryx’s lead drug candidate, avacopan, ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.
About ANCA-associated vasculitis
ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.
About TAVNEOS® (avacopan)
Avacopan is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1. By precisely blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment, C5a on destructive inflammatory cells such as blood neutrophils, avacopan arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of inflammation. Moreover, avacopan’s selective inhibition of only the C5aR1 leaves the beneficial C5a l pathway through the C5L2 receptor functioning normally.
ChemoCentryx is also developing avacopan for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for ANCA-associated vasculitis, C3G and atypical hemolytic uremic syndrome. The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G. In October 2020, European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for avacopan for the treatment of patients with ANCA-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)).
View source version on businesswire.com: https://www.businesswire.com/news/home/20210926005078/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
The Estée Lauder Companies Fully Establishes Its “One ELC” Operating Model and Reaches Milestone in Its Profit Recovery and Growth Plan1.4.2026 23:00:00 CEST | Press release
WPP Appointed First-Ever Global Media Partner, Unifying Media Execution Worldwide“One ELC” Operating Model Is Transforming How the Company Operates at Scale The Estée Lauder Companies Inc. (NYSE: EL) today announced WPP as its first-ever global media partner, marking a significant advancement of its One ELC operating model, a scalable system designed to operate faster, execute with greater discipline, and drive growth. In fully establishing One ELC, the Company also reached a significant milestone in its Profit Recovery and Growth Plan’s (PRGP) Restructuring Program — a key action plan priority of Beauty Reimagined. Stéphane de La Faverie, President and Chief Executive Officer, The Estée Lauder Companies, said, “With the appointment of WPP as our first-ever global media partner, our One ELC operating model is now fully established. This more unified and scalable system will enable us to be faster, more agile and efficient, and support unlocking additional growth. Together with our exec
Visual Bank Expands “Qlean Dataset” to Support Large-Scale Japanese Speech Foundation Models1.4.2026 21:45:00 CEST | Press release
Delivering 100,000+ hours of rights-cleared Japanese audio, including regional dialects and culturally contextualized speech essential for commercial AI development. Visual Bank Inc. (CEO: Saneyuki Nagai), through its subsidiary amanaimages Inc., one of the largest digital asset providers for the marketing and advertising industry in Japan with over 40 years of history, today announced the expansion of its Qlean Dataset, a premium AI training data solution designed for developers building high-performance Japanese speech foundation models. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401752248/en/ Visual Bank Group, leveraging over 40 years of expertise through amanaimages Inc., expands Qlean Dataset, delivering high quality, rights cleared Japanese language corpora, including 100,000+ hours of commercially usable audio. A new development within the Qlean Dataset division, which focuses on providing datasets for institu
Manna Air Delivery Raises $50Million Series B as It Announces Plans to Expand in the United States1.4.2026 18:00:00 CEST | Press release
ARK Invest, backer of OpenAI, Anthropic, Tesla and SpaceX, the Ireland Strategic Investment Fund and Schooner Capital back new round bringing total funding to $110M Plans to scale to 40 bases in the United States, supported by seven years of operational orchestration experience, and recently expanded its global partnerships with Uber, joining Deliveroo, Just Eat and DoorDash in delivering everyday items by air. Manna Air Delivery, a global leader in consumer drone delivery, has announced a $50 million funding round to scale its proven operations further in the United States and Europe. The round brings Manna’s total funding to $110million. Manna now operates one of the most active consumer drone delivery networks in the world, with more than 250,000 regulated commercial UAV flights completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310714366/en/ Manna Air Delivery raises $50m Series B Investors in the round include
Bureau Veritas Launches an Independent AI Assessment Offering for European Enterprises, Developed in Partnership with Amazon Web Services (AWS)1.4.2026 17:45:00 CEST | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), announces the launch of an AI systems audit to help European enterprises assess and demonstrate their compliance with the European Union's "AI Act" regulatory requirements. This offering combines on-site audits, document analysis, and direct testing to deliver an independent maturity report. Since the EU's AI regulation came into force in 2024, companies have faced major implementation challenges. According to a recent report*, 68% of them struggle to interpret the provisions of the text, while 60% have yet to put in place the governance needed to comply. Non-compliance can cost them up to 7% of annual revenue. Bureau Veritas has developed this new audit offering to help companies identify their compliance gaps and remedy them. Bureau Veritas's new audit offering comprises a pre-audit, document review, on-site audit, and direct testing, resulting in an independent report on the client's AI maturit
Greenland Resources Signs Eight Year Off-take Agreement With SSAB to Supply High Quality Molybdenum1.4.2026 16:29:00 CEST | Press release
Greenland Resources Inc. (TSX:MOLY, FSE:M0LY) (“Greenland Resources” or the “Company”) is pleased to announce the Company has signed a binding off-take agreement with SSAB, a Nordic and US-based steel producer headquartered in Sweden. The company is a leading producer on the global market for advanced high-strength steels providing solutions to the defence, automotive, infrastructure and energy industries. A stock exchange press release from SSAB can be found on their website at www.ssab.com This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401270749/en/ The off-take agreement provides an established price floor and price ceiling and will allow SSAB to secure high quality low carbon emission ferromolybdenum extracted in Greenland and refined in Belgium. SSAB will be able to ensure a stable and responsibly sourced long term secured primary molybdenum supply with high sustainability standards and low scope 1&2 emissions from a
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom