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
Andersen Global tilføjer Andersen in Indonesia25.6.2026 22:21:00 CEST | Pressemeddelelse
Andersen Global styrker sin tilstedeværelse i Sydøstasien, da VDB Loi in Indonesia skifter navn til Andersen in Indonesia og dermed bliver det nyeste medlemsfirma, der tilslutter sig organisationen. Andersen in Indonesia yder skattemæssig og juridisk rådgivning til multinationale selskaber og udenlandske investorer, der er aktive på det indonesiske marked. Firmaet kombinerer årtiers markedserfaring med en praktisk tilgang, der fokuserer på at levere præcis og individuel rådgivning om komplekse regulatoriske og internationale forhold. "At blive en del af Andersen-brandet afspejler vores engagement i at give kunderne praktisk skattemæssig og juridisk rådgivning af høj kvalitet på grundlag af et bredere internationalt samarbejde," udtalte Tommy Hendharto Oetomo, administrerende partner for Andersen in Indonesia. "Kunder, der driver virksomhed i Indonesien, har brug for stadig mere koordineret støtte på tværs af landegrænser. At blive et medlemsfirma styrker vores evne til at levere den se
I-Pulse Signs Definitive Agreement with the U.S. Department of Commerce for $250 Million CHIPS R&D Award25.6.2026 20:53:00 CEST | Press release
■I-Pulse Will Develop Cutting-Edge Semiconductors that Support American Reindustrialization and National Security Goals■I-Pulse’s Technology Enables Cost-Competitive Development of America’s Vast Untapped Geothermal Energy Resources I-Pulse Co-founders Robert Friedland, CEO, and Laurent Frescaline, CTO, announced today a definitive agreement with the U.S. Department of Commerce’s CHIPS Research and Development Office for a $250 million award for the further development of I-Pulse’s proprietary semiconductor and pulsed power technology. “With today’s announced investment, the Trump administration is strengthening America’s capabilities and enhancing its national and energy security goals,” said Secretary of Commerce, Howard Lutnick. Co-founder Robert Friedland said: “We are excited to partner with the U.S. government to advance our unique, American technology suite to benefit our great nation. This award supports the development of world-leading critical components in the pulsed power t
Burjeel Holdings Prices First MENA Healthcare Sukuk Since 2018, 3.2x Oversubscribed25.6.2026 19:31:00 CEST | Press release
Burjeel Holdings, a leading super-specialty healthcare group in the GCC listed on the Abu Dhabi Securities Exchange, priced its inaugural USD 500 million Regulation S 5-year senior unsecured Sukuk offering due 2031 under its newly established USD 1.5 billion Senior Unsecured Sukuk Programme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625449702/en/ Burjeel Holdings’ inaugural Sukuk was priced at a 7.000 % profit rate and a yield of 7.125% (Photo: AETOSWire) The offering attracted significant demand from high-quality international and regional investors, with the orderbook peaking at USD 1.6 billion, representing 3.2x oversubscription. The strength of the orderbook enabled Burjeel to tighten pricing from initial price thoughts in the mid-7% area, with the Sukuk priced at a 7.000% profit rate and a yield of 7.125%, representing the lowest 5-year yield by a GCC-based private non-investment grade corporate issuer since 202
Fossil Fuels Are a Thing of the Past; The Future Is Renewable: The Smarter E Europe Concludes With a Clear Message25.6.2026 19:03:00 CEST | Press release
Packed halls, a vibrant atmosphere and a buzzing vibe – after three days, The smarter E Europe 2026, Europe’s largest alliance of exhibitions for the energy industry, has come to a successful close. The event held at Messe München offered a glimpse of a future-oriented energy world powered by renewables. A strong signal with a clear message went out to the world from the Bavarian capital: The future is renewable. Renewable energies can help ensure a reliable, secure and cost-effective energy supply around the clock, seven days a week. A total of 2,650 exhibitors from 52 countries – many of whom had expanded their booth space compared with the previous year – demonstrated how this can work. More than 66 percent of exhibitors were from outside of Germany. They presented innovative and market-ready products ranging from virtual power plants, smart grid and load control, smart charging solutions, storage technologies and PV hybrid systems to digital platforms transparently and flexibly.The
HeyGen Doubles to $200M ARR in Eight Months on the Rise of Identity-First AI Video25.6.2026 18:02:00 CEST | Press release
HeyGen, the identity-first AI video platform, today announced it has surpassed $200 million in annual recurring revenue, doubling in eight months. The milestone reflects a rapid shift in how individuals, small businesses, and enterprises adopt AI video: as a scalable layer for human communication across languages, formats, and audiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625305891/en/ HeyGen passes $200M in ARR HeyGen's community now spans more than 30 million users in 196 countries and 175+ languages & dialects, from solopreneurs creating professional social videos for the first time to 85% of the Fortune 100 — who together have created more than 118 million videos. That growth has come with rare capital efficiency: HeyGen generates roughly $2.70 in ARR for every dollar of equity capital raised, making it one of the most capital-efficient venture-backed AI companies in the world. "Crossing $200 million in AR
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