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
Vertex Presents New Data on ALYFTREK® at European Cystic Fibrosis Conference5.6.2026 18:00:00 CEST | Press release
- ALYFTREK Phase 3 data on children with cystic fibrosis ages 2 to 5 with vanzacaftor/tezacaftor/deutivacaftor-responsive genotypes including F/F and F/MF shows 65% reached sweat chloride levels of <30 mmol/L; Vertex on track to initiate global regulatory submissions in first half of 2026 - - Long-term 96-week interim analyses from two open-label extension studies demonstrate positive safety and efficacy profile of ALYFTREK in people with cystic fibrosis ages 6 and older -- Phase 3 data on TRIKAFTA® in children 1 to <2 years also presented; Vertex has initiated global regulatory submissions - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data demonstrating the potentially transformative impact of treating cystic fibrosis (CF) with ALYFTREK ® (vanzacaftor/tezacaftor/deutivacaftor) in children ages 2 to 5, as well as data from 96-week interim analyses of two open-label extension studies of ALYFTREK in children 6 to 11 years and people 12 years and older demonstrating
Owkin to Build AI Agents as Part of a Multi-Year K Pro Collaboration with Sanofi5.6.2026 13:00:00 CEST | Press release
Owkin, the agentic AI company pioneering Biological Artificial Superintelligence to transform drug discovery and development, today announced a multi-year collaboration with Sanofi to co-develop next-generation biopharma agents, to be backed by a five-year license for K Pro, Owkin’s AI Scientist. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260605704506/en/ K Pro, Owkin's AI scientist for biology, powered by multimodal patient data for smarter biopharma decision making. Owkin and Sanofi have collaborated since 2021 through a €90 million strategic partnership focused on target identification in oncology and patient subgrouping. The collaboration was later expanded to include drug positioning for Sanofi’s immunology pipeline. This new collaboration represents the next evolution in the partnership. During the five-year collaboration, Owkin will lead the end-to-end development of novel AI-driven biopharma agents purpose-built
DFNS Rebrands as the Core Banking Platform for Digital Assets5.6.2026 12:41:00 CEST | Press release
DFNS today announced a rebrand, marking its evolution from a wallet infrastructure to the first core banking platform for digital assets. The company is introducing a new logo, website, and market position as fintechs and institutions move their products and operations onchain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603859127/en/ Banks, fintechs, asset managers, trading firms, payment providers, market infrastructures, and clearing houses have stopped asking how to "add crypto." They're asking how to run financial products, controls, workflows, and client services on blockchain rails, with the reliability expected of core infrastructure. Some are going further still, exploring whether the blockchain can serve as the ledger itself, where an account is an onchain object rather than a row in a database. Where IBANs, virtual accounts, and blockchain wallets converge into one governed financial account. “DFNS was built
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.6.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to seventeen newly hired non-executive employees. The equity awards were granted on June 1, 2026 and consisted of options to purchase an aggregate of 157,000 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 74,700 shares. The options have an exercise price per share equal to $14.19, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restrict
Renewable Electricity, Soft Wheat Flour From Regenerative Agriculture, Initiatives to Support Local Communities: Barilla Shares These and Other Projects in “Stories of Sustainability.”5.6.2026 10:00:00 CEST | Press release
Barilla continues to advance its commitment to tastier products with less sugar and salt;An investment of 30 million euros in 2025 to quadruple photovoltaic capacity across plants, as part of a €168 million five-year plan focused on energy efficiency, renewable energy and sustainable water management.Barilla continues to expand regenerative agriculture practices across its global value chain, with over 816,000 tons of raw materials sourced through the Barilla Sustainable Farming program.4,000 tons of products donated worldwide and €2 million allocated to social causes in 2025, supporting communities across Barilla’s global footprint through food donations and social initiatives. A slimmer Tagliatelle pack that saves 150 tons of cardboard and cuts transport-related CO₂ emissions by 20%1; ready-made sauce jars made with around 65% recycled glass; the progressive scaling of regenerative agriculture practices across Barilla’s value chain and initiatives supporting inclusion and equal oppor
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