NY-VIFOR/AMERICAN-REGENT
20.12.2021 07:02:08 CET | Business Wire | Press release
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211219005059/en/
AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR
Vifor Pharma Group and its partner American Regent, Inc., a Daiichi Sankyo Group company, today announced that they have reached settlement agreements with Mylan Laboratories Ltd., and Sandoz, Inc., that resolve the patent litigation brought in response to Abbreviated New Drug Applications seeking approval by the U.S. Food and Drug Administration to market a generic version of Injectafer® .
Under the terms of the settlements, Vifor Pharma and American Regent will grant Mylan Laboratories Ltd., and Sandoz, Inc., licenses to market generic ferric carboxymaltose products in the United States beginning 1 July 2026 (subject to U.S. FDA approval). Details of all settlements are confidential.
“We are pleased to have settled all outstanding patent litigations regarding Injectafer® ,” commented Dr. Oliver P. Kronenberg, Group General Counsel of Vifor Pharma. “With these agreements in place, we can continue to focus on addressing the significant remaining unmet medical need to diagnose and appropriately treat iron deficiency anemia to improve lives of U.S. patients, together with our partner American Regent.”
“Injectafer® is an important treatment option for patients with iron deficiency anemia”, said Gretchen Fritz, Chief Legal Officer of American Regent. “American Regent is proud of the innovation and decades of hard work that made this treatment option possible and available to patients in the U.S. We are pleased to resolve the burdens of litigation, and excited for future results of our ongoing robust clinical program for Injectafer® .”
In the US, more than 1.7 million patients have been treated for iron deficiency anemia. Injectafer® has been studied in more than 40 clinical trials that included over 8,800 patients worldwide. Injectafer® has been approved in 83 countries since initial European Union (EU) approval in 2007 and is the most extensively studied intravenous iron.
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 American Regent, Inc.
American Regent, Inc., a Daiichi Sankyo Group company, is a top-10 injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For nearly 20 years, we have been a leader in IV iron therapy. American Regent is committed to U.S.-based manufacturing. In 2018, more than 99% of units supplied were formulated, filled, and finished at our U.S.-based facilities, making us uniquely positioned to quickly mobilize to respond to shortages or changes in market needs. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, please visit www.americanregent.com
.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211219005059/en/
Link:
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