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
SBC Medical Announces Pricing of Secondary Public Offering of 3.1 Million Shares of Common Stock20.4.2026 01:07:00 CEST | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“the Company”), a Management Service Organization operating a wide range of franchise businesses across diverse medical fields, today announced the pricing of the underwritten secondary public offering of 3,100,000 shares of the Company’s common stock by Dr. Yoshiyuki Aikawa (the “Selling Stockholder”) at the public offering price of $3.25 per share. Additionally, the Selling Stockholder has granted the underwriters a 45-day option to purchase up to an additional 465,000 shares of the Company’s common stock. The offering is expected to close on or about April 21, 2026, subject to customary closing conditions. The Company is not selling any shares of its common stock in the offering. The Selling Stockholder will receive all of the proceeds from the offering. Maxim Group LLC is acting as the sole book-running manager and Roth Capital Partners is acting as the co-manager for the offering. The offering is being made pursuant to the Com
Horse Powertrain Reveals X-Range C15 Direct Drive Powertrain for Hybridizing BEV Platforms20.4.2026 01:01:00 CEST | Press release
Horse Powertrain, a global leader in innovative and low-emission powertrain systems, will unveil a new ‘all-in-one’ powertrain at Beijing Auto Show 2026: the X-Range C15 Direct Drive. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260419640202/en/ Left-facing view of the HORSE X-Range C15 Direct Drive The ultra-compact X-Range C15 Direct Drive integrates a full hybrid powertrain – including a 4-cylinder engine, transmission, power electronics, and an electric motor – into a single compact unit with a shared housing, designed to mount to the rear subframe enabling a double isolated installation for best NVH. The X-Range C15 Direct Drive is designed as an ‘all-in-one’ powertrain to replace the rear electric drive unit of an existing BEV platform. It enables an automaker to use a single shared platform for their BEV, HEV, PHEV, and REEV lineups without any significant changes to vehicle design or production environments. The ne
Compass Pathways Commends White House Executive Order to Accelerate Research and Access for Psychedelic Treatments18.4.2026 22:12:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, welcomes the White House Executive Order on accelerating medical treatments for serious mental illness. “We commend the Administration’s Executive Order on psychedelic treatment which recognizes the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have,” said Kabir Nath, CEO at Compass Pathways. “Today’s announcement aligns regulatory urgency with patient need, and we applaud the Administration for taking this important step forward in accelerating access, without compromising rigorous science. Compass is conducting the largest, most robust classic psychedelic studies to date with COMP360 synthetic psilocybin. We have recently reported two positive phase 3 trials in treatment-resistant depression (TRD) with highly statistically significant and clinically meaningful data that
2026 NAB Show Opens Tomorrow, Uniting Global Media Leaders to Shape the Future of Storytelling18.4.2026 04:08:00 CEST | Press release
CEO of Zhong, one of YouTube’s most-watched creators with 70 million subscribers and 95 million followers on all platforms, joins program The 2026 NAB Show kicks off Saturday, April 18, with the show floor and exhibits opening on April 19, highlighting the most innovative companies and bringing together the world’s most influential voices across media, entertainment and technology for the industry’s premier global event. As the only platform that convenes broadcasters, media companies, content creators and technology innovators at scale, NAB Show continues its century-long legacy as the catalyst for innovation, growth and deal-making in a rapidly evolving, multi-platform world. From artificial intelligence and the creator economy to sports, streaming and cloud transformation, NAB Show is where the tools, talent and ideas driving the future of storytelling converge. “NAB Show is where the global media ecosystem comes together not just to explore what’s next—but to build it,” said Karen
Philip Morris International Announces U.S. FDA Reauthorization of IQOS as a Modified Risk Tobacco Product17.4.2026 23:43:00 CEST | Press release
A pioneer in smoke-free tobacco products, Philip Morris International is the only company that has received modified risk tobacco product authorizations for heated tobacco products.In their order, FDA concluded that: “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals” The U.S. Food and Drug Administration (FDA) announced that it has authorized the renewal of modified risk tobacco product (MRTP) orders previously granted to PMI for two versions of the IQOS device and three variants of the tobacco consumables, commercialized under the HEETS brand. This renewal allows PMI to continue sharing reduced-exposure information with U.S. adults 21+ who use traditional tobacco products, such as combustible cigarettes. The agency concluded that renewing the IQOS and HEETS MRTP authorizations is appropriate to promote public health and is expected to benefit th
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