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Vifor Pharma AG has announced that the Commercial Court St. Gallen has legally canceled all publicly held registered shares of Vifor. The last trading day for these shares on the SIX Swiss Exchange is
CSL Vifor and Fresenius Kabi announced the approval of Ferinject® by China's National Medical Products Administration (NMPA) for treating iron deficiency in adults. This approval is significant given the high prevalence of iron deficiency anemia in China, affecting approximately 15% of the population. Ferinject® has marketing authorization in 85 countries and is expected to launch in H1 2023. The drug may enhance patient blood management in hospitals, as approximately 3-4 million patients undergo elective surgery annually.
Vifor Pharma AG announced a decision approved by SIX Exchange Regulation AG on October 19, 2022, extending exemptions from various disclosure and publicity obligations until February 28, 2023. This includes not publishing the Half-Year Report 2022 and other management disclosures, except notifications regarding the delisting date. These exemptions remain valid unless specific legal actions occur related to minority shareholders. If such events arise, the issuer's obligations would immediately revive.
SIX Exchange Regulation has approved the delisting of all registered shares of
The European Medicines Agency (EMA) has accepted the Conditional Marketing Authorization (CMA) application for sparsentan, a treatment for IgA nephropathy (IgAN)
If approved, sparsentan will be a first-in-class non-immunosuppressive therapy addressing a significant unmet need in Europe. The application is supported by positive interim results from the PROTECT Study, showing a 49.8% reduction in proteinuria compared to 15.1% in controls, indicating strong efficacy.
U.S. District Court for the District of Delaware ruled in favor of Vifor Fresenius Medical Care Renal Pharma (VFMCRP), confirming that Teva Pharmaceuticals infringes the patent for Velphoro (sucroferric oxyhydroxide). This ruling protects VFMCRP's formulation patent, set to expire in July 2030. Previous disputes with other ANDA filers regarding Velphoro have been settled, allowing them to launch generics on agreed dates. VFMCRP is actively defending its intellectual property to sustain its market position.
Kapruvia® (difelikefalin) has received approval from the Swiss Agency for Therapeutic Products for treating chronic kidney disease (CKD)-associated pruritus in hemodialysis patients. This follows approvals from agencies in the U.S., Canada, and Europe. The approval is backed by positive results from pivotal phase-III trials, including KALM-1 and KALM-2, and 32 supportive studies. Regulatory decisions in Australia and Singapore are anticipated soon. The therapy aims to address a significant unmet medical need for those suffering from moderate-to-severe pruritus, potentially improving their quality of life.
Vifor Fresenius Medical Care Renal Pharma announces that NICE has recommended Tavneos® for treating severe granulomatosis polyangiitis (GPA) and microscopic polyangiitis (MPA) in adults in England, Wales, and Northern Ireland. This oral therapy follows MHRA authorization in May 2022. Clinical trials showed Tavneos® met primary endpoints, offering a new treatment option with a favorable safety profile. The launch is expected shortly, marking a significant advancement in addressing the unmet medical needs of AAV patients.
CSL Limited has received all regulatory approvals for the acquisition of Vifor Pharma AG, with settlement set for 9 August 2022. CSL expects to acquire over 97% of Vifor shares post-settlement and plans to delist Vifor. Hervé Gisserot will become General Manager of Vifor upon settlement. CEO Paul Perreault emphasized the acquisition's strategic importance, enhancing CSL's capabilities in rare disease treatment. Vifor's CEO Abbas Hussain expressed confidence in the future within CSL's global framework, allowing for accelerated growth and product launches.
CSL Limited (ASX: CSL; USOTC: CSLLY) announced a further postponement of its public tender offer for all publicly held registered shares of Vifor Pharma Ltd. The settlement, originally set for July 22, 2022, is now extended until September 30, 2022, due to unmet offer conditions regarding merger clearances. This delay follows an initial postponement announced on March 28, 2022. Additionally, CSL has filed for the cancellation of the remaining publicly held Vifor shares.
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