Everest Medicines Announces European Commission Grants Approval of Kinpeygo® for Adults with Primary IgA Nephropathy to our Partner Calliditas Therapeutics
Everest Medicines announced that Calliditas Therapeutics has received conditional marketing authorization from the European Commission for Kinpeygo® (NEFECON) to treat primary IgA nephropathy (IgAN) in adults. This approval marks Kinpeygo as the first and only EMA-approved treatment for IgAN in Europe, essential for patients with a high risk of disease progression. The authorization is applicable across all 27 EU Member States and three additional countries. The approval is based on positive outcomes from the Phase 3 NefIgArd study, with a planned application for China in the second half of 2022.
- Kinpeygo is the first EMA-approved treatment for IgAN, addressing a significant unmet medical need.
- Approval covers all 27 EU Member States plus Iceland, Norway, and Liechtenstein, expanding market access.
- Positive Phase 3 study results support Kinpeygo's efficacy and safety, enhancing its market potential.
- None.
Kinpeygo® (developed under the name NEFECON) is the first and only EMA- approved treatment for IgAN
Everest Medicines has exclusive rights to develop and commercialize NEFECON in Greater China, Singapore and South Korea
SHANGHAI, July 17, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), announced today that our partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") has been granted conditional marketing authorization for Kinpeygo® (developed under the name NEFECON) by the European Commission for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
In Europe, Kinpeygo is an orphan medicinal product and the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than
"We are excited to receive the formal approval of Kinpeygo in the European Economic Area as the first and only EMA approved medication for this disease," said CEO Renée Aguiar-Lucander of Calliditas.
"We congratulate our partner Calliditas for making another major achievement to bring this first-in-disease therapy to more patients globally living with the chronic condition," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "Primary IgAN is more common in Asia than elsewhere in the world with even higher unmet demand for innovative treatment and we hope to make this important therapy available in our region soon."
The Kinpeygo approval is based on the efficacy and safety data of Part A of the NeflgArd pivotal Phase 3 study, an ongoing, randomized, double-blind, placebo-controlled, multicentre study conducted to evaluate Kinpeygo 16 mg once daily oral dose vs placebo in adult patients with primary IgAN.
Everest reported in April 2022 that the findings of reduction in proteinuria and stabilization of eGFR in a Chinese subpopulation after 9 months of treatment were in line with topline results from Part A of the NefIgArd study. These data will be included in planned New Drug Application for China in the second half of this year.
About NEFECON
NEFECON is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. NEFECON was designed as a 4 mg delayed release capsule and is enteric coated so that budesonide is released to the distal ileum. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
About Calliditas
Calliditas Therapeutics is a commercial stage biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product, developed under the name Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYOTM and conditional marketing authorization by the European Commission under the trade name KINPEYGO®.
Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
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