Swedish pharmaceutical company Calliditas Therapeutics AB said on Friday that it plans to develop and commercialise its leading drug candidate Nefecon in Greater China and Singapore for the chronic autoimmune kidney disease IgA Nephropathy (IgAN) under a license agreement with Everest Medicines II Limited.
IgA nephropathy (IgAN), also known as Berger's disease, is the most common form of glomerulonephritis, a chronic inflammatory condition of the kidney.
Nefecon is a proprietary oral formulation of budesonide, designed to deliver the acive ingredient to the ileum where the Peyer's patches, which harbour the majority of B-cells producing IgA antibodies, are found, reported the company.
Currently, Calliditas is conducting a pivotal, global Phase 3 clinical trial with Nefecon for the treatment of patients with IgAN. Everest Medicines has the exclusive rights to develop and commercialise Nefecon in China, Hong Kong, Macau, Taiwan and Singapore and may lead to the inclusion of Chinese study centres. The first 200 randomised patients in the ongoing pivotal NefIgArd study will form the basis for topline data readout expected to occur during the second half of 2020.
At signing, Calliditas will receive an initial upfront payment of USD15m from Everest
Pursuant to the agreement, Calliditas future payments linked to pre-defined development, regulatory and commercialisation milestones up to an additional USD106, including an option worth up to USD20 for the development of Nefecon in other potential indications. In conjunction, Everest will pay typical royalties on net sales.
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