Policy & Regulation
Calliditas Therapeutics signs licensing agreement with Everest Medicines to develop and commercialise Nefecon for IgA Nephropathy in Greater China and Singapore
11 June 2019 -

Specialty pharmaceutical company Calliditas Therapeutics AB (Calliditas) (STO:CALTX) and Everest Medicines II Limited (Everest Medicines) announced on Monday the entering into a license agreement to develop and commercialise Calliditas' leading drug candidate Nefecon in Greater China and Singapore for the chronic autoimmune kidney disease IgA Nephropathy (IgAN).

Under the terms of the agreement, Calliditas will receive an initial upfront payment of USD15m on signing of the agreement, as well as future payments linked to pre-defined development, regulatory and commercialisation milestones up to an additional USD106m, including an option worth up to USD20m for the development of Nefecon in other potential indications. Everest will also pay typical royalties on net sales.

Calliditas is currently running a pivotal, global phase 3 clinical trial with Nefecon for the treatment of patients with IgAN. This agreement gives Everest Medicines exclusive rights to develop and commercialise Nefecon in China, Hong Kong, Macau, Taiwan and Singapore and may, depending on the outcome of consultation with the relevant regulatory authorities, lead to the inclusion of

Chinese study centres in the ongoing pivotal study, NefIgArd , with the result of achieving registration approval for the Chinese market on an accelerated basis.

Following potential registration approvals, Everest will be responsible for the commercialization of Nefecon in the relevant territories.

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, following which Calliditas will submit the applications for accelerated/conditional regulatory approval to the US Food and Drug Administration and the European Medicines Agency respectively.

Torreya acted as exclusive financial advisor to Calliditas on the transaction.

Everest is a biopharmaceutical company focused on developing and commercialising transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets.

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