Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) disclosed Friday that its licensing partner Otsuka has submitted an initial Marketing Authorization Application (MAA) for voclosporin for the cure of lupus nephritis (LN) to the European Medicines Agency (EMA). LN is a problem of the autoimmune disease systemic lupus erythematosus (SLE) that badly affects the kidneys.
Previously, the U.S. FDA authorized voclosporin in conjunction with a background immunosuppressive therapy regimen for the cure of adult sufferers with active LN in January 2021. It is currently available in the U.S. under the brand name LUPKYNIS. Moreover, Aurinia inked into cooperation and licensing agreement with OPEL for the development and commercialization of voclosporin for the cure of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine in December 2020.
Furthermore, Once the MAA is authorized, OPEL would be permitted to market voclosporin in the European Union, Norway, Iceland, and Liechtenstein. As part of the contract, Aurinia got a $50 million U.S. upfront cash payment with the possibility to obtain up to $50 million U.S. in further regulatory and reimbursement milestone payments.
Additionally, Aurinia will obtain multiple-level royalties varying from 10 to 20 percent, reliant on the net and annual sales after commercialization, along with further milestone payments based on the achievement of certain yearly sales by OPEL. Voclosporin will be supplied to OPEL under a cost-plus supply agreement.