On Dec. 15, 2020, Aurinia Pharmaceuticals announced the funding and initiation of an open-label exploratory trial evaluating the antiviral effects of voclosporin in kidney transplant recipients with COVID-19 (SARS-CoV-2) – the VOCOVID study.

Organ transplant recipients who contract COVID-19 are at greater risk for complications due to the requirement of daily immunosuppressive medications to prevent organ rejection. Calcineurin inhibitors (CNIs), like voclosporin, have been shown in prior in vitro studies to inhibit viral replication.

The dedicated facility (also referred to as “monoplant”) will be equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacture of voclosporin, while expanding existing capacity and providing supply security to meet future commercial demand.

The new agreement builds on the parties’ successful multi-year relationship. The agreement, which is conditional on regulatory approval of voclosporin, does not impact the launch supply for voclosporin as this is secured by existing capacity. The monoplant is estimated to be operational in 2023.

Following U.S. regulatory approval of voclosporin, Aurinia will commence several capital expenditure payments. Upon completion of the monoplant, Aurinia will have the right to maintain unobstructed use of the monoplant by paying a quarterly fixed facility fee. The U.S. Food and Drug Administration (FDA) accepted the filing of Aurinia’s NDA for voclosporin in the treatment of lupus nephritis (LN), granted Priority Review, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021.