Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) has announced the signing of a collaboration and license agreement with Otsuka Pharmaceutical Co. Ltd. The agreement is for the oral voclosporin development and commercialization for Lupus Nephritis treatment in the EU, Japan, Russia, Switzerland, the UK, Ukraine, Belarus, Norway, and Liechtenstein.
Aurinia to received $50 million upfront
According to the agreement, Otsuka will pay Aurinia an upfront cash fee of $50 million with the potential of regulatory and reimbursement milestone payments of up to $50 million. Equally, Aurinia will get tiered royalties that range between 10% and 20% on net sales alongside additional milestones based on Otsuka meeting certain annual sales.
Voclosporin is a proprietary, experimental, and orally administered drug developed by Aurinia for the treatment of lupus nephritis. LN is a progressive, chronic kidney inflammation that is among the most severe complications of systemic lupus erythematosus (SLE).
This agreement will leverage Otsuka’s renowned expertise in rare kidney disease to show Aurinia’s commitment to expanding voclosporin’s access globally for LN treatment. Otsuka will file a marketing authorization application with the EMA in the second quarter of 2021 with voclosporin filing for LN with Japan’s Pharmaceutical Medical Devices Agency expected at a later date. Currently, the drug is under review with the US FDA with a Prescription Drug User Fee Act target action date expected on January 22, 2021.
Otsuka ideal Voclosporin commercialization partner
Peter Greenleaf, Aurinia Pharmaceuticals’ CEO and President said that Otsuka is an ideal partner for the commercialization of voclosporin in Japan and Europe owing to its strong capabilities in rare disease and nephrology. The partnerships will give Aurina more non-dilutive funds for the successful launch of voclosporin in the US. Greenleaf said that the funds will also support the company in building its pipeline and ensuring access to the potentially life-saving treatment. Otsuka Pharmaceuticals’ president Makoto Inoue said that currently only a few treatments are available for LN treatment and a new medication such as voclosporin is very welcome. Makoto said that they are delighted to partner with Aurinia and they look forward to bringing the drug to patients in Europe and Japan.
