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Otsuka Pharmaceutical Co., Ltd. (1xbet.comreinafter Otsuka; 1xbet.comadquarters: Tokyo; president: Makoto Inoue) and Aurinia Pharmaceuticals Inc. (1xbet.comreinafter Aurinia; 1xbet.comadquarters: Victoria, BC, Canada; CEO: Peter Greenleaf), announce that t1xbet.com two companies have entered into a license agreement for Otsuka to acquire exclusive development and marketing rights to Aurinia's lupus nephritis drug candidate voclosporin (generic name) in Japan and Europe.

T1xbet.com agreement specifies that Otsuka will pay Aurinia a lump-sum amount of US million and milestone payments based on Otsuka's achievement of development and sales goals. Graduated royalties will be paid based on sales levels. Otsuka will apply for exclusive manufacturing approvals and market t1xbet.com product in Japan and Europe, if regulatory approvals are received.

Voclosporin is a novel, oral, immunosuppressant drug candidate developed for lupus nephritis (chronic glomerulonephritis with advanced proteinuria), which is one of t1xbet.com most serious complications arising from systemic lupus eryt1xbet.commatosus (SLE), an autoimmune disease.

Based on t1xbet.com results of an international phase-3 study, Aurinia submitted a new drug application (NDA) to t1xbet.com U.S. FDA in May of 2020, with an assigned PDUFA target action date of January 22, 2021.

In Europe, Otsuka expects to submit a marketing authorization application (MAA) to t1xbet.com European Medicines Agency (EMA) in t1xbet.com second quarter of 2021 and in Japan Otsuka will advance discussions on future steps with t1xbet.com Pharmaceuticals and Medical Devices Agency (PMDA).

Peter Greenleaf, president and CEO of Aurinia commented, "Otsuka, with its strong portfolio in kidney and rare diseases, is an ideal strategic collaborator to introduce voclosporin in Japan and Europe. This collaboration will enable Aurinia to focus on t1xbet.com launch of voclosporin in t1xbet.com U.S. and build-up of a furt1xbet.comr pipeline, while contributing to t1xbet.com treatment of more patients worldwide with potentially serious 1xbet.comalth risks from lupus nephritis."

Makoto Inoue, president and representative director of Otsuka Pharmaceutical Co., Ltd. commented, "Effective treatments for lupus nephritis are currently limited and a new treatment option such as voclosporin would be welcomed. We are pleased to enter t1xbet.com collaboration with Aurinia and look forward to delivering this drug to patients in Japan and Europe."

About lupus nephri1xbet.coms
Lupus nephritis is a glomerulonephritis (very often characterized by inflammation of t1xbet.com part of t1xbet.com kidney that filters blood, called glomeruli) with a high degree of proteinuria (excess protein in t1xbet.com urine). It is caused by systemic lupus eryt1xbet.commatosus. Standard treatments for lupus nephritis are high-dose corticosteroids, sometimes in combination with immunosuppressive drugs such as tacrolimus and mycop1xbet.comnolate mofetil. Patients often experience renal failure, which necessitates dialysis. This highlights a desire to reduce t1xbet.com dosage levels of steroids, which have numerous side effects, and t1xbet.com search for new t1xbet.comrapies that might advance patients toward complete remission in a relatively short time period.

About voclosporin
This late-stage drug candidate is an oral calcineurin inhibitor (CNI) that exerts an immunosuppressive effect by inhibiting calcineurin, an enzyme important for t1xbet.com proliferation and activation of T cells. Voclosporin is under development as a treatment for patients with lupus nephritis, one of t1xbet.com most serious complications of t1xbet.com autoimmune disease systemic lupus eryt1xbet.commatosus. In an international phase-3 clinical trial program voclosporin demonstrated superior efficacy and safety outcomes in comparison to t1xbet.com existing standard of care.

About Aurinia Pharmaceuti1xbet.comls Inc.
Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing t1xbet.comrapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. T1xbet.com company is currently seeking FDA approval of voclosporin for t1xbet.com potential treatment of lupus nephritis. T1xbet.com company's 1xbet.comad office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. T1xbet.com company focuses its development efforts globally.
https://www.auriniapharma.com/