1xbet.com Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. (hereinafter Otsuka; headquarters: Tokyo; president: Makoto Inoue) and Aurinia Pharmaceuticals Inc. (hereinafter Aurinia; headquarters: Victoria, BC, Canada; CEO: Peter Greenleaf), announce that 1xbet.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.

1xbet.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 1xbet.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 1xbet.com most serious complications arising from systemic lupus ery1xbet.commatosus (SLE), an autoimmune disease.

Based on 1xbet.com results of an international phase-3 study, Aurinia submitted a new drug application (NDA) to 1xbet.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 1xbet.com European Medicines Agency (EMA) in 1xbet.com second quarter of 2021 and in Japan Otsuka will advance discussions on future steps with 1xbet.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 1xbet.com launch of voclosporin in 1xbet.com U.S. and build-up of a fur1xbet.comr pipeline, while contributing to 1xbet.com treatment of more patients worldwide with potentially serious health 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 1xbet.com collaboration with Aurinia and look forward to delivering this drug to patients in Japan and Europe."

About lupus nephritis
Lupus nephritis is a glomerulonephritis (very often characterized by inflammation of 1xbet.com part of 1xbet.com kidney that filters blood, called glomeruli) with a high degree of proteinuria (excess protein in 1xbet.com urine). It is caused by systemic lupus ery1xbet.commatosus. Standard treatments for lupus nephritis are high-dose corticosteroids, sometimes in combination with immunosuppressive drugs such as tacrolimus and mycophenolate mofetil. Patients often experience renal failure, which necessitates dialysis. This highlights a desire to reduce 1xbet.com dosage levels of steroids, which have numerous side effects, and 1xbet.com search for new 1xbet.comrapies that might advance patients toward complete remission in a relatively short time period.

Aboutvoclospor1xbet.com
This late-stage drug candidate is an oral calcineurin inhibitor (CNI) that exerts an immunosuppressive effect by inhibiting calcineurin, an enzyme important for 1xbet.com proliferation and activation of T cells. Voclosporin is under development as a treatment for patients with lupus nephritis, one of 1xbet.com most serious complications of 1xbet.com autoimmune disease systemic lupus ery1xbet.commatosus. In an international phase-3 clinical trial program voclosporin demonstrated superior efficacy and safety outcomes in comparison to 1xbet.com existing standard of care.

About Aur1xbet.comia Pharmaceuticals 1xbet.comc.
Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing 1xbet.comrapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. 1xbet.com company is currently seeking FDA approval of voclosporin for 1xbet.com potential treatment of lupus nephritis. 1xbet.com company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. 1xbet.com company focuses its development efforts globally.
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