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  5. Formation of a Licensing Agreement Covering Japan and Europe for the Lupus Nephritis Drug "Voclosporin"

December 17, 2020

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Formation of a Licensing Agreement Covering Japan and Europe for the Lupus Nephritis Drug "Voclosporin"

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 the 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.

The agreement specifies that Otsuka will pay Aurinia a lump-sum amount of US $50 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 the 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 the most serious complications arising from systemic lupus erythematosus (SLE), an autoimmune disease.

Based on the results of an international phase-3 study, Aurinia submitted a new drug application (NDA) to the 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 the European Medicines Agency (EMA) in the second quarter of 2021 and in Japan Otsuka will advance discussions on future steps with the 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 the launch of voclosporin in the U.S. and build-up of a further pipeline, while contributing to the 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 the 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 the part of the kidney that filters blood, called glomeruli) with a high degree of proteinuria (excess protein in the urine). It is caused by systemic lupus erythematosus. 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 the dosage levels of steroids, which have numerous side effects, and the search for new therapies 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 the proliferation and activation of T cells. Voclosporin is under development as a treatment for patients with lupus nephritis, one of the most serious complications of the autoimmune disease systemic lupus erythematosus. In an international phase-3 clinical trial program voclosporin demonstrated superior efficacy and safety outcomes in comparison to the existing standard of care.

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


Information in this news release was current as of the original release date.

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