Aurinia Announces Licensing Partner Otsuka Filed Initial Marketing Authorization Application (MAA) for Voclosporin with the European Medicines Agency (EMA)
- Category: Proteins and Peptides
- Published on Friday, 25 June 2021 18:34
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VICTORIA, Canada & ROCKVILLE, MA, USA I June 25, 2021 I Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the Company) announced today that the Company’s licensing partner, Otsuka Pharmaceutical Europe Ltd. (OPEL), filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA). LN is a complication of the autoimmune disease systemic lupus erythematosus (SLE) that seriously impacts the kidneys. In January 2021, the U.S. Food and Drug Administration (FDA) approved voclosporin in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN and it is currently available in the U.S. under the brand name LUPKYNIS™.
In December 2020, Aurinia entered into a collaboration and licensing agreement with OPEL for the development and commercialization of voclosporin for the treatment of LN in the European Union, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. Once the MAA is approved, OPEL would be authorized to market voclosporin in the European Union, Norway, Iceland, and Liechtenstein. As part of the agreement, Aurinia received a $50 million U.S. upfront cash payment with the potential to secure up to $50 million U.S. in additional regulatory and reimbursement milestone payments. In addition, Aurinia will receive tiered royalties ranging from 10 to 20 percent, dependent on net and annual sales following commercialization, along with additional milestone payments based on the attainment of certain annual sales by OPEL. Voclosporin will be provided to OPEL under a cost-plus supply agreement.
“Lupus nephritis is a serious, complex condition that historically has lacked dedicated, approved treatment options,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. “We look forward to continuing to work with Otsuka to expand access to voclosporin and provide patients and physicians access to this new therapy that addresses a significant unmet need in lupus nephritis.”
About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. Approximately one out of three of these individuals with SLE will develop LN. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.
Aurinia Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company’s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
SOURCE: Aurinia Pharmaceuticals