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Aurinia Announces Licensing Partner Otsuka Filed Initial Marketing Authorization Application for Voclosporin with the European Medicines Agency
Tuesday, July 6, 2021Company Profile | Follow Company
Aurinia Announces Licensing Partner Otsuka Filed Initial Marketing Authorization Application (MAA) for Voclosporin with the European Medicines Agency (EMA)
Victoria, BC, July 6, 2021--(T-Net)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) 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.
About Aurinia
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.
Forward-Looking Statements
Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the estimated proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; and the accuracy of reported data from third party studies and reports. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.
Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following difficulties: we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; and the results from our clinical studies and from third party studies and reports may not be accurate. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.
All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent annual report on Form 10-K available by accessing the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar or the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com.
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