Business Wire

Aurinia Announces Collaboration and Licensing Agreement with Otsuka Pharmaceutical Co., Ltd. for the Development and Commercialization of Voclosporin in Europe and Japan

Share

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of oral voclosporin for the treatment of Lupus Nephritis (LN) in the European Union (EU), Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

As part of the agreement, Aurinia will receive an upfront cash payment of $50 million U.S. and has the potential to receive up to $50 million U.S. in regulatory and reimbursement milestone payments. Aurinia will receive tiered royalties ranging from 10 to 20 percent (dependent on achievement of sale milestones) on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka.

Voclosporin is a novel, investigational, orally administered treatment developed to treat patients with LN, a chronic, progressive inflammation of the kidneys that is one of the most serious complications of the autoimmune disease systemic lupus erythematosus (SLE).

The agreement leverages Otsuka’s well-recognized expertise in rare kidney diseases to underscore Aurinia’s commitment to expanding global access to voclosporin for the treatment of LN. Otsuka expects to file a marketing authorization application (MAA) with the European Medicines Agency (EMA) in Q2 2021 and will also manage the filing of voclosporin for LN with Pharmaceuticals Medical Devices Agency (PDMA) in Japan at a later date. Voclosporin is currently under review with the U.S. Food and Drug Administration (FDA) with an assigned Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021.

“Otsuka, with strong capabilities in nephrology and rare disease, is an ideal strategic partner to introduce voclosporin in Europe and Japan,” says Peter Greenleaf, President and Chief Executive Officer, Aurinia Pharmaceuticals. “This collaboration will provide Aurinia with additional non-dilutive funds to focus on the successful U.S. launch of voclosporin and support plans to build our pipeline, while ensuring more lupus nephritis patients around the world can benefit from this potentially life-saving medication.”

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
LN is an inflammation of the kidney caused by SLE and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder. The disease is highly heterogeneous, affecting a wide range of organs and tissue systems. Unlike SLE, LN has straightforward disease outcomes, where an early reduction in proteinuria correlates with positive long-term outcomes. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced eGFR, and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.

About Voclosporin
Voclosporin is a novel therapy in development for patients with LN, an inflammation of the kidney which is one of the most serious complications of the autoimmune disease SLE. If left untreated, LN can lead to irreversible kidney damage, kidney failure or even death. Through an extensive clinical program, voclosporin has demonstrated superiority to the standard-of-care for LN.

About Aurinia
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 LN. 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.

About Otsuka
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd., based in Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13 billion in 2019.

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en.

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: the Company receiving up to $50 million U.S. in regulatory and reimbursement milestone payments; the Company receiving tiered royalties ranging from 10 to 20 percent (dependent on achievement of sale milestones) and additional milestone payments based on annual sales by Otsuka; Otsuka filing an MAA with the EMA in Q2 2021; plans to build the Company’s pipeline; the agreement with Otsuka ensuring more LN patients around the world benefit from voclosporin; and the Company’s anticipated PDUFA date of January 22, 2021. 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 regulatory and reimbursement milestones will be achieved and the milestones payments made; and the FDA will not alter the PDUFA date; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable including approval of marketing authorization applications and new drug approvals, as well as favourable product labeling; and that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of other parties. 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: Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; the regulatory, reimbursement and sales milestones may not be achieved. 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.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release 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 Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

We seek safe harbour.

Contact information

Investor Contact:
Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia
gschulman@auriniapharma.com

Media Contacts:
Dana Lynch
Corporate Communications, Aurinia
dlynch@auriniapharma.com

Stefan Riley
Ten Bridge Communications
stefan@tenbridgecommunications.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Servier announce updated overall survival results of exploratory TASCO1 phase II study of LONSURF ® + bevacizumab in a first-line setting for patients with unresectable mCRC non-eligible for intensive therapy16.1.2021 22:15:00 CETPress release

Servier announced today updated results from the exploratory phase II TASCO1 study evaluating LONSURF® (trifluridine/tipiracil) + bevacizumab and capecitabine + bevacizumab (C-B) in a first-line setting for patients with unresectable metastatic colorectal cancer (mCRC) who are non-eligible for intensive therapy.1 The data were announced today during an oral presentation at the 2021 ASCO Gastrointestinal Cancers Symposium (ASCO-GI). Patients with mCRC who are not eligible for chemotherapy face a large unmet need, with fewer treatment options available to them and lower survival rates. Colorectal cancer (CRC) makes up 9.7% of total global cancer cases, with almost 1.4 million new cases of CRC each year.2 In Europe, CRC is the second most common cause of death due to cancer, and those with a metastatic disease have a 5-year survival rate of just 11%.3 “For patients with metastatic colorectal cancer, those non-eligible for standard combination therapy have few options left and we are conti

H.I.G. Realty Invests in Production Studios & Content Hub in Madrid15.1.2021 09:00:00 CETPress release

H.I.G. Capital, LLC ("H.I.G."), a leading global alternative investment firm with $43 billion of equity capital under management, announced today that one of its affiliates has invested in Madrid Content City, an approximately 140,000 square meter hub with state of the art audio-visual facilities, including production studios, production & post-production technical facilities, and a university focused on media studies. H.I.G. continues to add to its sizeable portfolio of real estate assets across Europe, consisting of both equity as well as debt investments, with a particular focus on its target market of value-added small and midcap opportunities. Riccardo Dallolio, Managing Director and Head of H.I.G. Europe Realty Partners, commented: “Madrid Content City will benefit from strong secular tailwinds underpinned by the boom in content production. The state-of-the-art studios and related facilities, the exceptional multinational tenant line-up with long term leases, and its critical mas

Eurofins, the global leader in analytical testing, expands worldwide face mask testing & certification capabilities15.1.2021 07:30:00 CETPress release

Since the start of the pandemic Eurofins (Paris:ERF) has tested thousands of models of surgical and hygienic masks and provided best-in-class speed and certification for PPEs globally, enabling these critical products to get market as fast as possible. Eurofins has developed global leading testing capabilities and certification services in the North America, Europe and Asia ensuring that PPE manufacturers are able to provide the indispensable support needed in the fight against the coronavirus. As of today, Eurofins is one of the few GLP certified and ISO/IEC 17025 accredited laboratory networks to fully cover all testing requirements for surgical/medical and hygienic masks by the FDA, EU regulations and many international and country-specific directives and guidelines such as CEN, CE Marking, ISO, ASTM or OECD. Our robust portfolio for masks includes globally accepted, safety and performance testing, virucidal, bacterial filtration, particle filtration, differential pressure, biocompa

TOXINS 2021: New analyses of pivotal Phase III trial data highlight long duration of response for Dysport ® (abobotulinumtoxinA) in five therapeutic indications15.1.2021 07:00:00 CETPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced results from new analyses of pivotal Phase III clinical trial data to assess treatment intervals over repeat cycles of Dysport® (abobotulinumtoxinA [aboBoNT-A]) in five patient populations. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations is being shared during the TOXINS 2021 conference, which is taking place virtually between 16-17 January 2020 and is organized by the International Neurotoxin Association.1-28 Ipsen is sharing 26 abstracts during the congress, with data including updates from the recently published surveys into the experience of patients and caregivers, data from the Phase IV ULIS-III trial, and ten abstracts focused on basic science research into neurotoxins.1-27 Spasticity is one of the most common and disabling conditions associated with many neurological conditions in adults and is characterized by velocity-dependent muscle hypertonia. Spasticity can lead to disabilit

Velodyne Lidar Commends NHTSA Plan to Update NCAP14.1.2021 21:58:00 CETPress release

Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today commended the U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA) plan to update to its New Car Assessment Program (NCAP). The NHTSA proposal would add four advanced driver assistance system (ADAS) capabilities to the NCAP, keeping pace with evolving safety technologies and providing much-needed information to consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005992/en/ Images show vehicle with lidar-based PAEB stopping before adult target @ 50% overlap (above) and vehicle with camera and radar-based PAEB crashing into adult target (below). (Photo: Velodyne Lidar, Inc.) NCAP is the U.S. Government’s premier consumer information program for evaluating vehicle safety performance. The NHTSA proposal to add ADAS technologies to the NCAP includes pedestrian automatic emergency braking, lane keeping support, blind spot warning and

Snow Software Recognized as a 2020 Gartner Peer Insights Customers’ Choice for Software Asset Management14.1.2021 20:39:00 CETPress release

Snow Software, the global leader in technology intelligence, today announced that the company was named a December 2020 Gartner Peer Insights Customers’ Choice for Software Asset Management (SAM) Tools. Gartner defines software asset management tools as technology that “automates many of the tasks required to maintain compliance with software licenses, thereby controlling software spending.” This is the fourth Gartner Peer Insights Customers’ Choice announcement for SAM, and Snow has earned the distinction all four times. Based solely on feedback from verified customers, Gartner Peer Insights Customers’ Choice reflects reviews and ratings published within the last 12 months. Snow received 100 reviews – the most of any vendor in the market – with an overall rating of 4.6 out of 5 as of January 12, 2021. Earlier this year, Snow was recognized as a Leader in Gartner’s 2020 Magic Quadrant for Software Asset Management Tools1 and received the highest scores in three out of four use cases in

Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 202014.1.2021 19:15:00 CETPress release

Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)i, and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe. "Despite the global challenges in 2020, Veristat continued to advance its mission of helping clients achieve regulatory approval of novel medical therapies," stated Patrick Flanagan, Chief Executive Officer at Veristat. "Now, more than ever, Veristat is focused on providing expert guidance to facilitate the rapid approval for therapies that improve the lives of patients and their families around the world." Ve

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom