AUPH Aurinia Pharmaceuticals Inc
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Voclosporin - AURORA
Lupus
|
PDUFA priority review
PDUFA priority review
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Voclosporin ophthalmic solution (VOS) - AUDREY
Dry eye syndrome
|
Phase 2/3
Phase 2/3
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Phase 2/3 trial did not meet primary endpoint - November 2, 2020. Development to be suspended.
|
|
Voclosporin
Focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD)
|
Phase 2
Phase 2
|
Phase 2 trial ongoing.
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Latest News
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Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the management team will participate in two upcoming virtual investor conferences and participate in a panel discussion hosted by Dr. Scott Gottlieb, former FDA Commissioner:
- H.C. Wainwright Virtual BioConnect 2021 Conference. On-demand fireside chat available beginning Monday, January 11, 2021 at 6:00 a.m. EST;
- Scott Gottlieb, M.D. Hosts a Panel Discussion on Clinical Trials with Neil Solomons, M.D., Chief Medical Officer of Aurinia, during the H.C. Wainwright BioConnect 2021 Conference on Monday, January 11, 2021 at 12:00 p.m. EST; and
- J.P Morgan 39th Annual Healthcare Conference. Fireside chat to be hosted on Thursday, January 14, 2021 at 4:30 p.m. EST.
In order to listen to the audio webcast, interested parties can register and access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available for 30 days on Aurinia's website.
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 lupus nephritis (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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210108005055/en/
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- Aurinia to receive $50 million U.S. upfront payment in addition to up to $50 million U.S. in regulatory and reimbursement milestone payments -
- Agreement includes royalties of up to 20 percent on net sales payable to Aurinia -
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.
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- State-of-the-Art Monoplant Will Provide Cost and Production Efficiency and Secure Active Pharmaceutical Ingredient (API) Supply for Future Commercial Demand -
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia") and Lonza Ltd. (SIX: LONN) ("Lonza") today announced they have expanded their exclusive manufacturing relationship. The parties entered into a collaborative agreement to build a dedicated manufacturing capacity within Lonza's existing small molecule API facility in Visp, Switzerland. The dedicated facility (also referred to as "monoplant") will be equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacture of voclosporin, while expanding existing capacity and providing supply security to meet future commercial demand.
The new agreement builds on the parties' successful multi-year relationship. The agreement, which is conditional upon U.S. regulatory approval of voclosporin, does not impact the launch supply for voclosporin as this is secured by existing inventory. The monoplant is estimated to be operational in 2023.
"Lonza's world-class expertise and partnership have helped Aurinia to cost-effectively optimize the unique and complex manufacturing process required for the synthesis of voclosporin," said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. "We are currently well-poised and ready with adequate product supply for launch and anticipated market demand. A dedicated production capability will help keep our manufacturing costs down and ensure long-term flexibility to meet future demand for years to come."
"This collaboration is a great example of how we can support both early and commercial-stage biopharmaceutical companies through innovation in manufacturing technology and flexible business models," said Gordon Bates, President Small Molecules Division, Lonza. "We are looking forward to further developing our relationship with Aurinia into a long and productive collaboration to supply this innovative medicine to patients across the globe."
Following U.S. regulatory approval of voclosporin, Aurinia will commence several capital expenditure payments. Upon completion of the monoplant, Aurinia will have the right to maintain unobstructed use of the monoplant by paying a quarterly fixed facility fee.
The U.S. Food and Drug Administration (FDA) accepted the filing of Aurinia's NDA for voclosporin in the treatment of lupus nephritis (LN), granted Priority Review, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021.
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 systemic lupus erythematosus (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. Voclosporin is now under review by the FDA with Fast Track status and Priority Review as a potential therapy for LN in the United States.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 Lonza
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at www.lonza.com and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.
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: equipment at the monoplant facility being state-of-the-art; Aurinia expecting future commercial demand for voclosporin; the monoplant being operational by 2023; Aurinia being poised for increased adoption of and increased need for voclosporin; the PDUFA target action 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: monoplant buildout occurring on anticipated timelines; 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; and that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though 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 development and commercialization of voclosporin; and the monoplant may have operational issues once underway that could result in production being limited or reduced from anticipated capacities; the monoplant could be subject to delays in construction, or construction may not be completed at all; the market for voclosporin for use in LN may not be as anticipated. 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.
Additional Information and Disclaimer (Lonza)
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited ("SGX-ST"). Lonza Group Ltd is not subject to the SGX-ST's continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.
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Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference. Presentations will be available for registered attendees via the Piper Sandler conference site through December 3.
In order to listen to the audio webcast, interested parties can register and access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available for 30 days on Aurinia's website.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201202005231/en/
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Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company, today announced that the Company's Compensation Committee granted the newly appointed Executive Vice President, General Counsel, Corporate Secretary & Chief Compliance Officer, Stephen Robertson, a non-qualified stock option to purchase an aggregate of 298,924 common shares on November 16, 2020. The option has a per share exercise price of $13.40 USD, the closing trading price on November 13, 2020. One-third of the shares underlying the option vest in November 2021, and the balance of the shares vest in a series of 24 equal monthly installments thereafter. The inducement option was granted as an inducement material to the new employee entering into employment with Aurinia in accordance with Nasdaq Listing Rule 5635(c)(4). For the purposes of TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as Nasdaq.
The inducement stock option also has a ten-year term and is subject to the terms and conditions of the stock option agreement pursuant to which the option was granted.
About Aurinia
Aurinia Pharmaceuticals is a late clinical-stage 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 developing the investigational drug, voclosporin, for the treatment of lupus nephritis. The Company's head office is in Victoria, British Columbia and focuses its development efforts globally. For further information, see our website at www.auriniapharma.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201120005658/en/