About Us | ScientistAUPH Aurinia Pharmaceuticals Inc
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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LUPKYNIS (Voclosporin) - AURORA-2
Lupus Nephritis
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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LUPKYNIS (Voclosporin)
Lupus
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Approved
Approved
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FDA Approval announced January 22, 2021.
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Voclosporin ophthalmic solution (VOS) - AUDREY
Dry eye syndrome
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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.
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Latest News
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Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its second quarter 2021 financial results on Thursday, August 5, 2021, after the markets close. Aurinia's management team will also host a conference call at 4:30 p.m. EDT to discuss the Company's financial results and to provide a general business update.
The conference call and webcast is scheduled for August 5, 2021 at 4:30 p.m. ET. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.
ABOUT AURINIA
Aurinia Pharmaceuticals 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 has introduced LUPKYNIS™ (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210726005060/en/
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Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company), a commercial stage biopharmaceutical company advancing therapies for severe autoimmune diseases, announced today it will voluntarily delist the common shares of the Company from the Toronto Stock Exchange (TSX) effective as of the close of trading on July 30, 2021. The Company's common shares will no longer be traded on the TSX but will continue to trade on the Nasdaq Capital Market (Nasdaq) under the symbol AUPH.
Trading on the Nasdaq accounted for approximately 94 percent of Aurinia's daily trading volume over the past 12 months. Therefore, the Company believes that the trading volume of its shares on the TSX no longer justifies the expense and administrative efforts associated with maintaining a dual listing. The Company is confident that the transition to a single listing will help deliver better value to its shareholders, employees and of course, the patient and HCP communities it serves. Pursuant to Sec. 720(b) of the TSX Company Manual, shareholder approval is not required as an acceptable alternative market exists for the listed securities.
Most brokers in Canada, including discount and online brokers, have the ability to buy and sell securities listed on Nasdaq. Therefore, the Company's Nasdaq listing will continue to provide shareholders with the same accessibility to trade the Company's common shares. The value of investor shares or stock options is not related to or dependent on the TSX listing. Shareholders holding shares or options in Canadian brokerage accounts should contact their brokers to confirm how to trade the Company's shares on the Nasdaq.
About Aurinia
Aurinia Pharmaceuticals 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210716005457/en/
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Five patient organizations will receive funds to implement plans aimed at reducing health disparities, connecting people living with systemic lupus erythematosus (SLE) and lupus nephritis (LN) with needed health management resources
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the Company) today announced the recipients of five $50,000 grant awards to support implementation patient navigation programs targeted toward disadvantaged populations at most risk of developing SLE and LN. Each non-profit patient-focused organization will receive funds to support their proposed one-year pilot programs with the goal of helping people living with these conditions to navigate the complexities of diagnosis and disease management, support better adherence to medical appointments and treatments, and provide customized resources and education.
"The RFP process was competitive, and we were pleased to receive so many thoughtful and creative submissions for this first-ever Aurinia initiative," said Christine Lindsay, Vice President, Professional and Advocacy Relations. "The five recipients were awarded grants based on their demonstrated ability to collaborate with key lupus centers, rheumatologists, and nephrologists, their ability to measure program outcomes, and ultimately, provide individualized support to underserved populations."
Navigation programs will be launched in the following cities:
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Atlanta, Georgia
Lupus Foundation of America Georgia Chapter in collaboration with the Grady Lupus Clinic -
Brooklyn, New York
The Health Science Center of Brooklyn Foundation in collaboration with SUNY Downstate Health Sciences University -
Cleveland, Ohio
Lupus Foundation of America Ohio Chapter in collaboration with the Ohio Department of Health -
Indianapolis, Indiana
Lupus Foundation of America Indiana Chapter in collaboration with Eskenazi
Hospital, Lupus Clinic, and Indiana University Hospital -
Philadelphia, Pennsylvania
Lupus Foundation of America Tri-State Chapter in collaboration with Temple University Hospital Lupus Program
"The need for a patient navigator program at our institution, and many like ours, is enormous. It has long been recognized that racial and ethnic characteristics influence outcome in patients with SLE. Black (African American and Afro-Caribbean) and Hispanic SLE patients have more severe disease than white patients, with higher mortality and a more rapid accrual of irreversible damage," says Ellen M. Ginzler MD, MPH, Vice Chair for Research, Department of Medicine Chief, Rheumatology Division, SUNY Downstate Health Science University. "We are pleased and honored to work with The Health Science Center of Brooklyn Foundations to implement a student-led navigator program and to work to reduce health disparities, stressing early diagnosis, and providing compassionate high quality care to immigrant, at-risk, and underserved individuals."
"Twenty years ago, very few spoke of lupus. There was little awareness and understanding of the signs and symptoms and very little investment in research. We have made great progress, but we must do more as we have lost too many too early of all ages, and we cannot rest," states Sam Lim, MD, MPH, Professor of Medicine and Epidemiology, Emory University, Chief of Rheumatology – Grady Health System, and Director of the Grady Lupus Clinic. "We are eager to work with the Lupus Foundation of America, Georgia chapter, to implement a patient navigator program that will mitigate the barriers to health equity by improving patient adherence to treatment, provider-patient communication, patient mental and physical health, and, most importantly, outcomes."
Aurinia funded patient navigator programs launch on July 1 and grant recipients will convene regularly to share lessons learned, best practices, and community needs that can be addressed through navigation services throughout the 1-year grant period.
About systemic lupus erythematosus (SLE) and lupus nephritis (LN)
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210630005174/en/
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Atlanta, Georgia
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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.
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.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONSLUPKYNIS 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.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.
CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.
Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.
ADVERSE REACTIONS
The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.
SPECIFIC POPULATIONS
Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210625005139/en/
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Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) announced today the appointment of Dr. Brinda Balakrishnan, M.D., Ph.D., to the Company's Board of Directors effective June 14, 2021. Dr. Balakrishnan is Group Vice President, Corporate and Business Development of BioMarin Pharmaceutical Inc. ("BioMarin"), a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare disorders. At BioMarin, Dr. Balakrishnan leads initiatives on corporate strategy, mergers and acquisitions, partnering and licensing.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210614005185/en/
Dr. Brinda Balakrishnan, newly appointed Director to the Aurinia Pharmaceuticals Board. (Photo: Business Wire)
"On behalf of the entire Company, it is an honor to welcome Dr. Balakrishnan to Aurinia's Board of Directors," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "With her rich experience in medicine, biotech business development and the rare disease space, we are eager to leverage her input and insights as we continue in our mission to support and better treat people suffering with rare, autoimmune diseases, including lupus nephritis."
"I am delighted to join the Board of Directors of Aurinia," said Dr. Balakrishnan. "The Company is at an exciting moment in its evolution, and I look forward to working with the Board and management team as Aurinia continues on its mission to serve people suffering from debilitating autoimmune diseases."
Dr. Balakrishnan has been at BioMarin since 2016. Prior to joining BioMarin, Dr. Balakrishnan was the co-founder and Vice President of corporate strategy and product development at Vision Medicines, Inc., a start-up focused on developing treatments for rare ophthalmic diseases. Before Vision Medicines, she spent two years as a consultant at McKinsey & Company in the healthcare practice, serving clients across small biotech, large pharma, and healthcare provider groups on topics related to corporate strategy, corporate and business development, and operations. Prior to McKinsey, Dr. Balakrishnan was in business development at Genzyme.
Dr. Balakrishnan earned a B.S. degree from the Massachusetts Institute of Technology (MIT) in chemical engineering and a Ph.D. from MIT in biomedical engineering and chemical engineering. She also earned her M.D. degree from Harvard Medical School and conducted her medical training in internal medicine at Beth Israel Deaconess Medical Center in Boston, a Harvard hospital.
About Aurinia
Aurinia Pharmaceuticals 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210614005185/en/