Voclosporin

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), announced today the acceptance of six abstracts, including five poster presentations, at the American Society of Nephrology (ASN) Kidney Week 2024 taking place in San Diego, CA October 23-27. These data reinforce the clinical importance of LUPKYNIS ® (voclosporin), a second generation calcineurin inhibitor (CNI), for the treatment of adults with active lupus nephritis (LN). “The data featured at ASN elucidate the critical role LUPKYNIS plays in advancing the treatment of lupus nephritis, especially in populations disproportionately impacted by the disease. We’re particularly excited about moving our ENLIGHT-LN™ registry forward, as clinicians need insights into real-world treatment patterns. Additionally, we continue adding to our growing body of evidence that the unique mechanism of action of LUPKYNIS affects podocytes, resulting in significant impact on kidney health in adults with active LN,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia. New real-world baseline data from ENLIGHT-LN, a U.S.-based prospective, observational registry of adult patients with LN treated with LUPKYNIS This initial analysis of baseline data from 123 patients with biopsy-confirmed LN who are initiating or have initiated treatment with LUPKYNIS within the last 12 months provides a critical foundation for understanding the real-world effectiveness and usage patterns of LUPKYNIS. The subset of patients includes high percentages of Black and Hispanic and/or Latino patients, reflecting the larger population of LN in the US and the communities disproportionately affected by lupus and LN. Two new studies uncover the potential effects of LUPKYNIS on podocytes in LN and idiopathic nephrotic syndrome compared to older treatments A new study explored the impact of cyclosporine A (CsA), tacrolimus (TAC), and LUPKYNIS on podocyte cell biology and biomechanics. Using an integrative approach that combined classical cell biological assay with transcriptomics, quantitative proteomics, and other analyses, the study found that all three therapies modulate podocyte cytoskeletal architecture, but LUPKYNIS enhanced podocyte cytoskeletal stability at lower concentrations than CsA and TAC. Another study investigated the effects of LUPKYNIS in a preclinical model of idiopathic nephrotic syndrome. Results showed that LUPKYNIS significantly improved proteinuria, reduced hypercoagulability, enhanced lipid pro and showed significantly better cell viability and cytoskeletal integrity, in comparison to CsA. Together, these findings highlight the important role that LUPKYNIS plays in preserving kidney function and provide further evidence differentiating LUPKYNIS from first-generation calcineurin inhibitors. Following is the complete guide to Aurinia’s accepted abstracts at ASN 2024: Title: Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States Authors: Niloofar Nobakht, Laura B. Geraldino-Pardilla, Leanna M. Wise, Mohammad Kamgar, Lily Cipolla, Lucy S. Hodge, Keelin Dahl Date: Thursday, October 24, 2024 Time: 10:00 a.m. – 12:00 p.m. PT Poster Number: TH-PO653 Title: Disease Targeting Properties of Voclosporin in Renal Transplant and Lupus Nephritis Patients Authors: Simon Zhou, Linda M. Rehaume, Ernie Yap, Henry Leher, Lucy Hodge, Robert B. Huizinga Date: Thursday, October 24, 2024 Time: 10:00 a.m. – 12:00 p.m. PT Poster Number: TH-PO642 Title: Immunologic Changes Over Time in Repeat Kidney Biopsies from the AURORA Studies of Voclosporin in Lupus Nephritis Authors: Samir V. Parikh, Maddalena Bolognesi, Ivana Grbesa, Brad H. Rovin, Giorgio Cattoretti, Vincenzo L’Imperio, Arnon Arazi, Lucy S. Hodge, Ernie Yap Date: Friday, October 25, 2024 Time: 10:00 a.m. – 12:00 p.m. PT Poster Number: FR-PO839 Title: Integrative Systems Analyses Reveal Calcineurin Inhibitor-Mediated Control of Human Podocyte Biophysics and Physiology Authors: Jacob M. Wright, Anthony Mendoza, Jonathan C. Haydak, Jenny Wong, Linda M. Rehaume, Kirk N. Campbell, Evren U. Azeloglu, Maria Paola Santini Date: Saturday, October 26, 2024 Time: 10:00 a.m. – 12:00 p.m. PT Poster Number: SD-PO549 Title : Voclosporin Ameliorates Proteinuria and Directly Protects Podocytes in a Model of Non-Inflammatory Glomerular Disease Authors: Yu Kamigaki, Julie A. Dougherty, Amanda P. Waller, Katelyn J. Wolfgang, Linda M. Rehaume, Jennifer L. Cross, Laura E. Biederman, Zackary S. Stevenson, Eman Abdelghani, Bryce A. Kerlin, William E. Smoyer Date: Saturday, October 26, 2024 Time: 10:00 a.m. – 12:00 p.m. PT Poster Number: SA-PO709 Title : Characterization of Screening Patterns and Identification of Patients with Lupus Nephritis in a Community Rheumatology Setting Authors: Nehad Soloman, Jawad Bilal, Romy Cabacungan, Scott Milligan, Andrew Sharobeem, John Tesser, Henry Leher About Lupus Nephritis Lupus nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes. About LUPKYNIS LUPKYNIS is a second generation calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of LUPKYNIS plus standard of care to preserve kidney health in patients with active LN without reliance on chronic high-dose glucocorticoids. It is the only clinical program to include three years of LN treatment and follow-up with mycophenolate mofetil (MMF) and steroids. About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (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 lead to serious, including fatal outcomes. Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly. Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly. 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. Monitor for neurologic symptoms. 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. Monitor serum potassium levels periodically. 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. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers. 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: Avoid use of LUPKYNIS. Lactation: Consider the mother’s clinical need for LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman. Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m 2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose. Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment. Please see Prescribing Information , including Boxed Warning, and Medication Guide for LUPKYNIS. Contacts Media & Investor Inquiries: Andrea Christopher Corporate Communications & Investor Relations Aurinia Pharmaceuticals Inc. achristopher@auriniapharma.com General Investor Inquiries: ir@auriniapharma.com

ROCKVILLE, Md. & EDMONTON, Alberta--( BUSINESS WIRE )--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the Japanese Ministry of Health, Labour, and Welfare has approved voclosporin, a second-generation calcineurin inhibitor, in combination with mycophenolate mofetil (MMF) to treat lupus nephritis (LN). The Company’s collaboration partner, Otsuka Pharmaceutical Co., Ltd., filed the new drug application (NDA) with Japanese regulatory authorities in November 2023. The approval is based on data from the AURORA Clinical Program, which included a 12-month, Phase 3, double-blind, randomized-controlled study, as well as a two-year extension study, assessing the efficacy and safety of voclosporin with MMF and low-dose glucocorticoids, compared to MMF and low-dose glucocorticoids alone, in LN patients. “ We are thrilled to achieve this milestone that will provide access to LUPKYNIS in Japan, where there is a high rate of lupus nephritis among Japanese lupus patients. Our successful strategic partnership with Otsuka has allowed us to bring LUPKYNIS to LN patients across Europe and now Japan, addressing a significant unmet need,” said Peter Greenleaf, President, and Chief Executive Officer of Aurinia. Aurinia and Otsuka entered a collaboration and licensing agreement in December 2020 for the development and commercialization of oral voclosporin in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of the agreement, Aurinia is eligible to receive a payment of $10 million U.S. dollars upon approval in Japan along with low double-digit royalties on net sales once launched. The Company will supply product to Otsuka to support the launch under the associated commercial supply agreement on a cost-plus basis. 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. About Lupus Nephritis Lupus nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes. About LUPKYNIS LUPKYNIS is a second generation calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of LUPKYNIS plus standard of care to preserve kidney health in patients with active LN without reliance on chronic high-dose glucocorticoids. It is the only clinical program to include three years of LN treatment and follow-up with mycophenolate mofetil (MMF) and steroids. About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (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 lead to serious, including fatal outcomes. Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. Monitor eGFR regularly. Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy. Monitor blood pressure regularly. 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. Monitor for neurologic symptoms. 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. Monitor serum potassium levels periodically. 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. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKYNIS with strong or moderate CYP3A4 inducers. 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: Avoid use of LUPKYNIS. Lactation: Consider the mother’s clinical need for LUPKYNIS and any potential adverse effects to the breastfed infant when prescribing LUPKYNIS to a lactating woman. Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose. Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment. Please see Prescribing Information , including Boxed Warning, and Medication Guide for LUPKYNIS.