Otsuka receives positive CHMP opinion for Lupkynis (voclosporin)for the treatment of active lupus nephritisTM

LONDON, UK, 22 July 2022 - Otsuka Pharmaceutical Europe Ltd. today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion relating to the use of Lupkynis (voclosporin) in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).TM Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), a chronic and debilitating autoimmune disease. Up to 210 in 100,000 people in Europe live with SLE and, while more prevalent in women, men who develop SLE may experience a more severe disease. Between 40 and 60 percent (depending on ancestry) of those with SLE are at risk of developing LN during their lifetime, which has been suggested to cause irreversible nephron loss.1,234,5,67,89 "Lupus nephritis can have severe consequences if inadequately managed, which is why the positive recommendation received today is a significant milestone as we continue to work towards being able to offer this treatment option to patients," said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd. "We look forward to the outcome of the European Commission (EC) decision which, if positive, would make voclosporin the first oral medicine approved in the EU to treat active LN in adult patients". The positive CHMP opinion is based on the results of the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study. The results of the AURORA 1 study demonstrated that voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone, with a generally comparable safety profile. The AURORA 2 study demonstrated long-term safety and tolerability of voclosporin with a generally similar safety profile and no unexpected safety signals compared to placebo (both taken in combination with MMF and low-dose oral steroids) in patients receiving treatment for an additional 24 months following their completion in the AURORA 1 study.10111213 The positive opinion from the CHMP will now be reviewed by the EC, which has the authority to approve medicines for EU member states, as well as Iceland, Norway, Liechtenstein, and Northern Ireland. The EC has 67 days from the CHMP opinion to issue a final decision. About Lupkynis (voclosporin)TM Voclosporin is an oral calcineurin inhibitor (CNI) for the treatment of LN secondary SLE. It has a postulated dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production, and promoting podocyte stability in the kidney.12 About the collaboration between Otsuka Pharmaceutical Co. Ltd and Aurinia In December 2020, Otsuka Pharmaceutical Co., Ltd. entered into a collaboration and licensing agreement with Aurinia for the development and commercialisation of voclosporin for the treatment of LN in the European Union, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. In February 2022, Swiss Medic granted Otsuka orphan drug status for voclosporin in LN. The US Food and Drug Administration approved voclosporin in combination with a background immunosuppressive therapy regimen, as the first FDA-approved oral medicine to treat adult patients with active LN in 2021. 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, focusing on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs in several under-addressed diseases including tuberculosis, a significant global public health issue. Otsuka Europe employs over 500 people and focuses on psychiatric and neurologic disorders, infectious disease, nephrology, oncology, and digital medicines. Otsuka Pharmaceutical Europe Ltd. is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide with consolidated sales of approximately €11.6 billion and a spend of €1.8 billion on research and development in 2021. 1 References Parodis I, Tamirou F and Houssiau FA. Treat-to-Target in Lupus Nephritis. What is the Role of the Repeat Kidney Biopsy? Archivum Immunologiae et Therapiae Experimentalis volume. 2022;70:8.1 Parodis I, Tamirou F, Houssiau FA. Prediction of prognosis and renal outcome in lupus nephritis. Lupus Science & Medicine. 2020;7:e000389. doi:10.1136/lupus-2020-000389.2 Barber MRW, Drenkard C, Falasinnu T, et al. Global epidemiology of systemic lupus erythematosus. Nat Rev Rheumatol. 2021;17:515-532.3 Goulielmos GN, Zervou MI, Vazgiourakis, VM, et al. The genetics and molecular pathogenesis of systemic lupus erythematosus (SLE) in populations of different ancestry. Gene. 2018;668:59-72. doi: 10.1016/j.gene.2018.05.0414 Bernatsky S, Boivin JF, Joseph L, et al Mortality in systemic lupus erythematosus. Arthritis Rheum. 2006 Aug;54(8):2550-7. doi: 10.1002/art.21955. PMID: 168689775 Ramírez Sepúlveda JI, Bolin K, Mofors J, et al. Sex differences in clinical presentation of systemic lupus erythematosus. Biol Sex Differ. 2019 Dec 16;10(1):60. doi: 10.1186/s13293-019-0274-2. PMID: 31843005; PMCID: PMC6915972.6 Barber MRW, Hanly JG, Su L, et al. Economic Evaluation of Lupus Nephritis in the Systemic Lupus International Collaborating Clinics Inception Cohort Using a Multistate Model Approach. Arthritis Care Res. 2018;70(9):1294-1302. doi: 10.1002/acr.23480.7 Hanly JG, O'Keeffe AG, Su L, et al. The frequency and outcome of lupus nephritis: results from an international inception cohort study. Rheumatology (Oxford). 2016;55(2):252-62. doi: 10.1093/rheumatology/kev311.8 Anders HJ, Saxena R, Zhao MH, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):7. doi:10.1038/s41572-019-0141-9.9 ClinicalTrials.gov. Aurinia Renal Response in Active Lupus With Voclosporin (AURORA). NCT03021499. Available from: https://clinicaltrials.gov/ct2/show/NCT03021499 [Last accessed: July 2022].10 ClinicalTrials.gov. Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2), NCT03597464. Available from: https://clinicaltrials.gov/ct2/show/NCT03597464 [Last accessed: July 2022].11 Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021;397:2070-2080.12 Saxena A, Mela C, Coeshall A. Voclosporin for Lupus Nephritis: Interim Analysis of the AURORA 2 Extension Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). Available from: https://acrabstracts.org/abstract/voclosporin-for-lupus-nephritis-interim-analysis-of-the-aurora-2-extension-study/. [Last accessed: July 2022].13

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