Aurinia Announces Japan Approval of LUPKYNIS® (Voclosporin) to Treat Lupus Nephritis
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced that the Japanese Ministry of Health, Labour, and Welfare has approved voclosporin in combination with mycophenolate mofetil (MMF) to treat lupus nephritis (LN). This approval is based on data from the AURORA Clinical Program, which included a 12-month Phase 3 study and a two-year extension study.
The company's collaboration partner, Otsuka Pharmaceutical Co., , filed the new drug application in November 2023. As part of their agreement, Aurinia is eligible to receive a $10 million payment upon approval in Japan, along with low double-digit royalties on net sales. Aurinia will supply the product to Otsuka on a cost-plus basis.
Voclosporin, marketed as LUPKYNIS in the U.S., was previously approved by the FDA in January 2021 for treating adult patients with active LN.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) ha annunciato che il Ministero della Salute, del Lavoro e del Welfare giapponese ha approvato voclosporin in combinazione con il mycophenolate mofetil (MMF) per trattare il lupus nefritico (LN). Questa approvazione si basa su dati del Programma Clinico AURORA, che ha incluso uno studio di Fase 3 di 12 mesi e uno studio di estensione di due anni.
Il partner di collaborazione dell'azienda, Otsuka Pharmaceutical Co., ha presentato la richiesta di nuovo medicinale nel novembre 2023. Nell'ambito del loro accordo, Aurinia ha diritto a ricevere un pagamento di 10 milioni di dollari all'approvazione in Giappone, insieme a royalties basse a doppia cifra sulle vendite nette. Aurinia fornirà il prodotto a Otsuka su una base di costo più margine.
Voclosporin, commercializzato come LUPKYNIS negli Stati Uniti, è stato precedentemente approvato dalla FDA nel gennaio 2021 per il trattamento di pazienti adulti con LN attivo.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) anunció que el Ministerio de Salud, Trabajo y Bienestar de Japón ha aprobado voclosporin en combinación con micofenolato mofetil (MMF) para tratar el lupus nefritico (LN). Esta aprobación se basa en datos del Programa Clínico AURORA, que incluyó un estudio de Fase 3 de 12 meses y un estudio de extensión de dos años.
El socio colaborador de la empresa, Otsuka Pharmaceutical Co., presentó la solicitud de nuevo fármaco en noviembre de 2023. Como parte de su acuerdo, Aurinia tiene derecho a recibir un pago de 10 millones de dólares al ser aprobada en Japón, junto con regalías menores de dos dígitos sobre las ventas netas. Aurinia suministrará el producto a Otsuka sobre una base de costo más margen.
Voclosporin, comercializado como LUPKYNIS en EE. UU., fue previamente aprobado por la FDA en enero de 2021 para el tratamiento de pacientes adultos con LN activo.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH)는 일본 후생 labor복지부가 보클로스포린을 마이코페놀레이트 모페틸(MMF)과 함께 루푸스 신염(LN) 치료를 위해 승인했다고 발표했습니다. 이 승인은 12개월 간의 3상 연구와 2년 연장 연구를 포함한 AURORA 임상 프로그램의 데이터에 기반하고 있습니다.
회사의 협력 파트너인 Otsuka Pharmaceutical Co.는 2023년 11월에 신약 신청서를 제출했습니다. 그들의 계약에 따라 Aurinia는 일본에서 승인이 날 경우 천만 달러의 지급을 받을 자격이 있으며, 순판매에 대한 낮은 두 자리 수의 로열티도 받을 수 있습니다. Aurinia는 Otsuka에 제품을 비용 가산 방식으로 공급할 것입니다.
미국에서 LUPKYNIS로 판매되는 보클로스포린은 2021년 1월에 FDA에 의해 활성 LN을 치료하기 위해 먼저 승인되었습니다.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) a annoncé que le ministère de la Santé, du Travail et du Bien-être japonais a approuvé le voclosporin en combinaison avec le mycophénolate mofétil (MMF) pour traiter le lupus néphritique (LN). Cette approbation est basée sur des données issues du Programme Clinique AURORA, qui comprenait une étude de Phase 3 de 12 mois et une étude d'extension de deux ans.
Le partenaire de collaboration de l'entreprise, Otsuka Pharmaceutical Co., a soumis la demande de nouveau médicament en novembre 2023. Dans le cadre de leur accord, Aurinia a droit à un paiement de 10 millions de dollars lors de l'approbation au Japon, ainsi qu'à des royalties faibles à deux chiffres sur les ventes nettes. Aurinia fournira le produit à Otsuka sur une base de coût majoré.
Le voclosporin, commercialisé sous le nom de LUPKYNIS aux États-Unis, avait été précédemment approuvé par la FDA en janvier 2021 pour le traitement de patients adultes atteints de LN actif.
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) hat bekannt gegeben, dass das japanische Ministerium für Gesundheit, Arbeit und Wohlfahrt Voclosporin in Kombination mit Mycophenolat-Mofetil (MMF) zur Behandlung von Lupusnephritis (LN) genehmigt hat. Diese Genehmigung basiert auf Daten aus dem AURORA-Klinikprogramm, das eine 12-monatige Phase-3-Studie und eine zweijährige Verlängerungsstudie umfasste.
Der Kooperationspartner des Unternehmens, Otsuka Pharmaceutical Co., hat im November 2023 den Antrag auf Zulassung eines neuen Medikaments eingereicht. Im Rahmen ihrer Vereinbarung hat Aurinia Anspruch auf eine Zahlung von 10 Millionen Dollar nach der Genehmigung in Japan sowie auf niedrige zweistellige Lizenzgebühren auf Nettoumsätze. Aurinia wird Otsuka das Produkt auf Kostenplusbasis liefern.
Voclosporin, das in den USA als LUPKYNIS vermarktet wird, wurde im Januar 2021 zuvor von der FDA zur Behandlung von erwachsenen Patienten mit aktiver LN genehmigt.
- Approval of voclosporin (LUPKYNIS) in Japan for lupus nephritis treatment
- Eligible to receive $10 million payment upon approval in Japan
- Low double-digit royalties on net sales in Japan
- Expansion of market reach through partnership with Otsuka Pharmaceutical
- None.
Insights
The approval of LUPKYNIS (voclosporin) in Japan marks a significant milestone for Aurinia Pharmaceuticals and patients with lupus nephritis (LN). This decision, based on robust clinical data from the AURORA program, addresses a critical unmet need in a country with a high prevalence of LN among lupus patients.
Key points to consider:
- Expanded market access: Japan's approval opens up a new, potentially lucrative market for Aurinia.
- Financial impact: The company will receive a
$10 million milestone payment and future low double-digit royalties on net sales. - Supply agreement: Aurinia will supply the product to Otsuka on a cost-plus basis, potentially providing a steady revenue stream.
- Global expansion: This approval follows the drug's launch in the U.S. and Europe, demonstrating Aurinia's successful global commercialization strategy.
For investors, this news signifies potential revenue growth and market expansion for Aurinia. The partnership with Otsuka also de-risks the commercialization process in Japan, leveraging local expertise. However, actual sales performance and market penetration will be critical to watch in the coming quarters to assess the true impact on Aurinia's financial health.
This regulatory approval in Japan is a positive development for Aurinia Pharmaceuticals, with several financial implications:
- Immediate revenue boost: The
$10 million milestone payment will positively impact the company's cash position. - Future revenue stream: Low double-digit royalties on net sales provide a potentially significant long-term income source, depending on market penetration and sales performance.
- Manufacturing revenue: The cost-plus supply agreement with Otsuka could contribute to steady cash flow and potentially improved margins.
- Market expansion: Japan represents a new market opportunity, diversifying Aurinia's revenue sources beyond the U.S. and Europe.
With a market cap of about
- Initial sales traction in Japan
- Impact on overall revenue growth
- Potential for increased analyst coverage and revised financial projections
While positive, the full financial impact will depend on successful commercialization and market adoption in Japan. The partnership with Otsuka mitigates some risks but also shares the potential upside.
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
Aurinia and Otsuka entered a collaboration and licensing agreement in December 2020 for the development and commercialization of oral voclosporin in the EU,
In January 2021, the
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
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
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 (≥
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.
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Media & Investor Inquiries:
Andrea Christopher
Corporate Communications & Investor Relations
Aurinia Pharmaceuticals Inc.
achristopher@auriniapharma.com
General Investor Inquiries:
ir@auriniapharma.com
Source: Aurinia Pharmaceuticals Inc.
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