Esperion Partner Otsuka Receives Regulatory Approval to Market NEXLETOL® in Japan for the Treatment of Hypercholesterolemia
Esperion (NASDAQ: ESPR) announced that its partner Otsuka Pharmaceutical has received approval from Japanese regulators to market NEXLETOL for treating hypercholesterolemia and familial hypercholesterolemia in Japan. This approval marks NEXLETOL's entry into the third-largest global market for cardiovascular prevention.
The approval triggers milestone payments to Esperion under their partnership agreement with Otsuka, which includes tiered royalties of 15-30% on net sales in Japan and additional sales milestone payments. NEXLETOL, a non-statin LDL-C lowering therapy, is now approved across the U.S., Europe, and Japan, establishing a strong global presence for Esperion's cholesterol treatment.
Esperion (NASDAQ: ESPR) ha annunciato che il suo partner Otsuka Pharmaceutical ha ottenuto l'approvazione dai regolatori giapponesi per commercializzare NEXLETOL per trattare l'ipercolesterolemia e l'ipercolesterolemia familiare in Giappone. Questa approvazione segna l'ingresso di NEXLETOL nel terzo mercato globale per la prevenzione cardiovascolare.
L'approvazione genera pagamenti di milestone a Esperion secondo l'accordo di partenariato con Otsuka, che comprende royalty a scaglioni dal 15% al 30% sulle vendite nette in Giappone e ulteriori pagamenti legati ai traguardi di vendita. NEXLETOL, una terapia non statina per abbassare LDL-C, è ora approvata negli Stati Uniti, in Europa e in Giappone, consolidando una forte presenza globale nel trattamento dell'ipercolesterolemia di Esperion.
Esperion (NASDAQ: ESPR) anunció que su socio Otsuka Pharmaceutical ha recibido la aprobación de los reguladores japoneses para comercializar NEXLETOL para tratar la hipercolesterolemia y la hipercolesterolemia familiar en Japón. Esta aprobación marca la entrada de NEXLETOL en el tercer mercado global de prevención cardiovascular.
La aprobación activa pagos por hitos a Esperion bajo su acuerdo de asociación con Otsuka, que incluye royalties escalonados del 15-30% de las ventas netas en Japón y pagos de hitos de ventas adicionales. NEXLETOL, una terapia para reducir LDL-C no basada en estatinas, ya está aprobada en EE. UU., Europa y Japón, estableciendo una fuerte presencia global para el tratamiento de la colesterol de Esperion.
Esperion (NASDAQ: ESPR)은 파트너인 Otsuka Pharmaceutical가 일본 규제 당국으로부터 NEXLETOL을 일본에서 고지혈증과 가족성 고지혈증 치료제로 판매하는 승인을 받았다고 발표했습니다. 이번 승인은 심혈관 예방을 위한 글로벌 3번째 대형 시장으로의 NEXLETOL 진입을 의미합니다.
이 승인은 Otsuka와의 파트너십 계약에 따라 Esperion에 마일스톤 지급을 촉발하며, 일본에서 순매출에 대한 누적 로열티 15-30%와 추가 매출 마일스톤 지급이 포함됩니다. 비스타틴계 LDL-C 저하 치료제인 NEXLETOL은 미국, 유럽 및 일본에서 승인되어 Esperion의 글로벌 콜레스테롤 치료제 입지를 강화합니다.
Esperion (NASDAQ: ESPR) a annoncé que son partenaire Otsuka Pharmaceutical a obtenu l'approbation des régulateurs japonais pour commercialiser NEXLETOL afin de traiter l'hypercholestérolémie et l'hypercholestérolémie familiale au Japon. Cette approbation marque l'entrée de NEXLETOL sur le troisième marché mondial de la prévention cardiovasculaire.
L'approbation déclenche des paiements d'étapes à Esperion dans le cadre de leur accord de partenariat avec Otsuka, qui prévoit des redevances échelonnées de 15 à 30% sur les ventes nettes au Japon et des paiements supplémentaires liés à des jalons de vente. NEXLETOL, une thérapie non statine de réduction du LDL-C, est désormais approuvée aux États-Unis, en Europe et au Japon, consolidant une forte présence mondiale pour le traitement de l'hypercholestérolémie par Esperion.
Esperion (NASDAQ: ESPR) kündigte an, dass sein Partner Otsuka Pharmaceutical von den japanischen Regulierungsbehörden die Zulassung zur Vermarktung von NEXLETOL zur Behandlung von Hypercholesterinämie und familiärer Hypercholesterinämie in Japan erhalten hat. Diese Zulassung markiert den Einstieg von NEXLETOL in den drittgrößten globalen Markt für kardiovaskuläre Prävention.
Die Zulassung löst Meilensteinzahlungen an Esperion gemäß ihrer Partnerschaft mit Otsuka aus, die gleitende Lizenzgebühren von 15-30 % des Nettoumsatzes in Japan sowie zusätzliche Vertrieb-Milestones vorsieht. NEXLETOL, eine LDL-C-senkende Therapie ohne Statine, ist nun in den USA, Europa und Japan genehmigt und stärkt die globale Präsenz von Esperions Cholesterinbehandlung.
Esperion (NASDAQ: ESPR) أعلنت أن شريكها Otsuka Pharmaceutical حصل على موافقة الجهات التنظيمية اليابانية لتسويق NEXLETOL لعلاج فرط كوليسترول الدم وفرط كوليسترول الدم العائلي في اليابان. تمثل هذه الموافقة دخول NEXLETOL إلى ثالث أكبر سوق عالمي للوقاية القلبية الوعائية.
تفعّل هذه الموافقة دفعات موجّهة إلى Esperion بموجب اتفاقية شراكة مع Otsuka، والتي تتضمن حقوق ملكية متدرجة من 15-30% من صافي المبيعات في اليابان ودفع مبالغ إضافية عند تحقيق مراحل مبيعات. NEXLETOL، وهو علاج لخفض LDL-C ليس من محفزات الستاتين، مُزَمن الآن مع الموافقات في الولايات المتحدة وأوروبا واليابان، مما يعزز حضور Esperion العالمي في علاج الكولسترول.
Esperion (NASDAQ: ESPR) 宣布其合作伙伴 Otsuka Pharmaceutical 已获得日本监管机构批准，在日本上市销售用于治疗高胆固醇血症和家族性高胆固醇血症的 NEXLETOL。这一批准标志着 NEXLETOL 进入全球第三大心血管预防市场。
该批准将根据与 Otsuka 的伙伴关系协议触发对 Esperion 的里程碑支付，其中包括在日本的 净销售额的分级特许权使用费 15-30% 以及额外的销售里程碑支付。NEXLETOL 作为非他汀类 LDL-C 降低治疗药物，现已在美国、欧洲和日本获批，进一步巩固了 Esperion 在全球范围内的胆固醇治疗市场地位。
- Regulatory approval secured in Japan, one of the top 3 global markets for cardiovascular prevention
- Eligible for significant milestone payments upon regulatory approval and National Health Insurance Price Listing
- Will receive tiered royalties of 15-30% on net sales in Japan
- Expanded global footprint with approvals now in US, Europe, and Japan
- None.
Third Largest Global Market for Cardiovascular Prevention Represents Significant Global Growth Opportunity for NEXLETOL
ANN ARBOR, Mich., Sept. 19, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka), the Company’s partner for the development and commercialization of NEXLETOL® (bempedoic acid) tablets in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare to market NEXLETOL as a treatment for hypercholesterolemia and familial hypercholesterolemia.
“Securing regulatory approval in Japan – one of the top three global markets for cardiovascular prevention – represents a major step forward in our international growth strategy. With NEXLETOL now approved across the U.S., Europe, and Japan, we’ve established a strong global footprint and expanded access to a differentiated, non-statin LDL-C lowering therapy for patients who need alternatives,” said Sheldon Koenig, President and CEO of Esperion. “Our partnership with Otsuka positions us to unlock significant value in Japan, and we remain focused on driving long-term growth and shareholder value through continued innovation and market expansion.”
Under the terms of the collaboration and license agreement, Esperion is eligible to receive significant milestone payments upon regulatory approval and National Health Insurance Price Listing for NEXLETOL in the Otsuka territory. In addition, Esperion is eligible to receive additional sales milestone payments based on total net sales achievements by Otsuka in Japan, as well as tiered royalties ranging from fifteen percent to thirty percent on net sales in Japan.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.
Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com and follow Esperion on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway and profitability, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Esperion Contact Information:
Investors:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
FAQ
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