Alumis and Kaken Pharmaceutical Announce Collaboration and Licensing Agreement for ESK-001 in Dermatology in Japan
Alumis (NASDAQ: ALMS) and Kaken Pharmaceutical have announced a collaboration and licensing agreement for ESK-001, a next-generation oral TYK2 inhibitor, in Japan. The deal includes $40 million in upfront and near-term co-development payments during 2025-2026, with potential for additional $140 million in milestone and field option payments, plus tiered royalties ranging from low double-digits to twenties on net sales.
Kaken will handle clinical development, regulatory approvals, and commercialization of ESK-001 in Japan for dermatology indications, with an option to expand into rheumatological and gastrointestinal diseases. The company will also contribute to global development costs, while Alumis retains rights in all other regions. The partnership builds on ESK-001's positive Phase 2 clinical data.
Alumis (NASDAQ: ALMS) e Kaken Pharmaceutical hanno annunciato una collaborazione e un accordo di licenza per ESK-001, un inibitore orale di nuova generazione di TYK2, in Giappone. L'accordo include 40 milioni di dollari in pagamenti iniziali e di co-sviluppo a breve termine durante il 2025-2026, con potenziale per ulteriori 140 milioni di dollari in pagamenti legati a traguardi e opzioni di campo, oltre a royalties scaglionate che vanno da cifre basse a doppie a venti sulle vendite nette.
Kaken si occuperà dello sviluppo clinico, delle approvazioni regolatorie e della commercializzazione di ESK-001 in Giappone per indicazioni dermatologiche, con un'opzione di espansione nelle malattie reumatologiche e gastrointestinali. L'azienda contribuirà anche ai costi di sviluppo globale, mentre Alumis mantiene i diritti in tutte le altre regioni. La partnership si basa sui positivi dati clinici della Fase 2 di ESK-001.
Alumis (NASDAQ: ALMS) y Kaken Pharmaceutical han anunciado una colaboración y un acuerdo de licencia para ESK-001, un inhibidor oral de TYK2 de nueva generación, en Japón. El acuerdo incluye 40 millones de dólares en pagos iniciales y de co-desarrollo durante 2025-2026, con potencial para 140 millones de dólares adicionales en pagos por hitos y opciones de campo, además de regalías escalonadas que van desde cifras bajas de dos dígitos hasta veinte sobre las ventas netas.
Kaken se encargará del desarrollo clínico, las aprobaciones regulatorias y la comercialización de ESK-001 en Japón para indicaciones dermatológicas, con una opción de expansión a enfermedades reumatológicas y gastrointestinales. La empresa también contribuirá a los costos de desarrollo global, mientras que Alumis retiene derechos en todas las demás regiones. La asociación se basa en los positivos datos clínicos de la Fase 2 de ESK-001.
Alumis (NASDAQ: ALMS)와 Kaken Pharmaceutical은 일본에서 차세대 경구용 TYK2 억제제 ESK-001에 대한 협력 및 라이선스 계약을 발표했습니다. 이 계약에는 2025-2026년 동안의 선불 및 단기 공동 개발 비용으로 4천만 달러가 포함됩니다, 추가로 1억 4천만 달러의 이정표 및 현장 옵션 지급 가능성, 그리고 순매출에 대해 낮은 두 자릿수에서 20대에 이르는 단계별 로열티가 포함됩니다.
Kaken은 일본에서 피부과 적응증을 위한 ESK-001의 임상 개발, 규제 승인 및 상용화를 담당하며, 류마티스 및 위장 질환으로의 확장 옵션을 갖습니다. 이 회사는 또한 글로벌 개발 비용에 기여할 것이며, Alumis는 다른 모든 지역에 대한 권리를 유지합니다. 이 파트너십은 ESK-001의 긍정적인 2상 임상 데이터를 기반으로 합니다.
Alumis (NASDAQ: ALMS) et Kaken Pharmaceutical ont annoncé un accord de collaboration et de licence pour ESK-001, un inhibiteur oral de TYK2 de nouvelle génération, au Japon. Le contrat comprend 40 millions de dollars en paiements initiaux et de co-développement à court terme durant 2025-2026, avec un potentiel de 140 millions de dollars supplémentaires en paiements liés à des jalons et des options de terrain, ainsi que des redevances échelonnées allant de faibles chiffres à deux chiffres jusqu'à vingt sur les ventes nettes.
Kaken s'occupera du développement clinique, des approbations réglementaires et de la commercialisation d'ESK-001 au Japon pour des indications dermatologiques, avec une option d'expansion dans les maladies rhumatologiques et gastro-intestinales. L'entreprise contribuera également aux coûts de développement mondial, tandis qu'Alumis conserve des droits dans toutes les autres régions. Le partenariat s'appuie sur les données cliniques positives de la phase 2 d'ESK-001.
Alumis (NASDAQ: ALMS) und Kaken Pharmaceutical haben eine Zusammenarbeit und Lizenzvereinbarung für ESK-001, einen neuartigen oralen TYK2-Inhibitor, in Japan bekannt gegeben. Die Vereinbarung umfasst 40 Millionen Dollar an Vorauszahlungen und kurzfristigen Co-Entwicklungszahlungen für die Jahre 2025-2026, mit der Möglichkeit zusätzlicher 140 Millionen Dollar an Meilenstein- und Feldoptionszahlungen, sowie gestaffelte Lizenzgebühren, die von niedrigen zweistelligen Beträgen bis zu zwanzig Prozent auf den Nettoumsatz reichen.
Kaken wird die klinische Entwicklung, die regulatorischen Genehmigungen und die Vermarktung von ESK-001 in Japan für dermatologische Indikationen übernehmen, mit der Option, in rheumatologische und gastrointestinale Erkrankungen zu expandieren. Das Unternehmen wird auch zu den globalen Entwicklungskosten beitragen, während Alumis die Rechte in allen anderen Regionen behält. Die Partnerschaft basiert auf den positiven klinischen Daten der Phase 2 von ESK-001.
- Secured $40M in upfront and near-term payments for 2025-2026
- Additional $140M potential in milestone and option payments
- Tiered royalties from low double-digits to twenties on Japan sales
- Positive Phase 2 clinical data for ESK-001
- Partnership with established dermatology leader in Japan
- Retained rights to ESK-001 in all other geographies
- Kaken to contribute to global development costs
- to Japanese market only
- Development and commercialization dependent on third party in Japan
Insights
This licensing deal represents a significant financial win for Alumis, bringing in
The agreement's structure is particularly advantageous for a clinical-stage company like Alumis. By offloading regional development costs while securing Kaken's contribution to global development expenses, Alumis effectively extends its cash runway while maintaining full rights to ESK-001 in all markets outside Japan. This capital-efficient approach allows them to advance their pipeline while mitigating financial risk.
Most impressive is the royalty structure, which reaches into the twenties at the high end - exceptionally strong terms that reflect confidence in the commercial potential of ESK-001. The option for Kaken to expand into additional indications creates further upside potential beyond the initial dermatology focus. For investors, this partnership validates both Alumis's technology and business strategy, potentially reducing the company's risk profile while maintaining significant upside.
This collaboration with Kaken represents a strategic masterstroke for Alumis, leveraging complementary strengths to maximize ESK-001's market potential. Kaken's established position in Japanese dermatology provides immediate credibility and commercialization infrastructure that would take years for Alumis to build independently.
The deal structure reflects growing industry recognition of TYK2 inhibitors as a promising therapeutic class. Unlike first-generation JAK inhibitors with broader immunosuppressive effects, selective TYK2 inhibitors like ESK-001 target specific inflammatory pathways with potentially improved safety profiles. The reference to positive Phase 2 data suggests clinical validation that attracted Kaken's interest.
Particularly noteworthy is the option for expansion into rheumatological and gastrointestinal indications, signaling confidence in ESK-001's potential beyond dermatology. This multi-indication strategy aligns with industry best practices for maximizing return on R&D investment. By securing Japanese commercialization through partnership while retaining global rights, Alumis preserves flexibility for future deals in larger markets like the US and EU, potentially at higher valuations following additional clinical validation.
- Alumis to receive
-Deal underscores the commercial potential of Alumis’ ESK-001 and leverages Kaken’s regional capabilities and expertise in novel dermatology treatments
-Kaken has the option to license ESK-001 for further clinical development and commercialization in rheumatological and gastrointestinal diseases
SOUTH SAN FRANCISCO, Calif. and BUNKYO-KU, Tokyo, March 25, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, and Kaken Pharmaceutical Co., Ltd. (Tokyo Stock Exchange: 4521) today announced that the companies have entered into a collaboration and licensing agreement to develop, manufacture and commercialize ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, for dermatology indications in Japan, with the option to expand the license to include rheumatological and gastrointestinal diseases.
Under the terms of the agreement, Alumis will receive
“We are thrilled to announce this agreement with Kaken, a dermatology leader with significant reach and expertise in the Japanese market,” said Martin Babler, President and Chief Executive Officer of Alumis. “This partnership builds on the positive Phase 2 clinical data of ESK-001, our next-generation oral TYK2 inhibitor, supporting our objectives to unlock its full therapeutic potential and ensure ESK-001 is widely accessible to people with immune-mediated disorders around the world.”
“We are delighted to enter into an agreement with Alumis to develop ESK-001 for the Japanese market,” said Hiroyuki Horiuchi, President and Representative Director of Kaken. “We strongly believe in the potential of ESK-001 to address a range of medical needs in the dermatology space and potentially rheumatological and gastrointestinal diseases in the future. ESK-001 will be an important addition to the Kaken portfolio of novel therapeutics for dermatology conditions.”
About ESK-001
Alumis' lead clinical candidate, ESK-001, is a highly selective, next-generation oral TYK2 inhibitor that is designed to correct immune dysregulation across a spectrum of diseases driven by proinflammatory mediators, including IL-23, IL-17, and type 1 interferon (IFN). ESK-001's selective targeting is designed to deliver maximal inhibition while minimizing off-target binding and effects.
ESK-001 is currently being evaluated in the Phase 3 ONWARD clinical program, which consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, including trial sites in Japan, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis. Patients completing Week 24 will have the opportunity to participate in a long-term extension (LTE) trial, ONWARD3, that will evaluate durability and maintenance of response and long-term safety. The Phase 3 clinical program is supported by positive data from the Phase 2 STRIDE clinical trial and the ongoing long-term OLE extension showing that ESK-001 treatment led to robust long-term clinical responses and was well tolerated through 52 weeks. In parallel with the Phase 3 clinical program, Alumis is developing a once-daily modified release oral formulation of ESK-001 designed to replace the current immediate release oral formulation that is dosed twice daily.
ESK-001 is also being evaluated in LUMUS, a Phase 2b clinical trial for the treatment of patients with systemic lupus erythematosus. In addition, Alumis continues to leverage its precision data analytics platform to explore ESK-001’s potential application in other immune-mediated conditions.
About Alumis
Alumis is a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases. Leveraging its proprietary precision data analytics platform, Alumis is building a pipeline of molecules with the potential to address a broad range of immune-mediated diseases as monotherapy or combination therapies. Alumis’ most advanced product candidate, ESK-001, is an oral, highly selective, small molecule, allosteric inhibitor of TYK2 that is currently being evaluated for the treatment of patients with moderate-to-severe plaque psoriasis and systemic lupus erythematosus. Alumis is also developing A-005, a clinical-stage, CNS-penetrant, allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases. Beyond TYK2, Alumis’ proprietary precision data analytics platform and drug discovery expertise have led to the identification of additional preclinical programs that exemplify its precision approach. Incubated by Foresite Labs and led by a team of industry veterans experienced in small-molecule compound drug development for immune-mediated diseases, Alumis is pioneering a precision approach to drug development to potentially produce the next generation of treatment to address immune dysfunction.
For more information, visit www.alumis.com.
About Kaken Pharmaceutical
Kaken Pharmaceutical is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals in the fields of orthopedics and dermatology. Kaken concentrates its R&D resources in areas such as immune system, nervous system, infectious diseases and rare diseases with unmet medical needs. Kaken, in its philosophy, strives to improve the quality of life of patients through the development and distribution of superior pharmaceuticals.
For further information, visit www.kaken.co.jp/english.
Forward-Looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding Alumis’ future plans and prospects including development and commercialization of its pipeline, the potential for ESK-001 to be a best-in-class oral treatment for moderate-to-severe plaque psoriasis, any expectations regarding the safety, efficacy or tolerability of ESK-001 and the potential of ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus and the collaboration with Kaken and the intended and potential benefits thereof, including the receipt of potential co-development, milestone and royalty payments. Any forward-looking statements in this press release are based on Alumis’ current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis’ ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to fund development activities and achieve development goals, Alumis’ ability to protect its intellectual property and other risks and uncertainties described in Alumis’ filings with the Securities and Exchange Commission (SEC), including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Alumis Contact Information Teri Dahlman Red House Communications teri@redhousecomms.com Kaken Contact Information Corporate Communications Department Contact https://www.kaken.co.jp/english/contact/
FAQ
What is the total value of the Alumis (ALMS) and Kaken Pharmaceutical licensing deal for ESK-001?
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