Full Press Release Details
Alumis and Kaken Pharmaceutical Announce Collaboration
and Licensing Agreement for ESK-001 in Dermatology in Japan
- Alumis to receive $40 million in upfront
and near-term co-development payments, with potential for approximately $140 million in additional milestone and field option payments,
plus tiered royalties on future sales
-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
SAN FRANCISCO, Calif. & Bunkyo-ku, TOKYO, March 25, 2025 - 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 $40 million in upfront and near-term co-development payments in 2025 to 2026, with the potential to earn up to approximately $140
million in additional payments based on the achievement of milestones, and field option payments. Alumis is also eligible to receive tiered
royalties ranging from the low double-digits into the twenties on aggregate net sales of ESK-001 in Japan. Kaken will be responsible
for the clinical development, regulatory approvals and commercialization of ESK-001 in Japan, and Alumis will retain rights to ESK-001
in all other geographies. Kaken will also contribute to a portion of the global development costs of ESK-001.
"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."
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."
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.
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
Red House Communications
Kaken Contact Information
Corporate Communications Department