MedPath

Viatris Acquires Global Rights to Cenerimod for Autoimmune Diseases with $10M Nxera Deal

• Viatris has secured exclusive global rights to cenerimod, a novel oral S1P1 receptor modulator, through a $10 million upfront payment to Nxera Pharma for Japan and APAC territories.

• Cenerimod is currently advancing in Phase 3 trials as a potential first-in-class oral therapy for systemic lupus erythematosus, showing promise across multiple autoimmune disorders.

• The agreement includes milestone payments upon Japanese regulatory approval and royalties on net sales, strengthening Viatris's position in the immunology therapeutic space.

Viatris Inc. has consolidated global rights to cenerimod, a promising autoimmune disease therapy, through a strategic agreement with Nxera Pharma for Japan and Asia-Pacific territories (excluding China). The deal, announced on February 28, 2025, involves a US$10 million upfront payment to Nxera, with additional milestone payments tied to regulatory approval in Japan.

Strategic Expansion of Immunology Portfolio

The agreement marks a significant expansion of Viatris's immunology platform, building upon their previous acquisition of cenerimod rights in other territories from Idorsia in February 2024. This latest deal establishes Viatris as the exclusive global rights holder for the candidate, strengthening their position in the autoimmune disease market.

Innovative Therapeutic Approach

Cenerimod represents a novel approach to treating autoimmune conditions, functioning as a highly selective, oral sphingosine-1-phosphate receptor 1 (S1P1) modulator. The drug candidate, originally discovered by Idorsia, is currently undergoing Phase 3 clinical trials for systemic lupus erythematosus (SLE), where it shows potential as a first-in-class oral therapy.

Development and Commercial Implications

Dr. Makoto Sugita, EVP, CMO and President of Nxera Pharma Japan, emphasized the drug's potential: "Cenerimod has demonstrated compelling disease-modifying activity across multiple autoimmune disorders and already has become a key development asset for Viatris within its immunology platform."
The agreement structure includes provisions for Nxera to receive royalties on net sales in the assigned territories, should the drug achieve commercialization. This arrangement aligns with both companies' strategic objectives - providing Viatris with complete control over global development while ensuring Nxera maintains financial interest in the drug's success.

Market Position and Future Outlook

The consolidation of global rights under Viatris's control streamlines the development pathway for cenerimod, potentially accelerating its progress through clinical trials and regulatory approvals. This unified approach to development and commercialization could prove crucial in bringing this innovative therapy to patients with autoimmune conditions worldwide.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Nxera Pharma Partners with Holling Bio-Pharma to Launch Daridorexant for Insomnia in Taiwan

Nxera Pharma has established a strategic partnership with Holling Bio-Pharma, Taiwan's largest pharmaceutical distributor, to commercialize daridorexant for insomnia treatment in the Taiwanese market.
The agreement addresses a significant medical need in Taiwan, where sleep disorders affect 12-20% of the adult population, approximately 4-5 million people as of 2021.

Neurocrine Biosciences Gains Exclusive Rights to Osavampator for Depression Treatment Outside Japan

Neurocrine Biosciences amended its agreement with Takeda to obtain exclusive worldwide rights to develop and commercialize osavampator for major depressive disorder (MDD), excluding Japan.
Osavampator (NBI-1065845) demonstrated statistically significant improvements in depression symptoms in a Phase 2 trial, meeting primary and key secondary endpoints.

Dimerix Licenses Phase 3 FSGS Drug DMX-200 to FUSO Pharma for ¥10.5 Billion

Dimerix has granted FUSO Pharmaceutical Industries exclusive rights to develop and commercialize DMX-200 in Japan for focal segmental glomerulosclerosis (FSGS).
The agreement includes an upfront payment of ¥300 million to Dimerix, with potential milestone payments reaching up to ¥9.8 billion, plus royalties.

VYVDURA Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy

Japan's MHLW has approved VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) for treating adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
VYVDURA is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP treatment, administered as a weekly subcutaneous injection.

Newron Pharmaceuticals Expands Evenamide Reach in Asia with New Licensing Agreements

Newron Pharmaceuticals has partnered with Myung In Pharm for the development and commercialization of evenamide in South Korea, contributing to a Phase III trial.
EA Pharma, a subsidiary of Eisai, has secured a license agreement with Newron for evenamide in Japan and other Asian territories, providing significant upfront payment.

Nxera Pharma Initiates Phase 3 Trial of Daridorexant for Insomnia in South Korea

Nxera Pharma has enrolled the first patient in a Phase 3 clinical trial in South Korea to evaluate daridorexant for treating insomnia.
The trial aims to secure marketing authorization from South Korea's Ministry of Food and Drug Safety, with results expected in 1H 2026.

Atsena Therapeutics and Nippon Shinyaku Partner to Advance Gene Therapy for LCA1

Atsena Therapeutics and Nippon Shinyaku have entered an exclusive license agreement to commercialize ATSN-101 in the U.S. and Japan, a gene therapy for Leber congenital amaurosis (LCA1).
Nippon Shinyaku will have exclusive commercial rights in the U.S. and Japan, with Atsena retaining rights in other regions, and NS Pharma Inc. will market ATSN-101 in the U.S.

Nxera Pharma Partners with Shionogi for Quviviq Distribution in Japan Following Approval for Insomnia

Nxera Pharma has entered a commercial partnership with Shionogi for the distribution and sales of Quviviq in Japan, succeeding a prior agreement with Mochida Pharmaceutical.
Quviviq, a dual orexin receptor antagonist, received approval in Japan for treating adult insomnia, marking a significant advancement in addressing sleep disorders.

Lupkynis (Voclosporin) Approved in Japan for Lupus Nephritis Treatment

The Japanese Ministry of Health, Labour, and Welfare approved Lupkynis (voclosporin) in combination with mycophenolate mofetil for treating lupus nephritis.
This approval was based on the AURORA Clinical Program, which demonstrated Lupkynis' efficacy and safety in treating lupus nephritis patients.

Nicox's ZERVIATE Approved in China for Allergic Conjunctivitis

Ocumension Therapeutics, Nicox's partner, has received approval in China to commercialize ZERVIATE for treating ocular itching linked to allergic conjunctivitis.
The approval of ZERVIATE marks the first cetirizine ophthalmic solution available in China, addressing a significant gap in treatment options for allergic conjunctivitis.

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy