Vir Grants Norgine Commercial Rights to Hepatitis Delta Therapy in Europe, Australia, and New Zealand

Vir Biotechnology has granted Norgine Pharma UK Limited exclusive commercial rights in Europe, Australia, and New Zealand for its investigational combination therapy tobevibart plus elebsiran for the treatment of chronic hepatitis delta (CHD). The agreement includes an upfront reimbursement payment of €55 million, up to €495 million in clinical, regulatory, and sales-based milestone payments, and tiered royalties ranging from the mid-teens to high-twenties percent on net sales.1

As part of the deal, Vir and Norgine will share ongoing clinical development costs for Vir’s ECLIPSE registrational program, with Norgine contributing approximately 25% of future external expenses. Vir said the cost-sharing arrangement is expected to extend its cash runway into the fourth quarter of 2027 under its current operating plan. Vir retains commercialization rights for tobevibart and elebsiran in the United States and all markets outside the licensed territory, excluding Greater China. Closing of the transaction in certain jurisdictions remains subject to regulatory approvals.¹

The licensing agreement builds on progress in Vir’s ECLIPSE clinical development program, which is evaluating the tobevibart–elebsiran combination for CHD. Vir confirmed that enrollment has been completed for ECLIPSE 3, a phase 2b head-to-head trial comparing the combination therapy with bulevirtide in bulevirtide-naïve patients. ECLIPSE 3 is designed to generate comparative data to support market access and reimbursement decisions, particularly in Europe and other international markets now covered under the Norgine agreement.¹

Clinical efficacy data supporting the program were reported last month from the phase 2 SOLSTICE trial, presented at The Liver Meeting of the American Association for the Study of Liver Diseases and simultaneously published in The New England Journal of Medicine. At 48 weeks, 66% (21 of 32) of participants receiving monthly doses of tobevibart plus elebsiran achieved hepatitis delta virus (HDV) RNA target not detected (TND). Responses were observed across subgroups, including participants with cirrhosis and high baseline HDV RNA levels. The regimen was well tolerated, with no grade 3 or higher treatment-related adverse events and no treatment-related discontinuations reported.¹

The combination therapy pairs tobevibart, an investigational broadly neutralizing monoclonal antibody targeting hepatitis B surface antigen (HBsAg) to block viral entry and reduce circulating viral particles, with elebsiran, an investigational small interfering RNA (siRNA) designed to degrade hepatitis B virus RNA transcripts and reduce HBsAg production. Both agents are administered subcutaneously. The combination has received Breakthrough Therapy and Fast Track designations from the FDA, as well as Priority Medicines (PRIME) and orphan drug designations from the European Medicines Agency.¹

CHD is considered the most severe form of chronic viral hepatitis and is associated with rapid progression to cirrhosis, liver failure, and liver-related mortality. There are no approved treatments for CHD in the United States, and therapeutic options remain limited globally.¹

In August 2025, Vir initiated the ECLIPSE registrational program with the launch of ECLIPSE 3, positioning the study to provide supportive comparative data alongside two phase 3 trials. ECLIPSE 1 evaluates the combination versus deferred treatment in regions with limited access to bulevirtide, while ECLIPSE 2 assesses switching to tobevibart and elebsiran in patients who have not achieved viral suppression on bulevirtide. Together, the three trials are designed to establish efficacy, safety, and clinical positioning across diverse treatment settings.²

More recently, Contagion spoke with Mark Eisner, MD, MPH, executive vice president and chief medical officer at Vir Biotechnology, following completion of enrollment in ECLIPSE 1. Eisner said the ECLIPSE program was structured to generate registrational evidence for both US and European submissions, with ECLIPSE 1 and ECLIPSE 2 forming the backbone of regulatory filings and ECLIPSE 3 providing critical head-to-head data versus bulevirtide. Primary completion for ECLIPSE 1 is expected in the fourth quarter of 2026, with topline results anticipated in the first quarter of 2027, while ECLIPSE 2 and ECLIPSE 3 continue to advance.³

References

1.Vir Biotechnology Grants Norgine Exclusive Commercial License to Chronic Hepatitis Delta Treatment Candidate in Europe, Australia & New Zealand, Including Global Cost Sharing Agreement for Ongoing ECLIPSE Clinical Development Program. December 16, 2025. Accessed December 19, 2025. https://investors.vir.bio/news/news-details/2025/Vir-Biotechnology-Grants-Norgine-Exclusive-Commercial-License-to-Chronic-Hepatitis-Delta-Treatment-Candidate-in-Europe-Australia--New-Zealand-Including-Global-Cost-Sharing-Agreement-for-Ongoing-ECLIPSE-Clinical-Development-Program/default.aspx

2.Vir Biotechnology successfully initiates all trials in ECLIPSE Registrational Program for chronic hepatitis delta. News release. Vir Biotechnology Inc. August 6, 2025. Accessed Dece,ber 19, 2025. https://www.businesswire.com/news/home/20250806509549/en/Vir-Biotechnology-Successfully-Initiates-all-Trials-in-ECLIPSE-Registrational-Program-for-Chronic-Hepatitis-Delta

3.Vir Biotechnology. Vir Biotechnology Announces Completion of Enrollment in ECLIPSE 1 Phase 3 Trial for Chronic Hepatitis Delta. November 3, 2025. Accessed November 10, 2025. https://investors.vir.bio/news/news-details/2025/Vir-Biotechnology-Announces-Completion-of-Enrollment-in-ECLIPSE-1-Phase-3-Trial-for-Chronic-Hepatitis-Delta/default.aspx