Norgine Secures Hepatitis Delta Therapy Rights Across Key Region

European specialty pharmaceutical company Norgine has entered an exclusive in-licensing agreement with US-based Vir Biotechnology to commercialize a combination therapy for chronic hepatitis delta (CHD), a severe and often rapidly progressive liver disease with limited treatment options, the company announced on Dec. 17, 2025 (1). The agreement covers Europe, Australia, and New Zealand, pending regulatory approvals, and reflects a broader industry trend toward regionally focused partnerships to advance late-stage specialty therapies (1,2).

The licensed regimen combines tobevibart, an investigational monoclonal antibody (mAb), with elebsiran, an investigational small interfering RNA therapeutic. Together, these agents are designed to disrupt the hepatitis delta virus life cycle through complementary mechanisms, an approach that may help address persistent unmet medical need in hepatology.

“Norgine has a rich history in hepatology and specialty care, and this transaction represents a highly innovative and synergistic portfolio addition to continue our strong foothold in this space,” said Janneke van der Kamp, CEO, Norgine, in a company press release (1). “By combining our proven commercial and regional expertise with cutting-edge science from Vir Biotechnology, we are reinforcing our commitment to improving healthcare outcomes.”

Why does chronic hepatitis delta remain a high-priority unmet need?

CHD is widely regarded as the most severe form of chronic viral hepatitis and is associated with accelerated progression to cirrhosis, liver failure, and liver-related mortality. The disease depends on hepatitis B virus surface antigen for replication, complicating therapeutic strategies and limiting the effectiveness of existing options (3). Regulatory agencies and public health organizations have increasingly emphasized the need for new approaches as current treatments remain scarce, particularly in the United States and parts of Europe (4).

The combination of tobevibart and elebsiran is designed to target both viral entry and antigen production. Tobevibart is engineered to neutralize hepatitis B surface antigen and inhibit viral entry into hepatocytes, while elebsiran reduces production of the same antigen by degrading viral RNA transcripts in the liver. The dual-mechanism strategy reflects a growing focus in antiviral development on combination regimens that can produce deeper and more durable virological responses (1).

How does this licensing deal reshape development and commercialization strategy?

Under the agreement, Vir Biotechnology will receive an initial reimbursement payment of €55 million (US$65 million) with up to €495 million (US$582 million) in additional regulatory and commercial milestones, along with tiered royalties on net sales. Development costs for ongoing registrational studies in a clinical program (ECLIPSE) will be shared, with Norgine contributing to future external costs.

Such arrangements highlight how companies with established regional infrastructure can play a central role in advancing late-stage assets developed by innovation-focused biotechs (2). By assuming responsibility for commercialization and marketing authorizations in its territories, Norgine provides a pathway for accelerating patient access without duplicating commercial capabilities across geographies (1).

What are the broader implications for biopharma R&D and manufacturing?

Both tobevibart and elebsiran are administered subcutaneously and are in advanced clinical development, factors that may influence manufacturing, supply chain planning, and future scale-up strategies if approved. The involvement of mAb engineering, RNA interference technology, and combination dosing underscores the increasing technical complexity of modern antiviral therapies (1).

The combination regimen has received multiple expedited regulatory designations, including breakthrough therapy and fast track status in the United States and priority medicines and orphan drug designations in Europe, signaling strong regulatory interest in advancing new options for this indication.

“This collaboration strengthens our ability to deliver this important therapy to patients with chronic hepatitis delta in need of efficacious, safe, and convenient treatment options,” said Marianne De Backer, PhD, CEO, Vir Biotechnology, in the release (1). “Together, we aim to broaden access and improve outcomes for people living with this severe disease.”

If successful, the partnership could serve as a model for how targeted licensing agreements enable specialized therapies to reach markets efficiently while aligning scientific innovation with regional commercialization expertise (5).

References

1. Norgine. Norgine Enhances Hepatology and Specialty Portfolio Through Exclusive In-Licensing Agreement with Vir Biotechnology. Press Release. Dec. 17, 2025.
2. Ernst & Young. EY 2025 Biotech Beyond Borders Report: Biopharma—Focus on Fundamentals to Bounce Back. Press Release. June 18, 2025.
3. Lampertico, P.; Degasperi, E.; Sandmann, L.; et al. Hepatitis D Virus Infection: Pathophysiology, Epidemiology and Treatment. Report From the First International Delta Cure Meeting 2022. JHEP Rep. 2023, 5 (9), 100818. DOI: 10.1016/j.jhepr.2023.100818
4. Park, J.; Sayed, A.; Nasir, S. A.; Lim, J. K. Advances in Treatment of Hepatitis Delta Virus Infection: Update on Novel Investigational Drugs. World J Virol. 2025, 14 (2),102673. DOI: 10.5501/wjv.v14.i2.102673
5. von Minden, M.; Gonzalez, R. Why Licensing Deals are a Powerful Source of Growth in Life Sciences. EY.com. Oct. 3, 2024.