Norgine enters exclusive licensing agreement with Vir Biotechnology
Esme Needham | December 18, 2025 | News story | Manufacturing and Production | Hepatology, Norgine, Vir Biotechnology
Norgine has announced its exclusive licensing agreement with Vir Biotechnology, under which Norgine will commercialise the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD) in Europe, Australia and New Zealand following marketing authorisations.
CHD is the most severe form of chronic viral hepatitis: the International Agency for Research on Cancer recently classified it as carcinogenic. Patients with CHD progress quickly to cirrhosis, liver failure and liver-related death. Options for treatment are limited in the EU and globally, and there are currently no approved treatments in the US.
Tobevibart is a monoclonal antibody targeting the hepatitis B surface antigen. It was identified using Vir’s proprietary monoclonal antibody discovery platform. Elebsiran is a hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals.
The combination of the two drugs was previously granted Breakthrough Therapy and Fast Track designations by the US Food and Drug Administration (FDA), as well as Priority Medicines (PRIME) and orphan drug designations by the European Medicines Agency (EMA), reflecting the urgent unmet medical need for new CHD treatments.
The terms of the licensing agreement state that Vir will receive reimbursement payments, regulatory and commercial milestone payments, and royalties on net sales. Norgine will be responsible for all commercialisation, and will hold marketing authorisations in its licensed territories.
Norgine is a European specialty pharmaceutical company, while Vir is a clinical-stage biopharmaceutical company focused on immunology.
“This collaboration strengthens our ability to deliver this important therapy to patients with CHD in need of efficacious, safe and convenient treatment options,” said Marianne De Backer, CEO of Vir.
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