Vir Biotechnology, Inc. has granted Norgine Pharma UK Limited an exclusive commercial license for its combination therapy of tobevibart and elebsiran for chronic hepatitis delta (CHD) in Europe, Australia, and New Zealand.
Under the agreement, Vir will receive an initial reimbursement payment of EUR 55 million and may earn up to EUR 495 million in clinical, regulatory, and sales milestones, along with tiered mid-teen to high-twenties percent royalties on net sales.
Vir retains commercialization rights in the United States and markets outside Greater China. Clinical development costs for the ongoing ECLIPSE registrational program, including ECLIPSE 1, 2, and 3 trials, will be shared, with Norgine contributing approximately 25 percent of future external costs. Enrollment for ECLIPSE 3, a Phase 2b head-to-head trial against bulevirtide, has been completed to support access and reimbursement in Europe and other key markets.
Data from the Phase 2 SOLSTICE trial showed that 66 percent of participants receiving monthly tobevibart and elebsiran achieved hepatitis delta virus RNA target not detected, including participants with cirrhosis and high baseline viral loads. The combination was well-tolerated with no grade 3 or higher treatment-related adverse events.
Tobevibart is a broadly neutralizing monoclonal antibody targeting hepatitis B surface antigen to prevent viral entry and reduce circulating viral particles. Elebsiran is a small interfering RNA targeting hepatitis B virus RNA transcripts with potential antiviral activity against both hepatitis B and delta viruses. Both are administered subcutaneously.
The combination has received Breakthrough Therapy and Fast Track designations from the FDA and PRIME and orphan drug designations from the EMA.
