Workflow
bulevirtide
icon
Search documents
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
Businesswire· 2025-12-16 21:05
Core Viewpoint - Vir Biotechnology has entered into an exclusive licensing agreement with Norgine Pharma UK Limited for the commercial rights to the combination treatment of tobevibart and elebsiran for chronic hepatitis delta (CHD) in Europe, Australia, and New Zealand, which is expected to enhance the commercialization efforts and extend the company's financial runway into Q4 2027 [1][2][5]. Financial Terms - Vir Biotechnology will receive an initial reimbursement payment of EUR 55 million and is eligible for up to EUR 495 million in clinical, regulatory, and sales milestones, along with tiered royalties on net sales in the licensed territory [1]. - Norgine will contribute approximately 25% of the ongoing external clinical development costs for the ECLIPSE registrational program [1]. Product Development - The combination of tobevibart and elebsiran is being evaluated as a potentially first-of-its-kind therapy for CHD, utilizing a human monoclonal antibody and a small interfering RNA (siRNA) to disrupt the viral lifecycle [2]. - Enrollment for the ECLIPSE 3 trial has been completed, which is a Phase 2b head-to-head trial comparing the combination treatment with bulevirtide in bulevirtide-naïve patients [3]. Clinical Data - Data from the Phase 2 SOLSTICE trial indicated that 66% of participants receiving the combination treatment achieved hepatitis delta virus (HDV) RNA target not detected (TND) after 48 weeks, with a high proportion of TND observed in patients with cirrhosis [4]. Regulatory Designations - The combination treatment has received Breakthrough Therapy and Fast Track designations from the U.S. FDA, as well as Priority Medicines (PRIME) and orphan drug designations from the European Medicines Agency (EMA) [9]. Market Context - Chronic Hepatitis Delta (CHD) is recognized as the most severe form of chronic viral hepatitis, with no approved treatments currently available in the U.S. and limited options in the European Union and globally [10].