Vir Biotechnology grants Norgine exclusive license to CHD treatment in Europe

The company states: “Vir Biotechnology (VIR) announced that the Company has granted Norgine Pharma UK Limited, an affiliate of Norgine, a leading European specialty pharmaceutical company, an exclusive license for the commercial rights to the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta, CHD, in Europe, Australia and New Zealand. Per the terms of the agreement, Vir Biotechnology will receive an initial reimbursement payment of EUR 55 million and is eligible to receive up to EUR 495 million in clinical, regulatory and sales milestones, and tiered, mid-teen to high-twenties percent royalties on net sales in Norgine’s licensed territory. Vir Biotechnology retains all commercialization rights for tobevibart and elebsiran in the United States and other markets outside of the Greater China Territory.1 In addition, clinical development costs for the ongoing trials in Vir Biotechnology’s ECLIPSE registrational program will be shared, with Norgine contributing approximately 25% of go-forward external costs. As a result of this agreement, Vir Biotechnology expects that current cash, cash equivalents and investments will be extended into the fourth quarter of 2027, based on the current operating plan. Vir Biotechnology also confirmed completion of enrollment for ECLIPSE 3, a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naive patients. ECLIPSE 3 is designed to provide important supportive data to help establish access and reimbursement in Europe and other key geographies. Forty-eight week data from the Phase 2 SOLSTICE trial presented last month at the American Association for the Study of Liver Diseases The Liver Meeting(R) and simultaneously published in the New England Journal of Medicine demonstrated that two thirds (66%, 21/32) of participants receiving a monthly dose of the combination of tobevibart and elebsiran achieved hepatitis delta virus RNA target not detected. Importantly, the combination regimen achieved a high proportion of TND in participants with cirrhosis and high baseline HDV RNA. The combination was well-tolerated, with no grade 3 or higher treatment-related adverse events and no treatment-related discontinuations.”