Tobevibart

– Vir Biotechnology to receive EUR 55 million initial reimbursement payment upon closing, and up to EUR 495 million in clinical, regulatory and sales milestones, along with tiered, mid-teen to high-twenties percent royalties on net sales – Companies to share clinical development costs for ongoing ECLIPSE registrational program with Norgine contributing approximately 25% of go-forward external costs – ECLIPSE 3, designed to support access and reimbursement in Europe and other key geographies, has completed enrollment SAN FRANCISCO--(BUSINESS WIRE)-- Vir Biotechnology, Inc. (Nasdaq: VIR) today 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 (ECLIPSE 1, 2 and 3) 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. “We believe Norgine has the ideal expertise and reach in key international markets to maximize the impact of our investigational treatment for CHD,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “People living with this devastating disease deserve efficacious, safe and convenient treatment options. This agreement advances our commitment to sustainably develop and commercialize the tobevibart and elebsiran combination treatment globally while advancing our innovative clinical pipeline.” The combination of tobevibart and elebsiran is a potentially first-of-its-kind therapy for the treatment of CHD, bringing together an investigational human monoclonal antibody and a small interfering RNA (siRNA) with the goal of disrupting the viral lifecycle through multiple mechanisms. The combination is currently under evaluation for the treatment of CHD in Vir Biotechnology’s ECLIPSE registrational program. 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-naïve 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 (AASLD) The Liver Meeting® 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 (HDV) RNA target not detected (TND). 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. “We are excited to collaborate with Vir Biotechnology to advance care in CHD and improve patient access to this innovative therapy,” said Janneke van der Kamp, Chief Executive Officer, Norgine. “By combining our expertise in hepatology and specialty care with cutting-edge science from Vir Biotechnology, we are reinforcing our commitment to improving healthcare outcomes. Collaborations like this affirm Norgine’s position as a partner-of-choice for companies seeking a trusted collaborator in Europe, Australia and New Zealand.” The closing of this transaction with respect to certain jurisdictions outside the United States is subject to Norgine receiving regulatory approval from applicable authorities as may be required. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta (CHD). Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with CHD. The combination of tobevibart and elebsiran has been granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA), and Priority Medicines (PRIME) and orphan drug designations by the European Medicines Agency (EMA). About Chronic Hepatitis Delta (CHD) CHD is the most severe form of chronic viral hepatitis2 and was recently classified as carcinogenic by the International Agency for Research on Cancer.3 People living with the disease rapidly progress to cirrhosis, liver failure4 and liver-related death.2 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a portfolio of preclinical programs across a range of infectious diseases and oncologic malignancies. 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Agreement underscores Norgine's mission to bring innovative therapies to patients and builds on our heritage in hepatology and specialty pharmaceuticals. Vir Biotechnology's chronic hepatitis delta treatment candidate has shown robust virological responses and reflects a differentiated approach to treatment. UXBRIDGE, England, Dec. 17, 2025 /PRNewswire/ -- Norgine, a leading European specialty pharmaceutical company, today announced an exclusive licensing agreement 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 the necessary marketing authorisations. There is a high unmet medical need for effective treatments for CHD given potential limitations with existing treatment options. Under the terms of the licensing agreement, Vir Biotechnology will receive a EUR 55 million initial reimbursement payment and up to EUR 495 million in potential regulatory and commercial milestone payments. Additionally, Vir Biotechnology will receive tiered, mid-teen to high-twenties percent royalties on net sales in Norgine's licensed territories. Clinical development costs for the ongoing trials in Vir Biotechnology's ECLIPSE registrational program (ECLIPSE 1, 2 and 3) will be shared, with Norgine contributing a percentage of go-forward external costs. Norgine will be responsible for all commercialisation activities and will hold all marketing authorisations in its licensed territories. The closing of this transaction with respect to certain jurisdictions outside the United States is subject to Norgine receiving regulatory approval from the applicable authorities as may be required. "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, Chief Executive Officer of Norgine. "By combining our proven commercial and regional expertise with cutting-edge science from Vir Biotechnology, we are reinforcing our commitment to improving healthcare outcomes. Collaborations like this affirm Norgine's position as a partner-of-choice for companies seeking a trusted collaborator in Europe, Australia and New Zealand." "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, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "Norgine's proven track record in specialty medicines across Europe, Australia and New Zealand complements our clinical development mettle and ongoing registrational efforts. Together, we aim to broaden access and improve outcomes for people living with this severe disease." The combination of tobevibart and elebsiran offers the potential to treat the disease by tackling the viral lifecycle through multiple mechanisms. Tobevibart is an investigational neutralising monoclonal antibody that has been engineered for immune engagement. Elebsiran is an investigational small interfering RNA (siRNA) that is designed to enable targeted delivery to the liver and to reduce hepatitis B surface antigen, a protein which is required for the hepatitis D virus life cycle. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology's proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor's Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta (CHD). The combination of tobevibart and elebsiran has been granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA), and Priority Medicines (PRIME) and orphan drug designations by the European Medicines Agency (EMA). About Chronic Hepatitis Delta (CHD) CHD is the most severe form of chronic viral hepatitis1 and was recently classified as carcinogenic by the International Agency for Research on Cancer.2 People living with the disease rapidly progress to cirrhosis, liver failure3 and liver-related death.1 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally. About Norgine Norgine is a mid-sized EU-based pharmaceutical company with 1,500 employees, generating approximately $600 million in annual sales. At Norgine, innovation drives our mission to deliver medicines that change lives. From common conditions like constipation to rare and severe diseases such as childhood cancer, we target unmet medical needs because we believe that every scientific breakthrough deserves to reach patients in need. We use our innovative development, commercialisation and manufacturing capabilities as well as strategic partnerships to navigate complex pathways. Combined with our extensive history and deep regional expertise, this approach allows us to accelerate and expand the reach of life-changing medicines across Europe, Australia, and New Zealand. We are guided by the trust that healthcare professionals and patients place in us and remain committed to delivering innovation that transforms lives, one patient at a time. References: 1 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D - NIDDK (nih.gov), accessed September 2025 2 Karagas, Margaret R et al., Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus, The Lancet Oncology, Volume 26, Issue 8, 994 – 995. 3 CDC What is Hepatitis D - FAQ | CDC, accessed September 2025 Forward-Looking Statements This press release contains forward-looking statements, including statements regarding our future operations, strategy, plans, objectives, and anticipated product launches. Forward-looking statements are based on current expectations and assumptions and involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Words such as "anticipate", "believe", "expect", "intend", "may", "plan", "seek", and similar expressions identify such statements. Factors that could cause actual results to differ include, among others: regulatory approvals, clinical development outcomes, manufacturing and supply chain risks, market acceptance, competitive dynamics, and changes in applicable laws. Forward-looking statements speak only as of the date of this release. Norgine undertakes no obligation to update or revise any forward-looking statements, except as required by law. Logo - SOURCE Norgine Pharmaceuticals Limited 21% more press release views with Request a Demo