Tobevibart

The two companies will share costs on Vir\'s ongoing studies, one of which will pit the candidate head-to-head against Gilead\'s approved offering.\n Vir Biotechnology is handing off certain commercial rights for its hepatitis D program to European specialty pharma Norgine in a licensing deal that’s worth up to €550 million ($645 million) and still leaves the untapped U.S. market to Vir.Norgine will shell out €55 million ($64 million) upfront for the prospective chronic hepatitis delta (hepatitis D or HDV) combo of Vir’s monoclonal antibody tobevibart and Alnylam-discovered siRNA elebsiran. The deal also puts Vir in line for up to €495 million ($581 million) in clinical, regulatory and sales milestones, plus tiered royalties from Norgine’s licensed sales territories in Europe, Australia and New Zealand.Vir, meanwhile, will retain all commercialization rights in the U.S. and other markets outside of the greater China territory, according to a Tuesday press release. The two companies will share clinical development costs for Vir’s ongoing Eclipse trial program, with Norgine responsible for about 25% of external costs going forward. With that, Vir expects to extend its cash runway through the last quarter of 2027. The company chose Norgine for its “ideal expertise and reach in key international markets” that could maximize the impact of the treatment, CEO Marianne De Baker, Ph.D., commented in the release.“This agreement advances our commitment to sustainably develop and commercialize the tobevibart and elebsiran combination treatment globally while advancing our innovative clinical pipeline,” Baker said.Mid-stage data from Vir’s HDV program has already shown that it could make for a considerable threat in the limited drug arena. Across 32 participants dosed in Vir’s phase 2 Solstice trial, 66% met and sustained rates of HDV RNA target not detected at 48 weeks, an endpoint that means no active HDV RNA was found in a blood sample. 90% of patients studied saw a reduction in hepatitis B surface antigen, which points to suppression for the core biological mechanisms required for HDV viral replication.CHD is the most severe form of chronic viral hepatitis and can only infect people if the hepatitis B virus is present. By combining tobevibart, a neutralizing monoclonal antibody, with the liver-directed hepatitis B surface antigen-reducing design of elebsiran, Vir looks to treat the disease by tackling its viral lifecycle through multiple mechanisms, Norgine explained in its own press release.Norgine, which has a “rich history in hepatology and specialty care,” highlights the deal as affirming its position as a “partner-of-choice for companies seeking a trusted collaborator in Europe, Australia and New Zealand,” CEO Janneke van der Kamp noted.Next up for the tobevibart-elebsiran pair is Eclipse 3, a phase 2b trial that pits the two head-to-head with Gilead’s bulevirtide. Bulevirtide, commercialized as Hepcludex in Europe, is one of the few treatments available for the disease. However, the drug hasn’t yet reached the U.S. due to an FDA complete response letter in 2022, leaving Vir and other prospective HDV drugmakers racing to be the first to unlock the U.S. market. Earlier this month, Mirum Pharmaceuticals showed that it also has its eye on the HDV prize with a $620 million buy of Bluejay Therapeutics and its HDV prospect, brelovitug. In a phase 2 study, brelovitug demonstrated 100% HDV RNA response plus improvements in liver enzyme levels. 

– 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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