Brelovitug

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.