GSK's Dovato wins EU approval; RedHill secures speedy review for H. pylori drug
→ About two months after winning speedy US approval for its dual HIV regimen — Dovato — GSK’s ViiV has secured the European nod. GSK’s $GSK approach to grabbing market share from Gilead $GILD — which currently dominates the HIV market that is estimated to hit $22.5 billion by 2025 — is to convince regulators, doctors and patients to adopt its two-drug regimen, versus Gilead’s triple-drug cocktails, that could potentially result in fewer toxic side-effects, reduce dosing frequency, and be more cost-effective — although critics suggest that this may not be the most effective strategy because the virus will only have to fight against two drugs which could culminate in drug resistance.
→ After two positive pivotal studies, RedHill Biopharma‘s drug Talicia has been accepted for review as a treatment for H. pylori infection. The Israeli company’s application has been granted priority review by the FDA, and the agency is expected to make its decision by November 2.
→ Arbutus Biopharma $ABUS — whose lipid nanoparticle (LNP) technology was licensed to Alnylam $ALNY in 2012 — is selling off a part of its royalty interest on future global net sales of Alnylam’s 2018-approved RNAi therapy for hereditary transthyretin-mediated amyloidosis, Onpattro, to one of Canada’s largest defined benefit pension plans. OMERS is giving Arbutus $20 million in gross proceeds. “This monetization opportunity is valuable for us as it both extends our runway with non-dilutive capital and maintains valuable downstream royalties,” said Arbutus chief business officer Michael McElhaugh in a statement.