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news.Regulus Therapeutics has collaborated with GlaxoSmithKline (GSK) to develop and commercialize microRNA therapeutics targeting microRNA-122 in all fields with hepatitis C viral infection (HCV) as the lead indication.
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miR-122 is a liver-expressed microRNA that has been shown to be a critical endogenous ‘host factor’ for the replication of HCV and anti-miRs targeting miR-122 have been shown to block HCV infection.
Under the terms of collaboration, Regulus will receive additional upfront and early-stage milestone payments with the potential to earn more than $150m in miR-122-related combined payments, and tiered royalties up to double digits on worldwide sales of products.
The collaboration provides GSK with access to Regulus’ comprehensive and robust intellectual property estate. Regulus exclusively controls patent rights covering miR-122 antagonists and their use as HCV therapeutics in the US, Europe, and Japan, including but not limited to the patent families which encompass: the ‘Sarnow’ patent pertaining to the method of use of anti-miR-122 to inhibit HCV replication, the ‘Esau’ patent application claiming the use of anti-miRs targeting miR-122 as inhibitory agents, the ‘Tuschl III’ patent claiming composition of matter for miR-122 and complementary oligonucleotides, and the ‘Manoharan’ patent claiming antagomirs, including antagomirs targeting miR-122.
Kleanthis Xanthopoulos, president and chief executive officer of Regulus, said: “This new collaboration with GSK demonstrates the clear scientific leadership that Regulus has established in advancing a whole new frontier of pharmaceutical research. microRNA therapeutics target the pathways of human diseases, not just single disease targets, and hold considerable promise as novel therapies across a broad range of unmet medical needs.
“It also further validates Regulus’ microRNA product platform built on fundamental biology of human diseases and intellectual property, and also extends the therapeutic scope of our existing collaboration formed with GSK in 2008. Furthermore, the funding from this alliance supports Regulus’ efforts in advancing high impact, novel medicines based on microRNA biology to patients.”