Regulus, GSK Enter HCV Development Pact

Regulus Therapeutics has entered into a new collaboration with GlaxoSmithKline to develop and commercialize microRNA therapeutics targeting microRNA-122 in Hepatitis C Viral infection (HCV). Regulus will receive additional upfront and early-stage milestone payments with the potential to earn more than $150 million in miR-122-related combined payments, as well as royalties on worldwide product sales. In exchange, GSK will have access to Regulus’ comprehensive intellectual property. Regulus’ patent rights cover miR-122 antagonists and their use as HCV therapeutics in the U.S., Europe, and Japan.

“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 hold considerable promise as novel therapies across a broad range of unmet medical needs,” said Kleanthis G. Xanthopoulos, Ph.D., president and chief executive officer of Regulus. “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.”

Regulus scientists and collaborators believe that inhibiting miR-122 results in significant inhibition of HCV replication in human liver cells, suggesting that antagonism of miR-122 may comprise a novel “host factor” therapeutic strategy. Preclinical studies have shown a robust HCV antiviral effect following inhibition of miR-122. Regulus plans to identify a clinical development candidate in 1H10 and file an IND application in 2011.