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Feb 25, 2010

GSK and Regulus to Collaborate on miRNA-Based HCV Drugs

  • GlaxoSmithKline (GSK) obtained access to Regulus Therapeutics’ miR-122 antagonist patent estate as part of a potentially $150 million collaboration to develop new miRNA therapeutics against HCV and possibly other diseases. As part of the deal Regulus will receive an up-front fee along with milestone payments and royalties on worldwide product sales. Regulus aims to identify a clinical candidate during the second half of 2010 and potentially file an IND application in 2011.

    miR-122 is a liver-expressed miRNA that has been found to represent a critical endogenous host factor for the replication of HCV, the companies explain. Regulus also reports that its research has confirmed that inhibiting miR-122 results in significant inhibition of HCV replication in human cells.

    Regulus is a joint venture between Alnylam Pharmaceuticals and Isis Pharmaceuticals. According to Kleanthis G. Xanthopoulos, Ph.D., president and CEO, the collaboration with GSK “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 and GSK set up their partnership for the discovery, development, and marketing of novel miRNA-targeted therapeutics against inflammatory diseases in April 2008. Regulus’ in-house pipeline includes candidates against cancer, cardiovascular disorders, and fibrosis.


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