Overview
In June 2010, sanofi-aventis and Regulus Therapeutics entered into the largest-to-date strategic alliance on microRNA therapeutics. The alliance represents the largest microRNA partnership formed to date, valued at potentially over $750 million, and includes a $25 million upfront fee, a $10 million future equity investment subject to mutual agreement on company valuation, and annual research support for three years with the option to extend two additional years. The alliance will initially focus on the therapeutic area of fibrosis. Regulus and sanofi-aventis will collaborate on up to four microRNA targets, including Regulus' lead fibrosis program targeting microRNA-21. Regulus also could receive preclinical milestones as well as development and sales milestones for collaboration targets. In addition, Regulus is eligible to receive royalties on microRNA therapeutic products commercialized by sanofi-aventis. sanofi-aventis will support 100% of the costs of development and commercialization. In addition, Regulus has granted sanofi-aventis an option to enter into a technology alliance worth $50 million that could provide sanofi-aventis with access to Regulus' microRNA platform and a limited number of product licenses. Assuming exercise of the technology alliance option, Regulus has certain opt-in rights to participate in the development and commercialization of future sanofi-aventis clinical microRNA programs. In addition, Regulus is eligible to receive milestone payments and royalties on microRNA therapeutic products developed and commercialized under the technology alliance option.
In April 2008, GSK and Regulus Therapeutics announced the first ever microRNA-focused strategic alliance to discover, develop and commercialize novel microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory disease. Valued at nearly $600 million, the alliance provides GSK with an option to exclusively license drug candidates directed at four different microRNA targets with relevance in inflammatory disease. Regulus is responsible for the discovery and development of the microRNA antagonists through completion of clinical proof of concept. GSK has the option to license each drug developed by Regulus for the relevant microRNA target for further development and commercialization on a worldwide basis.
In February 2010, GSK and Regulus Therapeutics announced a new collaboration to develop and commercialize microRNA therapeutics targeting microRNA-122 for the treatment of Hepatitis C Infection. 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. Regulus exclusively controls patent rights covering miR-122 antagonists and their uses as HCV therapeutics. 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.
