GSK, Regulus Therapeutics Form MicroRNA Alliance

GlaxoSmithKline and Regulus Therapeutics have entered into a worldwide strategic alliance to discover, develop and market novel microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Regulus is a joint venture between Alnylam Pharmaceuticals and Isis Pharmaceuticals.
   
The alliance leverages Regulus’ expertise and intellectual property in the discovery and development of microRNA-targeted therapeutics and provides GSK with an option to license product candidates directed at four different microRNA targets in inflammatory disease. Regulus will be responsible for the discovery and development of the microRNA antagonists through clinical proof of concept, unless GSK chooses to exercise its option earlier. If GSK exercises this option, the company will have an exclusive license to drugs developed under each Regulus program for further development and commercialization on a worldwide basis. Regulus will have the right to further develop and commercialize any microRNA therapeutics that GSK chooses not to develop.
   
Regulus will receive $20 million in upfront payments from GSK, including a $15 million option fee and a $5 million note (guaranteed by Isis and Alnylam) that will convert into Regulus common stock under certain specified circumstances. Regulus could be eligible to receive as much as $144.5 million in development, regulatory and sales milestone payments for each of the four therapeutics discovered and developed as part of the alliance. Regulus could also receive nearly $600 million in option, license and milestone payments, as well as tiered royalties on worldwide sales of products resulting from the alliance.
   
“We are focused on finding innovative medicines through both internal efforts and by ‘virtualizing’ a portion of the inflammatory diseases pipeline. We are very excited to be working with Regulus and exploring the therapeutic opportunities in inflammation offered by targeting microRNAs, an exciting new area of biology,” said Jose Carlos Gutierrez-Ramos, Ph.D., senior vice president and head of the Immuno-Inflammation Center of Excellence for Drug Discovery of GSK.
   
“GSK is an outstanding partner for Regulus, and we look forward to expanding our efforts in inflammation where a new class of therapeutics could offer novel options to treat disease,” said Kleanthis G. Xanthopoulos, Ph.D., president and chief executive officer of Regulus.