Glaxo's triple play

Regulus’ connection to Isis and Alnylam is an irresistible IP combo for GSK

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CARLSBAD, Calif.—Regulus Therapeutics LLC and London-based GlaxoSmithKline (GSK) have entered into a worldwide strategic alliance potentially worth more than half a billion dollars to Regulus 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 Inc. and Isis Pharmaceuticals Inc.
Under the terms of the deal, 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 in the future under certain specified circumstances. Regulus could also be eligible to receive up to $144.5 million in development, regulatory and sales milestone payments for each of the four miRNA-targeted therapeutics discovered and developed as part of the alliance.

In addition to the potential of nearly $600 million in option, license and milestone payments, Regulus would also receive tiered royalties up to double digits on worldwide sales of products resulting from the alliance.
"This deal puts us on the map as the undisputed leader in microRNA work with the recognition of company the magnitude of GSK," says Dr. Kleanthis G. Xanthopoulos, president and CEO of Regulus Therapeutics. "It also allows us to have a program in inflammation that we wouldn't have been able to pursue otherwise—certainly not at this level—without Glaxo's resources added to ours."

Regulus will be responsible for the discovery and development of the miRNA antagonists through completion of clinical proof of concept, unless GSK chooses to exercise its option earlier. After exercise of the option, GSK will have an exclusive license to drugs developed under each program by Regulus for the relevant miRNA target for further development and commercialization on a worldwide basis. Regulus will have the right to further develop and commercialize any miRNA therapeutics which GSK chooses not to develop or commercialize.

Regulus offers a unique set of expertise and intellectual property, Xanthopoulos notes. "What Glaxo gets, really, is a relationship with three companies, with Regulus at the forefront. Because while Regulus itself is a young joint venture company, it brings a large number of years of experience in antisense from Isis and RNAi expertise from Alnylam. You can't find a package of resources like this anywhere else."

"We are focused on finding innovative medicines through both internal efforts and by 'virtualizing' a portion of the inflammatory diseases pipeline," said Dr. Jose Carlos Gutierrez-Ramos, senior vice president and head of the Immuno-Inflammation Center of Excellence for Drug Discovery of GSK, in a news release about the deal. "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. When associated with an aberrant inflammatory response, microRNAs represent disease targets whose therapeutic modulation could revolutionize the way we treat immune diseases and provide benefits not readily achievable with today's medicines."

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