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Regulus, Sanofi Renew microRNA Drug Alliance under New Terms

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Regulus Therapeutics this week announced that Sanofi has renewed the companies' strategic alliance to discover and develop microRNA therapeutics for cancer and certain orphan diseases.

Under the new arrangement, Regulus will take over the drug candidates' initial development, with Sanofi having the right to take over development and commercialization following clinical proof of concept.

The companies began working together in 2010, when Sanofi picked up the rights to use Regulus technology to develop and commercialize four miRNA-targeting drugs, including a fibrosis treatment targeting miR-21, in exchange for $25 million up front and the promise of a $10 million equity investment, research funding, milestones, and royalties.

That arrangement expired in June, but included an option giving Regulus and Sanofi extra time to come to terms on another contract.

According to Regulus, it is now in charge of developing a miR-21-targeting candidate for Alport Syndrome, a rare fibrotic condition of the kidneys. Regulus is also now leading the development of cancer drug candidates targeting miR-21 and miR-221/222.

In a filing with the US Securities and Exchange Commission, Regulus said it will be required to advance these products through human proof of concept, incurring all related costs. Sanofi has the right, but not the obligation, to perform complementary development activities to assist Regulus.

For any candidate that achieves human proof of concept, Sanofi has the option to exclusively take over its development and commercialization worldwide. Regulus will have the option to co-promote any such compound in the US.

For each drug that it options, Sanofi will reimburse Regulus for "a significant portion of the preclinical and clinical development costs" incurred with its development, as well as pay an option exercise fee.

Regulus is also eligible to receive milestone payments on candidates Sanofi licenses, as well as royalties on product sales that are significantly higher than those spelled out under the firms' original deal.

Regulus will regain the full, exclusive rights to any candidates Sanofi declines to option.

In conjunction with the signing of the new agreement, Sanofi made a $10 million equity investment in Regulus.

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