Regulus renews strategic alliance with Sanofi to focus on orphan disease and oncology targets

Regulus will lead development of its fibrosis program targeting microRNA-21 (miR-21) for the treatment of Alport Syndrome, an orphan, life-threatening genetic kidney disease with no approved therapy, and for its miR-21 program in oncology.

Sanofi has retained its interest in these microRNA-21 programs and has gained rights to Regulus’ preclinical program targeting microRNA-221/microRNA-222 (miR-221/222).

Regulus is responsible for advancing the clinical candidates in these programs to proof-of-concept. Sanofi shall have the exclusive option, exercisable after proof-of-concept, to take over further development and commercialization of each microRNA therapeutic program. At this stage, Regulus will have the option to co-promote any microRNA therapeutic product in the United States.

Regulus president and CEO Dr Kleanthis G. Xanthopoulos noted the renewal of the company’s strategic relationship with Sanofi further underscores the commitment of both companies to realize the tremendous promise of RNA therapeutics and the possibility to transform the field of drug discovery by targeting microRNAs.

"We believe that Regulus’ microRNA therapeutic platform, coupled with our focus on orphan diseases and oncology indications, combine perfectly with Sanofi’s resources and their proven capabilities as a global-healthcare leader to bring innovative medicines to patients in need. We look forward to advancing our programs together and building a meaningful clinical portfolio," Dr Xanthopoulos added.

The refocused relationship allows Sanofi and Regulus to continue to collaborate on several meaningful microRNA therapeutic programs, with a greater focus on orphan diseases and oncology. Under the original agreement from 2010, Sanofi had rights on up to four microRNA targets, which included Regulus’ lead fibrosis program targeting miR-21.

In 2012, the companies expanded the alliance to collaborate on an oncology program targeting miR-21. In 2013, the companies entered into an option letter agreement to allow for negotiation of the extended strategic alliance announced today. Sanofi retained its interest in developing microRNA-21 therapeutics for fibrosis and oncology indications and now has opt-in rights to Regulus’ miR-21 and miR-221/222 program. If Sanofi chooses to exercise its option on any of these programs, Sanofi will reimburse Regulus for a significant portion of its preclinical and clinical development costs.

Regulus continues to be eligible to receive royalties on microRNA therapeutic products commercialized by Sanofi.

Additionally, Sanofi has increased its ownership stake in Regulus through an additional $10m common stock investment at $7.67 per share, which represents the volume-weighted average share price over the last 30 trading days.