Sanofi-Aventis and Regulus Therapeutics Form Major Strategic Alliance on microRNA Therapeutics
Last update: 6/22/2010 6:00:01 AM
- Largest microRNA therapeutics alliance to date, valued at potentially over $750 million including a $25 million upfront, a $10 million future equity investment subject to mutual agreement on company valuation, and a three-year option worth $50 million for a broader technology alliance
- CARLSBAD, Calif., Jun 22, 2010 (BUSINESS WIRE)
-- Focused on developing microRNA-based medicines toward four targets -
--- Structured as multi-year collaboration intended to advance several investigational new drugs into clinical development
- Regulus Therapeutics Inc. and sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that they have entered into a global, strategic alliance to discover, develop, and commercialize 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. sanofi-aventis also receives an option for a broader technology alliance that provides Regulus certain rights to participate in development and commercialization of resulting products. If exercised, this three-year option is worth an additional $50 million to Regulus. microRNAs are a new class of small non-coding RNAs that regulate gene expression by interfering with translation or stability of target messenger RNA transcripts.
Endogenous microRNAs regulate the expression of over one-third of all human genes, and the association of microRNA dysfunction with disease phenotypes has given rise to an entirely new class of pharmaceutically relevant targets. In preclinical studies, Regulus has demonstrated that modulating microRNAs can effectively regulate disease pathways and produce therapeutically beneficial effects. "This new partnership continues to illustrate sanofi-aventis' commitment to develop innovative therapies," declared Marc Cluzel, M.D., Ph.D, Executive Vice-President, Research & Development, sanofi-aventis. "microRNAs are believed to be extremely important in human development and physiology. Together with Regulus we will develop therapeutics which could potentially open a new paradigm in the treatment of major diseases and could offer an attractive new therapeutic approach for patients."
"Regulus is very pleased to form this landmark alliance with sanofi-aventis, a leading visionary company developing important new medicines," said Kleanthis Xanthopoulos, Ph.D., President and Chief Executive Officer of Regulus. "The significant support from sanofi-aventis in this new alliance will strengthen our efforts as we continue to build the leading microRNA therapeutics company through our commitment to scientific excellence and advancement of our pipeline of innovative new medicines.
Indeed, this landmark alliance will significantly extend our capabilities and resources to lead the discovery and development of microRNA therapeutics."
Alnylam Pharmaceuticals (ALNY) and Isis Pharmaceuticals (ISIS) formed Regulus in 2007, with each company currently owning approximately 50% of the preferred stock. About the Regulus and sanofi-aventis Collaboration Regulus and sanofi-aventis have entered into a strategic alliance on microRNA therapeutics.
The alliance is initially focused on the therapeutic area of fibrosis. Regulus has granted sanofi-aventis four worldwide, exclusive licenses to discover, develop, and commercialize microRNA therapeutics, including Regulus' leading fibrosis program targeting microRNA-21.
Regulus receives from sanofi-aventis an upfront fee of $25 million, a future equity investment of $10 million subject to mutual agreement on company valuation, and annual research funding for three years with the option to extend for two additional one-year periods.
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 clinical development and commercialization of each program.
In addition, Regulus has granted sanofi-aventis an option to enter into a technology alliance worth up to $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.
The alliance is valued at potentially over $750 million in consideration of upfront payments, equity investment, research funding, and potential preclinical, clinical and commercial milestone payments for multiple products if all products are successfully commercialized.
Regulus will pay approximately $4 million of the initial funding to its licensors, the majority of which will be to Isis and Alnylam. Isis and Alnylam could also receive additional payments based on future success-based milestone payments earned during the alliance.
DRW