Servier and miRNA drugs firm miRagen Therapeutics signed a development and commercialization deal centered on two of the latter’s lead cardiovascular programs targeting MiR-208 and miR-15/195, and an additional cardiovascular disease target that has yet to be identified. miRagen will receive up to $45 million in total up-front, research support, and near-term milestone payments over the next three years.
Under terms of the agreement, miRagen and Servier will collaborate on R&D, and Servier will shoulder all costs associated with global development and regulatory commercialization activities for the three products worldwide, excluding the U.S. and Japan, where miRagen retains all rights.
Additional payments relating to clinical development support, combined with clinical and commercial milestones, could take the value of the deal up to $1 billion for all three programs combined. Of this potential $1 billion total value of the deal, miRagen says it could receive regulatory and commercial milestones of $352 million, plus double-digit royalties on sales by Servier outside the U.S. and Japan.
“Our agreement with Servier not only provides validation of our lead programs in cardiac disease, but further underscores the potential of our innovative technology platform,” comments William S. Marshal, Ph.D., president and CEO at miRagen.
Founded in 2007, miRagen is exploiting its core capabilities in miRNA profiling, oligonucleotide medicinal chemistry, cellular analysis, and in vivo testing to identify modulators of miRNAs in disease-specific pathways. The firm’s lead preclinical programs are based on locked nucleic acid (LNA) technology licensed to miRagen from Santaris Pharma in 2010, and the deal with Servier essentially expands miRagen’s agreement with Santaris to allow the development of additional targets and provide Servier with access to the LNA technology.
miRagen’s antimiR-208 candidate is being developed on the back of research demonstrating that inhibiting this miRNA may improve cardiac function and survival rates during heart failure. The firm says chemically synthesized miR-208 inhibitors have been shown to suppress pathological cardiac remodeling, while enhancing cardiac function and survival. The antimiR-15/195 program is being developed as a result of research indicating that inhibiting miR-15 stimulates cardiomyogenesis, and spares cardiomyocytes from death during myocardial infarction.
Additional preclinical antimiR and promiR programs are ongoing in therapeutic areas including polycythemia vera, cardiac fibrosis, peripheral arterial disease, cardiometabolic disease, vascular disease, and amyotrophic lateral sclerosis.
In August miRagen and preclinical contract research organization RxGen were awarded a $720,000 Small Business Innovation Research grant by the National Heart Lung and Blood Institute to support continued preclinical research on microRNA targeting in cardiovascular disease and help to establish a novel model system of chronic heart failure.
In addition to its collaborations with Santaris and now Servier, miRagen also has separate ongoing partnerships with t2cure, which gives miRagen exclusive rights to IP centered on the neoangiogenesis regulator miR-92, and with RXi, to evaluate the potential utility of the latter’s rxRNA technology against specific cardiac and neuromuscular miRNA targets of interest to miRagen.