Miragen retains all U.S. and Japanese commercialization rights; Servier gains rights to all other global markets
Servier to fund multi-year research and development plan on various targets and all preclinical and clinical development costs through Phase II for the compounds
Miragen retains option to co-sponsor Phase III or opt in after completion and refund part of the cost
Miragen to receive regulatory and commercial milestones of approximately $352 million and double-digit royalties on product sales in markets outside the U.S. and Japan
Total deal value approximately $1 billion including development support and payments to Miragen
SURESNES, France, and BOULDER, Colo., October 18, 2011 – Les Laboratoires Servier, a leading European pharmaceutical company with expertise in innovative treatments for cardiovascular diseases, and Miragen Therapeutics, Inc., a preclinical-stage biopharmaceutical company focused on improving patients’ lives by developing innovative microRNA (miRNA)-based therapeutics for cardiovascular and muscle disease, announced today an agreement for advancing the research, development and commercialization of three drug candidates, including two of miRagen’s lead programs (miR-208 and miR-15/195) and one additional target yet to be identified, for cardiovascular disease. This partnership provides worldwide rights, excluding the U.S. and Japan, to Servier.
Under the terms of the agreement, Miragen will receive up to $45 million in total upfront, research support and near-term milestone payments over the next three years, as well as royalties on sales, based on the successful outcome of the collaboration. Additional clinical and commercial milestones, as well as clinical development support for the successful development of the three compounds, would value the deal at approximately $1 billion. Miragen and Servier will collaborate on the research and development effort, while Servier alone will be responsible for all costs associated with the global development, regulatory approval and commercialization of the three product candidates worldwide, excluding the U.S. and Japanese markets. Miragen retains all rights in the U.S. and Japan, and the option to co-sponsor any Phase III programs in the event that Miragen, alone or together with a partner, should seek marketing approvals for any of the targets in the U.S. and Japan.
“We are very pleased with this new partnership, which demonstrates once again our ability to explore truly innovative treatments for patients suffering from cardiovascular diseases. Indeed, these diseases still represent the number one cause of mortality in most of the world,” said Emmanuel Canet, M.D., Ph.D., Head of Servier R&D.
“More and more evidence is gathering to show that some microRNAs are not only cardiovascular biomarkers, but they also play a significant role in the pathogenesis of various diseases from heart failure to coronary disease,” added Dr. Jean-Paul Vilaine, Head of Servier’s Cardiovascular Unit.
“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 to deliver compelling drug candidates,” said William S. Marshall, Ph.D., President and Chief Executive Officer of Miragen Therapeutics, Inc. “We are delighted to partner with Servier, whose demonstrated leadership and expertise in the development of cardiovascular drugs are truly impressive. By combining our strengths, we hope to translate the potential of microRNA targeting into life-changing medicines for patients in need.”
Miragen’s lead programs utilize Santaris Pharma A/S’ Locked Nucleic Acid (LNA) Drug Platform. In June 2010, Miragen licensed the rights to utilize Santaris Pharma A/S proprietary LNA Drug Platform to identify and select drug candidates against Miragen’s proprietary microRNA targets for the treatment of cardiovascular disease. This agreement has now been expanded to allow Miragen to develop additional targets and provide Servier access to Santaris Pharma’s LNA technology.
“We are pleased to expand our alliance with Miragen to include additional cardiovascular targets and provide access to Santaris Pharma’s LNA technology in order to help Servier and Miragen to develop LNA-based microRNA-targeted drugs for the treatment of cardiovascular disease,” said Søren Tulstrup, President and CEO of Santaris Pharma A/S. “This agreement further validates that Santaris Pharma’s LNA Drug Platform is the technology-of-choice for developing RNA-targeted medicines.”
The agreement includes two of Miragen’s lead programs: miR-208, which plays an important role in the pathogenesis and progression of heart failure, and miR-15/195, which plays a role in the survival and proliferative capacity of cardiomyocytes. The agreement also includes one additional cardiovascular microRNA modulator yet to be identified.
- miR-208: Miragen’s research has demonstrated that therapeutic inhibition of miR-208 may improve cardiac function and survival rates during heart failure. In addition, chemically-synthesized inhibitors of miR-208 have been shown to suppress pathological cardiac remodeling in a model of heart failure induced by chronic high blood pressure, while enhancing cardiac function and survival.
- miR-15/195: Research has shown that the inhibition of miR-15 may stimulate cardiomyogenesis, the process whereby new heart muscle cells are formed, and that inhibition of miR-15 can spare cardiomyocytes from death during myocardial infarction (MI), resulting in less heart tissue death and an improvement in cardiac function after a heart attack.
About Servier: Servier is the leading independent pharmaceutical company in France with sales worldwide reaching EUR3.7 billion in 2010. Servier is established in 140 countries with its main therapeutic products treating cardiovascular diseases, diabetes, CNS disorders, oncology and rheumatological diseases. More than 25 percent of Servier’s turnover is invested in research and development. Servier has more than 20,000 employees worldwide, including nearly 3,000 in R&D. For more information, please visit www.servier.com.
About Miragen Therapeutics: Miragen Therapeutics, Inc., was founded in 2007 to develop innovative microRNA-based therapeutics for cardiovascular and muscle disease. Only recently discovered, microRNAs are short, single-stranded RNA molecules encoded in the genome that regulate gene expression and play a vital role in influencing cardiovascular and muscle disease. Cardiovascular disease is the leading cause of death globally and represents an enormous burden on global healthcare systems. Principally funded through venture capital investments, miRagen combines world recognized leadership in cardiovascular medicine with unprecedented in-house expertise in microRNA biology and chemistry. For more information, please visit www.miragentherapeutics.com.
About microRNAs: MicroRNAs have emerged as an important class of small RNAs encoded in the genome. They act to control the expression of sets of genes and entire pathways and are thus thought of as master regulators of gene expression. Recent studies have demonstrated that microRNAs are associated with many disease processes. Because they are single molecular entities that dictate the expression of fundamental regulatory pathways, microRNAs represent potential drug targets for controlling many biologic and disease processes.
About Santaris Pharma A/S’ Locked Nucleic Acid (LNA) Drug Platform: The LNA Drug Platform developed by Santaris Pharma A/S leverages the Company’s proprietary LNA chemistry to rapidly deliver LNA-based drug candidates against RNA targets, both mRNA and microRNA, for a range of diseases. LNA-based drugs are a promising new class of therapeutics that are enabling scientists to develop drug candidates to work through previously inaccessible clinical pathways. The unique combination of small size and very high affinity allows this new class of drugs candidates to potently and specifically inhibit RNA targets in many different tissues without the need for complex delivery vehicles.