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 an agreement for advancing the research, development and commercialization of three drug candidates, including two of miRagen’s lead programmes (miR-208 and miR-15/195) and one additional target yet to be identified, for cardiovascular disease.  This partnership provides worldwide rights, excluding the US 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 US and Japanese markets.  Miragen retains all rights in the US 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 US 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 programmes 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.

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.  

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.