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Getting to the heart of the matter
December 2011
by Kelsey Kaustinen  |  Email the author


SURESNES, France—The pulse is picking up in the field of cardiovascular disease treatment, as Les Laboratoires Servier and miRagen Therapeutics Inc. have established a new agreement for the research, development and commercialization of three drug candidates for cardiovascular disease, including miR-208 and miR-15/195, miRagen's lead programs, and one yet-to-be- identified additional target.  
Under the agreement, Servier will pay miRagen up to $45 million up front, research support and near-term milestone payments over the next three years and sales royalties based on the successful outcome of the partnership. Adding in clinical and commercial milestones and clinical development support for the compounds' successful development, the deal could have a total value of approximately $1 billion.  
Servier and miRagen will collaborate on the research and development efforts up to the point of IND filing, after which Servier will be responsible for all costs associated with global development, regulatory approval and commercialization of the three product candidates worldwide, with the exception of the U.S. and Japanese markets. miRagen will retain all rights in those two markets, and will have the option to co-sponsor any Phase III programs should miRagen, alone or with a partner, decide to seek marketing approvals for any of the targets in the United States 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," Dr. Emmanuel Canet, head of Servier R&D, said in a press release.
miR-208 has been shown to play an important role in the pathogenesis and progression of heart failure, and inhibition of miR-208 has the potential to improve cardiac function and survival rates during heart failure. miR-15/195 plays a role in the survival and capacity for proliferation of cardiomyocytes, and inhibiting it could stimulate cardiomyogenesis, or the formation of new heart muscle cells. Inhibiting miR-15 and sparing cardiomyocytes from death during myocardial infarction could lead to less heart tissue death and improved cardiac function following a heart attack.  
As for the third target, Dr. William S. Marshall, president and CEO of miRagen, says it could be defined in one of two ways, noting it will either be something in the earlier stages of development within miRagen's pipeline, or something from the broad-based discovery program miRagen and Servier have for new microRNAs.  
Servier represented an appealing partner, Marshall says, given its "strong commitment and development of cardiovascular drugs" and expertise in terms of clinical "capabilities and logistics to conduct global, large-scale clinical trials in this area."
"They were a partner that demonstrated all these attributes of long-term commitment and vision," says Marshall. "It also was a near-immediate sense of a shared vision … there was an excitement demonstrated by their research teams, their development team, that really sort of synced up well with the way that the miRagen staff felt about these programs."
Pascal Touchon, director of scientific cooperation and business development at Servier, echoes the sentiment, adding that miRagen's approach represents "truly innovative ways to address the current medical need in cardiovascular diseases."  
"From the first meetings between scientists from both companies, I could feel respect, common understanding on key issues and the desire to collaborate together for the benefit of patients," says Touchon. "We clearly saw as well the scientific and professional approach of miRagen towards product discovery and development. Also worth mentioning is the fact that they had obtained clear access through licenses to the necessary technologies from universities and Santaris."  
miRagen's lead programs both make use of Santaris Pharma's Locked Nucleic Acid (LNA) Drug Platform, which miRagen licensed the rights to in June 2010 in order to identify drug candidates against its proprietary microRNA targets for the treatment of cardiovascular disease. The agreement has been expand to allow miRagen to develop additional targets and to grant Server access to the LNA technology.  
Marshall notes that there is no lack of commercial potential for these programs, as "the latest statistics would indicate that the healthcare costs associated with chronic heart failure are $30 billion to $40 billion a year," with a five-year mortality rate of about 50 percent. Current therapies are all palliative, he adds, and there is a decided lack of disease-modifying therapies available.
"We believe that because the unique aspects of microRNA biology mean that we affect biological networks, that we will be able to identify disease-modifying therapies," says Marshall, "and all of the preclinical efficacy data thus far would support the notion that we've got something that's really game-changing."

Servier and Prognomix in type 2 diabetes deal  
SURESNES, France—Les Laboratoires Servier of France also announced last month that it has entered into a research and development agreement with Prognomix Inc. aimed at identifying novel targets for type 2 diabetes and metabolic disease treatment.    
Prognomix is a Montreal-based, privately held personalized medicine company that is focused on discovery and clinical application of genomic signatures predictive of susceptibility to diseases, their complications and individual therapeutic responsiveness. The company has made significant progress in the identification of the genomic features associated with complications of type 2 diabetes. Based on these findings, Prognomix has developed a prototype of a molecular diagnostic kit that will include clinical, genomic and epigenomic markers.
The companies' collaboration will rest on Prognomix 's discovery platform comprising genomic and bioinformatics technologies, a database of phenotypic and genotypic data and an assembly of results of the analysis of these data. The knowledge base they explore was developed using the data collected during ADVANCE, the largest clinical study ever conducted on type 2 diabetes and of which Servier was the main sponsor.
Financial terms of the agreement were not released. As part of the agreement, Servier will make a contract signature fee payment and will be granted options to obtain rights to use the results of the collaboration.
Code: E121103



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