Date: 2017-05-03
Type of information: R&D agreement
Compound: three drug candidates, including two of miRagen’s lead programs (miR-208 and miR-15/195), one additional target , MicroRNA-92 and MRG-110
Company: Servier (France) Miragen Therapeutics (USA -CO)
Therapeutic area: Cardiovascular diseases
Type agreement: R&D
commercialisation
Action mechanism: MRG-110, the lead product candidate under the collaboration, inhibits the activity of microRNA-92, which has been shown to be a regulator of new blood vessel creation in multiple peer reviewed scientific publications. This may indicate that MRG-110 could be useful in the treatment of ischemic disease, cardiovascular disease and certain other vascular flow related diseases.
Disease: cardiovascular diseases
Details:
- • On October 18, 2011, Servier and Miragen Therapeutics have announced 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. 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.
Financial terms:
- 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.
Latest news:
- • On May 3, 2017, Servier and Miragen Therapeutics announced that they have extended their research collaboration through September 2019. MicroRNA-92 has been added to the existing collaboration as a new therapeutic target, with the objective to start testing MRG-110 in humans within a year. Servier is responsible for leading the global clinical development and potential commercialization of MRG-110, and any other microRNA therapeutic product candidates developed through the collaboration in all countries except the United States and Japan, where miRagen retains all rights. miRagen has the right to utilize Servier generated data for regulatory filings in the United States and Japan. In conjunction with the amendment, Servier has returned to miRagen the rights to certain other preclinical programs. Servier has the option to add one additional microRNA target for research and development in cardiovascular disease under this collaboration through September 2019.
- • On June 23, 2014, Servier and miRagen Therapeutics announced that they have extended their research collaboration by two years to October 2016 to discover, develop, and commercialize drugs targeting microRNAs for cardiovascular disease. miRagen and Servier Research will continue preclinical research and development on multiple cardiovascular programs targeting microRNAs, including miR-208 and miR-15. Servier will lead the global clinical development and commercialization of microRNA therapeutic product candidates developed through the collaboration in all countries except the U.S. and Japan, where miRagen has retained all rights. The collaboration initially included two named targets (miR-208 and miR-15/195) and in May 2013 Servier exercised an option to include an additional undisclosed target to the collaboration. Under the terms of the agreement, miRagen received an upfront payment in 2011 and an additional payment when Servier expanded the agreement to cover the additional target in 2013. miRagen may also receive additional research and development milestone payments, commercial milestone payments and royalties on the sale of products developed under the collaboration. Servier will continue to finance the research, development, regulatory approval, and commercialization costs of product candidates under the collaboration. miRagen retains all commercialization rights in the U.S. and Japan, and the option to co-sponsor any Phase III programs if miRagen elects to seek marketing approval in the U.S. or Japan for any product developed under the collaboration.
- • On May 23, 2013, Servier and miRagen Therapeutics have announced that Servier has elected to add a new target as part of its existing agreement for advancing the research, development and commercialization of microRNA-based drug candidates for the treatment of cardiovascular disease. With this selection, Servier and miRagen now have three microRNA programs under development. The Servier Alliance initially included two named targets (miR-208 and miR-15/195) and granted Servier the right to add one additional target. In May 2013, Servier elected to add a third, undisclosed, target. Under the terms of the agreement, miRagen received an upfront payment in 2011, is scheduled to receive a target selection payment in 2013, and additional research and development milestones per target
Is general: Yes
