miragen

miRagen SERVIER agreement

  • 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 [click to continue…]

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Industry Press Update

by Chris on February 17, 2011

in Press Release

02/17/2011 – 09:00 AM
miRagen Therapeutics Receives Orphan Drug Designation for MGN-4893 for the Treatment of Polycythemia Vera

02/10/2011 – 04:00 PM
Alnylam to Webcast Conference Call Discussing Fourth Quarter and 2010 Financial Results

02/10/2011 – 08:30 AM
Regulus Therapeutics to Present Multiple Platform and Pipeline Advancements at the Keystone Symposium on microRNAs

02/08/2011 – 04:00 PM
Alnylam to Webcast Presentation at the 13th Annual BIO CEO & Investor Conference

01/27/2011 – 07:15 AM
RXi Pharmaceuticals Announces Positive Initial Results in microRNA Therapeutics

01/25/2011 – 08:00 AM
Alnylam Receives Positive Opinion for Orphan Drug Designation from European Medicines Agency for ALN-TTR01, an RNAi Therapeutic for the Treatment of Transthyretin-Mediated Amyloidosis

01/25/2011 – 07:30 AM
NanoString Technologies Introduces Multiplexed Assay Kit for Mouse microRNA Analysis

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WORCESTER, Mass.–(BUSINESS WIRE)–RXi Pharmaceuticals Corporation (Nasdaq: RXII), a recognized leader in RNAi-based therapeutics, announced today that, as part of its collaboration with miRagen Therapeutics, Inc., positive data were generated demonstrating that RXi’s sd-rxRNA™ technology can be used, in vitro, to specifically enhance the activity of a microRNA of high interest to miRagen.

The parties have successfully applied RXi’s proprietary sd-rxRNA (self-delivering rxRNA) technology to create microRNA mimics, or artificial copies of microRNAs. In particular, they have demonstrated efficacy in down-regulating a reporter gene whose expression is controlled by the microRNA in cell culture model systems developed by miRagen. Increasing the level of particular microRNAs by using therapeutic mimics may treat certain diseases, including cardiovascular, cancer, inflammatory, fibrotic and metabolic disorders. This data will be presented in a poster at the upcoming Keystone Symposia’s MicroRNAs and Non-Coding RNAs and Cancer meeting February 11-16, 2011 and will be available on RXi’s website after the conference www.rxipharma.com.

(read the entire release… )

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BOULDER, Colo.–(BUSINESS WIRE)–miRagen Therapeutics, Inc., a biopharmaceutical company focused on improving patients’ lives by developing innovative microRNA (miRNA)-based therapeutics for cardiovascular and muscle disease, announced today that it is the recipient of the University of Colorado (CU) Technology Transfer Office Bioscience Company of the Year award. The award will be conferred this evening at the CU Technology Transfer Annual Awards Banquet in Denver.

“We are honored to be recognized by the University of Colorado with this award, and pleased to be working with them on the Beta Blocker Effects on Remodeling and Gene Expression (BORG) study”

miRagen Therapeutics and CU signed research and licensing agreements in October 2010 launching their collaboration on microRNA therapeutics discovery and development. The collaboration is focused on microRNA profiling of a human heart failure study conducted at CU.

(read the entire release… )

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Recent Industry Press

by Chris on October 14, 2010

in Press Release

10/14/2010 – Mirna Therapeutics Announces Dr. David Johnson as Scientific Advisor

AUSTIN, Texas–(BUSINESS WIRE)–Mirna Therapeutics, Inc. (“Mirna”) announced today that David Johnson, M.D., F.A.C.P., of UT Southwestern in Dallas, has joined the Company as Scientific Advisor.

Dr. David Johnson recently moved from Vanderbilt University in Nashville, Tennessee, to take the helm as the Donald W. Seldin Distinguished Chair in Internal Medicine, and Chairman of the Department of Internal Medicine at the UT Southwestern Medical School in Dallas, Texas. Dr. Johnson is the recipient of numerous honors and awards and served on the Board of Directors of several key institutions and associations, including the American Society of Clinical Oncology (ASCO), the American Board of Internal Medicine, and the National Comprehensive Cancer Network (NCCN). (read the entire release… )

10/08/2010 – Alnylam Scientists Present New Research on Expanded Delivery of RNAi Therapeutics

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company presented new pre-clinical research today at the 8th International M. Judah Folkman Conference, New Frontiers in Therapeutic Development, held October 8-9, 2010 in Cambridge, Mass, highlighting significant advances in the systemic delivery of RNAi therapeutics. The new research demonstrated effective silencing of target genes in distinct cell types and tissues beyond the liver with systemic delivery of RNAi therapeutics. In particular, novel lipid nanoparticles (LNPs) were designed in collaboration with the laboratory of Daniel Anderson, Ph.D. at the Massachusetts Institute of Technology (MIT) to deliver siRNAs to the vascular endothelium, the cells that line blood vessels throughout the body. RNAi-mediated target gene silencing was observed in endothelial cells across a broad range of tissues, with duration of action lasting for over two months after a single dose. Delivery to the vascular endothelium creates new RNAi therapeutic approaches in disease areas including atherosclerosis, diabetes, inflammation, and cancer. Additional new results were also presented regarding delivery of RNAi therapeutics to immune cells. (read the entire release… )

09/30/2010 – miRagen Therapeutics’ Director of Biology to Give Plenary Lecture at Center for Heart Failure Research Symposium in Oslo, Norway

BOULDER, Colo.–(BUSINESS WIRE)–miRagen Therapeutics, Inc., a biopharmaceutical company focused on improving patients’ lives by developing innovative microRNA (miRNA)-based therapeutics for cardiovascular and muscle disease, announced that its Director of Biology, Eva van Rooij, Ph.D., will give a plenary lecture today at the 8th Annual Center for Heart Failure Research Symposium in Oslo, Norway. Dr. van Rooij’s talk, titled “Oligonucleotide-based modulation of microRNAs to control cardiovascular disease,” will review the basis for the development of a modified short nucleic acid sequence targeting microRNA-208 (antimiR-208) as a strategy for intervention in heart disease and introduce compelling new data supporting its potential as a therapeutic agent. Data to be highlighted include antimiR-208 in hypertensive rodent models of heart failure and preliminary dose ranging and toxicology analysis in non-human primates. (read the entire release… )

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First microRNA Targeted Drug Reaches Phase II Clinical Trial

September 22, 2010

Santaris Pharma A/S announced today that it has advanced miravirsen (SPC3649), a microRNA targeted drug for treatment of  Hepatitis C virus (HCV) infection into Phase 2 studies to assess the safety and tolerability of the drug. Santaris Pharma A/S also received acceptance of its Investigational New Drug (IND) application from the U.S. Food and Drug […]

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miRagen Therapeutics Named 2009 Rising Star of the Year by Colorado BioScience Association

November 19, 2009

BOULDER, Colo.–(BUSINESS WIRE)–miRagen Therapeutics, Inc., a biopharmaceutical company focused on improving patients’ lives by developing innovative microRNA-based therapeutics for cardiovascular and muscle disease, announced today it had received the Colorado BioScience Association’s 2009 Rising Star of the Year Award. The award, which recognizes a Colorado life sciences company that has demonstrated it is “one to […]

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miRagen Looks to Oppurtunities of microRNA Therapeutics

September 15, 2009

miRNAs, which were discovered only 15 years ago, are short sequences of nucleotides that occur naturally within cells. It is estimated that there are about …(read more)

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