Regulus Enters Into New Collaboration Agreement with Biogen Idec to Identify microRNA Biomarkers in Multiple Sclerosis - Applied Clinical Trials

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Regulus Enters Into New Collaboration Agreement with Biogen Idec to Identify microRNA Biomarkers in Multiple Sclerosis - New Research to Profile Whole Blood Samples of Patients Treated with a Biogen MS Therapy - - Regulus to Receive $2M Upfront with Potential Future Milestone Payments -


Regulus Enters Into New Collaboration Agreement with Biogen Idec to Identify microRNA Biomarkers in Multiple Sclerosis

- New Research to Profile Whole Blood Samples of Patients Treated with a Biogen MS Therapy -

- Regulus to Receive $2M Upfront with Potential Future Milestone Payments -

PR Newswire

LA JOLLA, Calif., Aug. 5, 2014 /PRNewswire/ -- Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that it has entered into a new collaboration agreement with Biogen Idec (NASDAQ: BIIB) to expand its research focused on identifying microRNAs as biomarkers for multiple sclerosis (MS) under its Regulus microMarkers™ division.  The new research will focus on profiling a large number of whole blood samples from a cohort of MS patients who have been treated with a Biogen Idec MS therapy to identify potential microRNA signatures.  Regulus will receive $2M upfront and is eligible for future payments upon achievement of certain milestones related to the identification of potential microRNA signatures.

Regulus and Biogen Idec began their collaboration in August 2012 to identify potential microRNA biomarkers in MS.  Regulus used its highly reproducible, proprietary technology platform to extract, profile, and analyze microRNAs from small volumes of blood (plasma, serum or whole blood) to profile over 400 serum samples from MS patients and compare those profiles against the profiles of healthy volunteers.  The results of these experiments helped define the scope of the research under the new collaboration agreement, which resulted in a termination of the August 2012 agreement.   

"We are pleased to grow the Regulus microMarkers division and expand our research on microRNA biomarkers with Biogen Idec," said David L. Szekeres, Chief Business Officer and General Counsel of Regulus. "Our collaboration has made significant progress to date and we are hopeful to continue to help advance Biogen Idec's leading multiple sclerosis franchise in a meaningful way with our innovative technology platform."

About microRNAs and microRNAs as Biomarkers

The discovery of microRNAs in humans during the last decade is one of the most exciting scientific breakthroughs in recent history.  microRNAs are small RNA molecules, typically 20 to 25 nucleotides in length, that do not encode proteins but instead regulate gene expression. More than 800 microRNAs have been identified in the human genome, and over one-third of all human genes are believed to be regulated by microRNAs.  A single microRNA can regulate entire networks of genes. As such, these molecules are considered master regulators of the human genome.  microRNA expression, or function, has been shown to be significantly altered or dysregulated in many disease states, including oncology, fibrosis, metabolic diseases, immune-inflammatory diseases and HCV. 

In addition to being clinically relevant therapeutic targets, microRNAs may be ideally suited as biomarkers for multiple diseases.  microRNAs have been detected in bodily fluids such as blood, and emerging data has demonstrated that microRNA signatures in blood can mimic the expression profile observed in disease tissues.  Regulus believes that microRNA biomarkers are of significant value and may be used to select optimal patient segments in clinical trials and to monitor disease progression or relapse.  

About Regulus micro Markers™

In January 2014, Regulus established a new division, RegulusmicroMarkers™, to support the expansion of its innovative biomarkers platform which is utilized for its therapeutic pipeline, collaborators' and strategic partners' programs. RegulusmicroMarkers™ utilizes a highly reproducible, proprietary technology platform to extract, profile, and analyze microRNAs from small volumes of blood (plasma, serum or whole blood) to differentiate disease from healthy patient samples and to identify microRNAs as potential biomarkers for disease. Regulus has profiled approximately 3,000 clinical samples in a wide variety of disease states including multiple sclerosis, chronic kidney disease, fatty liver, rheumatoid arthritis and others. In August 2012, Regulus formed a research collaboration with Biogen Idec focused on the discovery of microRNAs as biomarkers for MS.  Regulus has also entered into an arrangement with another leading, commercial-stage pharmaceutical company to explore microRNAs as biomarkers for specific patient populations. Additionally, Regulus maintains several academic research collaborations focused on the identification of microRNAs as biomarkers in multiple disease areas.

About Regulus Therapeutics Inc.

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is uniquely positioned to leverage a mature therapeutic platform that harnesses the oligonucleotide drug discovery and development expertise of Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc., which founded the company.   Regulus has a well-balanced microRNA therapeutics pipeline entering clinical development, an emerging microRNA biomarkers platform to support its therapeutic programs, and a rich intellectual property estate to retain its leadership in the microRNA field.  Regulus intends to focus its proprietary efforts on developing microRNA therapeutics for oncology indications and orphan diseases and is currently advancing several programs toward clinical development in oncology, fibrosis and metabolic diseases.  Specifically, Regulus is developing RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy, and RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection.  Regulus' commitment to innovation and its leadership in the microRNA field have enabled the formation of strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec focused on microRNA biomarkers.  In addition, the Company has established Regulus microMarkers™, a division focused on identifying microRNAs as biomarkers of human disease, which is designed to support its therapeutic pipeline, collaborators and strategic partners. 

For more information, please visit http://www.regulusrx.com

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with financial estimates (including Regulus' projected cash at the end of 2014), the projected sufficiency of Regulus' capital position for future periods, the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to development and other activities related to RG-012 and RG-101 and with respect to the nomination of a third microRNA candidate for clinical development), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus' business plans, technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by Regulus.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential," "hopes" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  These and other risks concerning Regulus' financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

SOURCE Regulus Therapeutics Inc.

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