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Regulus Therapeutics, GlaxoSmithKline, Rosetta Genomics, University of California, Irvine, Isis Pharmaceuticals, Marligen Biosciences, Genisphere

Regulus, GlaxoSmithKline Strike microRNA Drug Alliance
Regulus Therapeutics and GlaxoSmithKline announced this week that they have formed a worldwide strategic alliance to discover, develop, and market microRNA-based therapeutics for inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease.
Under the deal, GlaxoSmithKline will have an option to license product candidates directed at four different microRNA targets related to inflammatory disease. In exchange, Regulus will receive $20 million upfront from GlaxoSmithKline, which includes a $15 million option fee and a $5 million note that will convert into Regulus stock in the future under certain undisclosed circumstances.
Regulus could also receive up to $144.5 million in development, regulatory, and sales milestones, as well as tiered royalties up to double-digit percentages on the sale of products resulting from the alliance.
Regulus, a joint venture between Alnylam Pharmaceuticals and Isis Pharmaceuticals (see RNAi News, 9/13/2007), will be responsible for the discovery and development of the microRNA antagonists through completion of clinical proof of concept, unless GSK chooses to exercise its option earlier, according to the companies.
“After exercise of the option, GSK will have an exclusive license to drugs developed under each program by Regulus for the relevant microRNA target for further development and commercialization on a worldwide basis,” the companies added. “Regulus will have the right to further develop and commercialize any microRNA therapeutics which GSK chooses not to develop or commercialize.”
Additional terms were not disclosed.

Rosetta, UC Irvine to Collaborate on miRNA Diagnostics
Rosetta Genomics said this week that it has struck an agreement to collaborate with the University of California, Irvine, School of Medicine to validate diagnostic tests based on the company’s microRNA technology.
Under the agreement, the CLIA-certified medical school and the company will work together to validate tests that are designed to differentiate squamous from non-squamous non-small cell lung cancer and to differentiate mesothelioma from adenocarcinoma, as well as to identify cancers of unknown primary origin.
Rosetta Genomics currently expects to launch three microRNA diagnostic tests in clinical laboratories sometime this year. The first test, for differentiating non-small cell lung cancer, was submitted for approval by the New York State Department of Health earlier this month (see RNAi News, 4/10/2008). It will be commercialized by Columbia University Medical Center, another Rosetta collaborator.

Isis Reports Positive Results from Open-Label Study of Cholesterol Drug
Isis Pharmaceuticals this week reported that additional data from an ongoing phase II open-label extension trial has shown its flagship cholesterol drug candidate mipomersen is well-tolerated and maintains activity out to 16 months.
Patients with familial hypercholesterolemia who were originally enrolled in one of two other clinical studies of the drug were allowed to enter the extension trial, Isis said.
“Most patients received 200 mg [per] week of mipomersen in addition to maximum-tolerated lipid-lowering therapy,” the company added. “The median duration of continuous exposure in these patients was 38 weeks [and] the maximum continuous exposure was 64 weeks.”
The drug was well tolerated in longer-term treatment, Isis noted, and there were no new types of adverse events observed and the rates of adverse events decreased during the extension study from those in the initial efficacy studies.

Marligen to Distribute Genisphere's Labeling Kits for miRNA Detection
Marligen Biosciences said last week that it has signed an exclusive agreement to distribute Genisphere’s labeling kits for detection of microRNAs on Luminex’s xMAP multiplex platform.
Marligen plans to distribute Genisphere’s kits along with its Vantage product line, which includes kits for purifying, labeling, and detecting microRNA species. Marligen said the complete system offers throughput capabilities of over 100 samples a day and it is compatible with total RNA or enriched RNA including degraded RNA from archived tissues.
The Vantage microRNA panels were designed to profile various microRNAs that are relevant in oncology.
The agreement “will not only advance basic research but should expedite the application of microRNA detection in the diagnosis of cancer,” Marligen Biosciences CSO James Lazar said in a statement. 
Financial terms of the agreement were not released.