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Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009
Date:8/6/2009

Excluding non-cash compensation expense related to stock options, operating expenses for Regulus were $2.7 million and $5.5 million for the three and six months ended June 30, 2009 compared to $1.7 million and $2.8 million for the same periods in 2008. The increase is primarily related to Regulus' continued efforts to build its team to support its internal microRNA programs and its GSK collaboration. Regulus generated a loss from operations, excluding non-cash compensation expense related to stock options, of $1.6 million and $3.8 million for the three and six months ended June 30, 2009 compared to $1.1 million and $2.1 million for the same periods in 2008.

Business Highlights

"During the last quarter, we and Genzyme made great progress regarding mipomersen on two important fronts, advancing the clinical development program and refining our regulatory strategy. We reported positive top-line results from a Phase 3 study of mipomersen in the largest, placebo-controlled Phase 3 study in homozygous FH patients. We reported that the study met its primary endpoint with a 25% reduction in LDL-C after 26 weeks of treatment with mipomersen versus 3% for placebo and all of its secondary endpoints in a highly statistically significant manner. We are very pleased with the performance of mipomersen in this study. These data are a significant milestone in the clinical development of mipomersen and support our efforts to make the drug available to patients in need," said Ms. Parshall.

"In addition to reporting data from the first of our Phase 3 trials for mipomersen, we and Genzyme refined and communicated the regulatory path for mipomersen in the United States and Europe. While the strategy continues to evolve, Genzyme plans to file the first NDA for mipomersen in the U.S. for homozygous FH in the second half of 2010, with a similar filing in Europe shortly afterwards. Data from our Phase 3 study in
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SOURCE Isis Pharmaceuticals, Inc.
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