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Isis Reports Strong Financial Results and Highlights for First Quarter of 2009
Date:5/7/2009

Isis' cardiovascular pipeline, is being evaluated in a broad Phase 3 program in patients who cannot adequately control their cholesterol levels with current therapies and who need new treatment options.

  • Isis and Genzyme initiated a Phase 3 study evaluating mipomersen in severe hypercholesterolemia patients. This latest mipomersen study is the fourth new clinical study initiated by Isis and Genzyme since the formation of the collaboration in early 2008.
  • The regulatory strategy for European approval of mipomersen continues to evolve. Genzyme is planning an initial European submission for homozygous Familial Hypercholesterolemia (FH) with timing expected to be similar to that of the United States homozygous FH submission anticipated in the second half of 2010. Data from the severe hypercholesterolemia trial should be available at the time of this submission and may be basis for a broader indication. A potential second filing in Europe for patients with heterozygous FH could take place as early as late 2012. Genzyme will await data from an outcomes study prior to making additional submissions to potentially expand mipomersen's indication.

Isis' internal and partnered pipeline continues to mature as drugs in the pipeline advance in clinical development.

  • Isis initiated a Phase 1 clinical study of ISIS-SGLT2Rx for the treatment of type 2 diabetes in healthy volunteers.
  • Investigators participating in a Phase 1 study of iCo-007 presented data from an interim analysis of the study that showed iCo-007 appears to be well tolerated and demonstrates promising signs of activity in patients with diffuse diabetic macular edema.
  • OncoGenex reached an agreement with the FDA on the design of a second Phase 3 registration trial of OGX-011 that features durable pain palliation as the primary endpoint in
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SOURCE Isis Pharmaceuticals, Inc.
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