Isis cholesterol drug hits bulls-eye in pivotal trial

Isis Pharmaceuticals (ISIS) says that its experimental cholesterol drug mipomersen hit its primary endpoint in a late-stage trial, cutting levels of LDL by an average of 25 percent among patients genetically inclined to develop high cholesterol. And some patients demonstrated a reduction of 70 to 80 percent. Average LDL levels in study patients--who inherit the condition from both parents--are over 400 while guidelines call for a level under 100. The drug is given by injection once a week. Another late-stage trial examines the effect of the drug among patients who inherit the condition from one parent.

Isis' marketing partner Genzyme [1] is expected to file for U.S. and European regulatory approval of mipomersen by the middle of 2011. Investors, though, were spooked to see that Isis plans to file for approval a year later than expected. And Isis shares plunged 15 percent.

"If it works in this condition, which is a very difficult condition to treat, it's going to work a hell of a lot better in patients with regular (high cholesterol)," says lead investigator Frederick Raal.

- check out Isis' release [2]
- here's the story [3] from Reuters

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Isis spin-off gets a fresh injection of venture funds [5]
Genzyme: Phase III mipomersen a success [6]
Genzyme and Isis - Top 10 deals of 2008 [1]