Isis, Genzyme upbeat on PhIII mipomersen data

Isis (NASDAQ: ISIS) and Genzyme (NASDAQ: GENZ) have hit a slate of primary and secondary Phase III targets for their closely watched cholesterol drug mipomersen, putting them on track to file an NDA in the first half of 2011.  Despite the upbeat news, Isis shares slid about 8 percent this morning. Investigators recruited more than 200 hard-to-treat patients for the late-stage trials. And they say that liver enzyme levels, a key safety biomarker, were comparable to earlier studies. In...

Isis, Genzyme brace for new round of late-stage cholesterol data

Can Isis Pharmaceuticals' persuade the FDA that a spike in some liver enzyme readouts for patients in late-stage trials of its cholesterol drug mipomersen is a normal phenomenon that shouldn't prohibit approval of the therapy? Reuters takes a close look at the drug, which was partnered with Genzyme in a rich, $325 million pact, and offers Isis (ISIS) plenty of space to make its case. As the wire service relates, Isis is expected to deliver a barrage of pivotal data on mipomersen from...