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Replies to #78303 on Biotech Values
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genisi

05/22/09 2:39 PM

#78384 RE: apljack #78303

ISIS/GENZ: Mipomersen

I would note that a rapid, severe reductions in ApoB is expected to result in liver enzymes elevation however, the patient in phase III trial (as in previous studies), did not have an elevation in bilirubin. Think this will be acceptable in subjects with homozygous familial hypercholesterolemia (HoFH). Approval of mipomersen beyond HoFH, in broader high-risk populations requires an outcomes study, that should begin mid 2010. Suppose ISIS/GENZ are waiting for data (expected end of 2009/early 2010) from ongoing mipomersen studies in high-risk high-cholesterol patients (HeFH, apheresis, polygenic), to get a better view on its risk/reward and future development.