PLX - Completion of enrollment in the ph.III trial expected around mid-year and data is expected 1Q09.
Shire recently announced plans to submit an NDA for GA-GCB in 2H09 and expects to launch the agent in 2010, so there's no setback.
Zavesca is currently used primarily in patients unable to receive Cerezyme. It has lower efficacy than Cerezyme and a high rate of GI side effects, so it is not an important competitive threat.
Genzyme is developing a small molecule substrate inhibitor, Genz-112638, in phase II that is a lot more potent than Zavesca but I suppose it will have more serious AE.
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