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Biotech / Medical : Biotech success, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (104)	10/29/2002 6:44:47 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 117

Old: <<The proximal VTE/PE rate was 3.3 percent for ximelagatran and 5.0 percent for warfarin. >> non-significance??? (it is 34% reduction) and new: <<WILMINGTON, Del., Oct. 28 /PRNewswire-FirstCall/ -- Results of a Phase III clinical trial of AstraZeneca's investigational oral anticoagulant EXANTA(TM) (ximelagatran) showed that treatment with EXANTA significantly reduced by 63 percent the risk of proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) after orthopedic surgery compared with the low-molecular-weight heparin, enoxaparin (2.3 percent vs 6.3 percent, p=0.0000018). >> So, by ~1% they have reduction in active drug group while in warfarin/LMWH they have ~1% increase. On the other hand relative risk was almost equal (~26%) for both trial: 1. "Warfarin can prevent DTE if it is tightly controlled and carefully monitored. That is exactly what happened in this study. In the warfarin arm the VTE rate was 25.7 percent, which is much, much better than the 40 percent to 45 percent rate in other warfarin trials." 2. “EXPRESS also showed a 23.6 percent reduction in the risk of total DVT/PE following preventative treatment (thromboprophylaxis) with EXANTA, compared with enoxaparin (20.3 percent vs. 26.6 percent, p=0.0003).” Bottom line, they have reduced bars for significance(???), IMO. It is not that warfarin/LMWH responder was to high in first US trial, only that in EU trial they have better result for ximelagatran. They are repeating US trial, and this will be final answer about superiority. Target is 20-25% reduction in relative risk with (I think about 40-50%) reduction in proximal DVT/PE. BTW, Lovenox sale did not grow this year as Aventis expected, change in label.