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Re: DewDiligence post# 163451

Wednesday, 07/03/2013 1:14:53 PM

Wednesday, July 03, 2013 1:14:53 PM

Post# of 257580
(JNJ)—PTLA does not have the only FXa-antidote; in this trial, JNJ used prothrombin complex concentrates (a standard product from plasma-collection companies) to reverse the effect of Xarelto:

http://finance.yahoo.com/news/prothrombin-complex-concentrates-reverse-blood-070000363.html

The study, presented today as an oral session at the International Society on Thrombosis and Haemostasis Annual Meeting in the Netherlands, evaluated three- and four-factor PCCs in 34 healthy adults treated with 20 mg of XARELTO. Participants were treated with XARELTO twice a day for four days. On the fifth day, participants received either a 50 IU/kg single bolus dose – quickly administered intravenously – of three-factor PCC (Profilnine SD), a four-factor PCC (Beriplex P/N), or a 100 mL single bolus dose of saline as a control.

Both three- and four-factor PCCs were found to partially reverse the XARELTO®-induced prolongation of the prothrombin time (PT) – the time it takes the blood to clot – in healthy subjects, with the latter reducing the mean PT by 2.5 to 3.5 seconds (versus a 0.6 to 1.0 second reduction associated with three-factor PCC). Conversely, three-factor PCC had a greater effect on the reversal of XARELTO®-induced changes in endogenous thrombin potential (ETP) – the total amount of thrombin generated during the test – than four-factor PCC.

Based on my interpretatin of this PR and the one from PTLA in the preceding post (#msg-89623120), PCCs are not quite as effective as PTLA's PRT-4445.

Perhaps JNJ is running the study of PCCs to increase its negotiating leverage with PTLA for a PRT-4445 development deal.

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