Replies to post #117898 on Biotech Values

[DewDiligence]

Lovenox-vs-Apixaban—These kinds of head-to-head trials are clumsy insofar as one drug (Apixaban) is given for 30 days while the other (Lovenox) is given for only 1-2 weeks. The difference in duration of treatment makes it more difficult to assess the relative merits of the two drugs.

[dewophile]

We're yet to see if Apixaban can produce a better profile (I think it has a better shot) in this indication from this study

i think it has a better shot as well, but i still view it as a fairly high risk study given apixaban did show more bleeding than placebo in the ACS trial, so they likely are going to have to show a real efficacy benefit to justify what is likely going to be a slightly higher bleeding rate vs those who jsut take placebo after discharge from the hospital
in terms of data flow i assume ARISTOTLE will be in before this reads out, which imo is more likely to be successful - so success in this indication would be the cherry on top

[DewDiligence]

Confirmed on 4Q11 JNJ CC—Xarelto is no-go for VTE prevention in immobilized patients:

http://seekingalpha.com/article/321705-johnson-johnson-s-ceo-discusses-q4-2011-results-earnings-call-transcript

…after further consultation with the FDA, we have decided not to file an sNDA for the use of XARELTO in the medically ill population at this time, based on the results of the Magellan trial.

The at this time qualifier is, of course, perfunctory. This indication for Xarelto has effectively been dead for almost a year (#msg-61803303).

p.s. The analysis in paragraph B of #msg-69173426 assumes that the new oral anticoagulants make no headway against Lovenox in this indication.