Replies to post #80189 on Biotech Values

[acgood]

yes, but shouldn't these benefits of M118 translate into measurable clinical improvement vs the existing "flawed" anticoagulants in this patient population?

[alertmeipp]

Looks like the result was leaked a few days ago...good stuff anyways.

[DewDiligence]

MNTA – Correction to #msg-39146357 re Xarelto:

The footnote at the very bottom of #msg- said: “Xarelto is not included in the table above because it is not yet approved.” Actually, it would be more accurate to say that MNTA did not include Xarelto (a/k/a/ rivaroxaban) in the table of M118 comparator drugs because, to date, there are no phase-3 data for Xarelto in the ACS indication. Rather, Xarelto’s approval in the EU and its pending NDA in the US are for VTE prevention.

Xarelto does have phase-2 data in ACS, as described in a Nov 2008 PR from JNJ (#msg-33517140):

“Safety was evaluated by measuring clinically significant bleeding, defined as a composite of TIMI major bleeding, TIMI minor bleeding and any reported bleeding event requiring medical attention. As expected, rivaroxaban-treated patients exhibited higher rates of bleeding versus placebo when administered on a background of antiplatelet therapy, and there was a significant dose trend (p<0.001)… Rates of clinically significant bleeding were [all doses BID]:

placebo: 3.3%;
rivaroxaban 5 mg: 6.1%;
rivaroxaban 10 mg: 10.9%;
rivaroxaban 15 mg: 12.7%;
rivaroxaban 20 mg: 15.3%.”

In phase-3, the doses being tested are 2.5mg and 5mg (BID) (http://clinicaltrials.gov/ct2/show/NCT00809965 ). In other words, the lowest dose being tested in phase-3 is half the lowest dose that was tested in phase-2 due to the bleeding risk.

All told, I think it’s fair to say that Xarelto has its work cut out for it in the ACS indication.