Replies to post #169754 on Biotech Values

[DewDiligence]

PTLA—Inasmuch as PRT4445 was able to inhibit Eliquis (#msg-87707322), it would have been very surprising if it didn’t also inhibit Xarelto, since Eliquis and Xarelto work exactly the same way.

PRT4445 still has a long way to go, and (as noted in #msg-91053501) I’m skeptical that the FDA will approve it based on only phase-2 PoC studies and a single PD study, as PTLA contends.

[DewDiligence]

B-I presents phase-1 data on Pradaxa antidote at AHA:

http://in.reuters.com/article/2013/11/18/us-pradaxa-antidote-idINBRE9AH0O820131118

…researchers on Monday said data from a Phase 1 study of Pradaxa involving almost 150 healthy volunteers suggest a safe and effective antidote to Pradaxa may be within reach in coming years. The antidote is a fragment of a monoclonal antibody…

…Volunteers received the antidote through 5-minute intravenous infusions after taking Pradaxa for four days. "At the end of the infusion we observed an immediate and complete reversal" of Pradaxa in terms of the drug's anti-coagulation effect, Boehringer's Glund said…. Moreover, he said no serious side effects were seen with the antidote. "It has a very positive safety profile."

Pradaxa cannot be reversed by PTLA’s PRT4445 because (unlike Xarelto, Eliquis, Edoxaban, and Betrixaban) Pradaxa is not a Factor Xa inhibitor.

[DewDiligence]

PTLA reports more phase-2 data on PRT4445 for Xarelto reversal:

http://finance.yahoo.com/news/portola-pharmaceuticals-announces-phase-2-160000774.html

CC from ASH going on right now.