Replies to post #162063 on Biotech Values

[DewDiligence]

B-I files MAA to expand EU Pradaxa label to include acute treatment and secondary prevention of VTE:

http://in.reuters.com/article/2013/06/24/us-boehringer-pradaxa-idINBRE95N0K820130624

No indication that a similar application has been filed with the FDA; in the US, Pradaxa is approved only for AF/stroke prevention.

[DewDiligence]

What’s New in the Anticoagulant Arena?

[FDA issues second CRL for Xarelto in PCI sub-indication of ACS;
PTLA inks clinical-trial deal with Daiichi Sankyo for PRT-4445 +Edoxaban;
PTLA’s investment case for Betrixaban contains more than a modicum of spin;
B-I submits Pradaxa MAA for acute treatment/secondary prevention of VTE.]


General information
#msg-51227061 How large is the anticoagulant market?
#msg-26451612 VTE is a big, big problem (Lancet 2008)
#msg-53285442 Clinical overview of the new oral anticoagulants (Blood)
#msg-53493902 Drug-design overview of the new oral anticoagulants (C&EN)
#msg-26701803 Technical overview of traditional anticoagulants
#msg-69033192 Doctors at AHA reserve judgment on new oral anticoagulants
#msg-76672526 Cardiologists remain cautious about new oral anticoagulants
#msg-82279707 How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?


Eliquis
#msg-82909596 PFE/BMY split worldwide profits 60/40
#msg-81069705 PTLA inks deal with BMY/PFE for Eliquis antidote

#msg-82876466 FDA approves Eliquis for AF/stroke prevention
#msg-82880113 US list price is $3K/year
#msg-79794323 European approval for AF/stroke prevention
#msg-83699519 NICE endorses Eliquis for AF/stroke prevention
#msg-82773478 Japanese approval for AF/stroke prevention
#msg-66604305 Phase-3 ARISTOTLE study hits all endpoints
#msg-66604998 Links to various write-ups on the ARISTOTLE data
#msg-66610218 Eliquis data in AF even better than Pradaxa’s (Dew)
#msg-64534413 BMY/PFE’s big win in AF (Matt Herper blog)
#msg-54576974 Eliquis superior to aspirin in phase-3 AVERROES study

#msg-61114160 EU approval for primary VTE prevention after hip/knee surgery
#msg-71274240 NICE backs Eliquis for primary VTE prevention after hip/knee surgery
#msg-58092961 ADVANCE-3 study succeeds in primary VTE prevention
#msg-82279247 Stellar 1-year data in secondary VTE prevention at ASH 2012
#msg-29928836 Phase-3 AMPLIFY study in acute VTE treatment
#msg-87310044 Status of sNDA plans in VTE prevention and treatment

#msg-68938689 Failure in VTE prevention for immobilized patients
#msg-56880416 Failure in ACS
#msg-78906819 ESC paper on transitioning patients from Eliquis to warfarin


Xarelto
#msg-68690569 FDA approval for AF/stroke prevention
#msg-67357050 EU approval for AF/stroke prevention)

#msg-64830766 FDA approval for VTE prevention following hip/knee surgery
#msg-30972846 EU approval for VTE prevention following hip/knee surgery

#msg-81103054 FDA approval for VTE treatment and secondary prevention
#msg-80711606 EU approval for VTE treatment and secondary prevention

#msg-88290069 EU approval in ACS
#msg-89488427 FDA issues secondCRL in PCI sub-indication of ACS
#msg-85274478 FDA issues CRL in ACS per se

#msg-85476223 JNJ/Bayer start five phase-3 trials in new indications
#msg-84232022 PTLA inks deal with JNJ/Bayer for Xarelto antidote


Pradaxa
#msg-74842220 Pradaxa has annualized sales of more than $1B
#msg-70694238 Pradaxa meta-analysis shows slightly increased CV risk
#msg-79235568 Pradaxa bleeding risk may be associated with a polymorphic gene
#msg-27956748 EU approves Pradaxa for primary VTE prevention
#msg-89322704 B-I submits MAA for acute treatment/secondary VTE prevention.
#msg-51315844 Non-inferior to Lovenox in VTE prevention (RE-NOVATE 2)
#msg-21155926 Non-inferior to Lovenox in VTE prevention (RE-NOVATE)
#msg-44244839 Data from first phase-3 trial in acute VTE

#msg-25152872 ACS program presumably dead (no update since 2007)

#msg-55725156 FDA approves Pradaxa in AF/stroke prevention
#msg-62113814 CHMP approves Pradaxa in AF/stroke prevention
#msg-76715895 Pradaxa similar to warfarin in AF peri-procedural bleeding rates


Lixiana (edoxaban)
#msg-48661173 Approval in Japan for primary VTE prevention
#msg-69845515 Japanese phase-3 data in primary VTE prevention
#msg-46218043 Global phase-3 in secondary VTE prevention
#msg-57277975 Global phase-3 in AF/stroke prevention
#msg-34100787 Comparable safety to warfarin in AF (phase-2)
#msg-89410130 PTLA inks deal with Daiichi Sankyo for edoxaban antidote


Betrixaban
#msg-61300408 Too little, too late? MRK returns rights to Portola
#msg-89329551 PTLA’s case for Betrixaban contains more than a modicum of spin
#msg-70839287 Phase-3 trial in VTE prevention of hospitalized patients
#msg-83957606 PTLA inks development deal for China


Arixtra
#msg-65132332 FDA approves generic Arixtra
#msg-54742945 Arixtra is wasteful in treatment of SVT
#msg-10569101 Arixtra bests Lovenox in ACS (2006 study)


Miscellaneous (in alphabetical order)
#msg-36811828 AZN reports phase-2 data for AZD0837
#msg-64489315 Endotis starts phase-2a trial for reversible anticoagulant
#msg-69953489 ISIS has a FVII inhibitor;
#msg-57275734 Octapharma pursues warfarin-reversal program
#msg-87707322 PTLA reports top-line phase-2 data for PRT-4445
#msg-82625248 RGDO’s program for REG1