Biotech Values

[DewDiligence]

What’s New in the Anticoagulant Arena?

[JNJ withdraws Xarelto NDA in PCI, but gets priority review for NDA in
VTE treatment; SNY’s Semuloparin effectively dead with withdrawal of MAA.]



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-76857091 How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?


Eliquis (apixaban)
#msg-61114160 Approval in EU for VTE prevention…
#msg-58061618 …but FDA evidently has concerns (ADVANCE-1 and -2)
#msg-58092961 ADVANCE-3 study succeeds in VTE prevention
#msg-29928836 Phase-3 trials for acute VTE treatment
#msg-71274240 NICE backs Eliquis for VTE prevention after hip/knee surgery

#msg-68938689 Failure in VTE prevention for immobilized patients
#msg-56880416 Failure in ACS

#msg-76925814 FDA issues CRL for Eliquis in AF…
#msg-76926354 …but CRL sounds like it’s easily fixable
#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-19134406 BMY, PFE ink worldwide Eliquis partnership


Xarelto (rivaroxaban)
#msg-64830766 FDA approval for VTE prevention following hip/knee surgery
#msg-30972846 EU approval for VTE prevention following hip/knee surgery
#msg-61803303 Probable failure in VTE prevention for immobilized patients
#msg-67357050 CHMP approval for acute VTE treatment (also for AF)
#msg-71328639 Xarelto is no-go for VTE prevention in immobilized patients
#msg-77346396 FDA grants priority review for VTE treatment & secondary prevention
#msg-73685353 Ph-3 results in secondary prevention of pulmonary embolism
#msg-53887547 Xarelto matches Lovenox/warfarin in acute DVT

#msg-76856261 FDA issues CRL for Xarelto in ACS
#msg-77346396 JNJ withdraws “companion” NDA in PCI sub-indication of ACS

#msg-68690569 FDA approval for AF/stroke prevention
#msg-67357050 CHMP approval for AF (also for acute VTE treatment)


Pradaxa (dabigatran)
#msg-74842220 Pradaxa has annualized sales of more than $1B
#msg-70694238 Pradaxa meta-analysis shows slightly increased CV risk

#msg-27956748 EU approves Pradaxa for VTE prevention (but what about FDA?)
#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)


Betrixaban
#msg-70839287 Phase-3 trial in VTE prevention of hospitalized patients
#msg-61300408 Too little, too late: MRK returns rights to Portola
#msg-47847796 Phase-2 safety data vs warfarin in AF
#msg-21106352 Phase-2 data vs Lovenox in VTE prevention


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-68884274 Ablynx dumps ALX-0081 program in ACS
#msg-39348082 ARYX’s Tecarfarin whiffs in phase-3
#msg-67480148 Astellas terminates development of darexaban (YM150)
#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-30965016 LLY terminates FXa program
#msg-30353872 MYRX MPC-0920 begins phase-1
#msg-31461171 NUVO reports phase-1b data for NU172
#msg-57275734 Octapharma pursues warfarin-reversal program
#msg-46648382 Otamixaban ho-hum in phase-2 ACS study
#msg-76672265 Portola starts phase-1 trial of FXa antidote, PRT4445
#msg-68770375 Regado’s phase-2b data for RB006/RB007
#msg-55640856 Musings on Regado’s program
#msg-77317909 SNY’s Semuloparin effectively dead with withdrawal of MAA
#msg-46648462 SNY’s Otamixaban is not quite dead (yet)
#msg-53375883 Takeda’s TAK-442 in ACS and VTE prevention