Replies to post #127208 on Biotech Values

[DewDiligence]

What’s New in the Anticoagulant Arena?

[Darexaban paragraph removed (development terminated);
PYMX starts phase-1/2 trial of PMX-60056 for Lovenox reversal.]

See MNTA ReadMeFirst for additional info on Lovenox.


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


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-56880416 Failure in ACS

#msg-66604305 Phase-3 ARISTOTLE study in AF 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-67368764 How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?
#msg-19134406 BMY, PFE ink worldwide Eliquis partnership


Xarelto (rivaroxaban)
#msg-64830766 FDA approval in VTE prevention following hip/knee surgery
#msg-30972846 EU approval in VTE prevention following hip/knee surgery
#msg-44245112 Questionable data in secondary VTE prevention
#msg-61803303 Probable failure in VTE prevention for immobilized patients
#msg-67357050 CHMP approval in acute VTE treatment (also for AF)
#msg-53887547 Xarelto matches Lovenox/warfarin in acute DVT

#msg-39151366 Xarelto still has a long way to go in ACS
#msg-33517140 Phase-2 data in ACS

#msg-66936474 Advisory panel backs approval in AF despite FDA’s misgivings
#msg-66841463 FDA criticizes ROCKET-AF study
#msg-56712414 Xarelto non-inferior to warfarin in ROCKET-AF study
#msg-56717469 Musings on Xarelto’s superiority claim in AF (or lack thereof)
#msg-63567346 Subgroup data from ROCKET-AF in secondary prevention
#msg-67357050 CHMP approval in AF (also for acute VTE treatment)

#msg-67368764 How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?


Pradaxa (dabigatran)
#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-67368764 How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?


Lixiana (edoxaban)
#msg-48661173 Musings on approval in Japan for VTE prevention
#msg-46218043 Global phase-3 in VTE prevention
#msg-57277975 Global phase-3 in AF/stroke prevention
#msg-34100787 Comparable safety to warfarin in AF (phase-2)


Betrixaban
#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-41143344 Ablynx starts phase-2 of ALX-0081 in PCI
#msg-40720487 Ablynx phase-1 ALX-0681 results in healthy volunteers
#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-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-27187973 Paion’s Solulin completes phase-1
#msg-28742653 Paion acquires flovagatran rights
#msg-56742275 Portola targets LMWH reversal
#msg-67447063 PYMX starts phase-1/2 for Lovenox reversal
#msg-50887012 PYMX phase-1b data for InnoHep reversal
#msg-59697467 PYMX starts phase-2 for heparin reversal in PCI
#msg-53193787 PYMX phase-1/2 data for heparin reversal
#msg-55348772 Regado’s phase-2a data for RB006/RB007
#msg-55640856 Musings on Regado’s threat to MNTA’s M118
#msg-63888132 SNY reports phase-3 data for Semuloparin (f/k/a AVE5026)
#msg-46648462 SNY’s Otamixaban is not quite dead (yet)
#msg-53375883 Takeda’s TAK-442 in ACS and VTE prevention
#msg-62473925 TB-402 (FVIII inh) enters phase-2b
#msg-60525364 Warfarin pharmacogenetics study sponsored by CMS