Biotech Values

[DewDiligence]

What’s New in the Anticoagulant Arena?

[Entry for warfarin pharmacogenetics study sponsored by CMS.]

See MNTA ReadMeFirst for info on Lovenox and M118.


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


Xarelto (rivaroxaban)
#msg-58426102 Bayer/JNJ make regulatory submissions in EU and US (1)
#msg-58447066 Bayer/JNJ make regulatory submissions in EU and US (2)
#msg-56712414 Xarelto non-inferior to warfarin in ROCKET-AF study
#msg-56717469 Musings on Xarelto’s superiority claim (or lack thereof)
#msg-56742484 Musings on the relative merits of Xarelto and Pradaxa
#msg-56769950 Musings on the relative merits of Xarelto/Apixaban/Pradaxa
#msg-53887547 Xarelto matches Lovenox/warfarin in acute DVT
#msg-44245112 Troublesome bleeding in VTE extension study
#msg-30972846 EMEA approves Xarelto for VTE prevention
#msg-34103973 Phase-3 data in VTE prevention (JNJ PR)
#msg-29661234 Phase-3 data in VTE prevention (Reuters)
#msg-39151366 Xarelto still has a long way to go in ACS
#msg-33517140 Phase-2 data in ACS
#msg-29662519 Checklist rationale for Xarelto program


Pradaxa (dabigatran)
#msg-55725156 FDA approves Pradaxa in AF/stroke prevention
#msg-51498625 Musings on Pradaxa in various indications
#msg-56742484 Musings on the relative merits of Xarelto and Pradaxa
#msg-56769950 Musings on the relative merits of Xarelto/Apixaban/Pradaxa
#msg-41018490 Pradaxa bests warfarin in AF/stroke prevention (Reuters)
#msg-27956748 EU approves Pradaxa for VTE prevention
#msg-32382343 NICE approves reimbursement for 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 Phase-3 Pradaxa data in acute VTE (ASH 2009)
#msg-25152872 BI starts phase-2 trial in ACS


Apixaban
#msg-56880416 Apixaban fails in ACS
#msg-54576974 Phase-3 succeeds in warfarin-free AF/stroke prevention
#msg-56769950 Musings on the relative merits of Xarelto/Apixaban/Pradaxa
#msg-58092961 ADVANCE-3 study succeeds in VTE prevention
#msg-58061618 Overview of VTE-prevention program (ADVANCE-1,2,3)
#msg-29928836 Phase-3 trials begin for VTE treatment
#msg-19134406 PFE, BMY ink $1B deal to co-develop Apixaban


Betrixaban
#msg-39418241 MRK licenses betrixaban (WSJ)
#msg-39388813 MRK licenses betrixaban (MRK/Portola PR)
#msg-47847796 Phase-2 safety data vs warfarin in AF
#msg-21106352 Phase-2 data vs Lovenox in VTE prevention


Edoxaban
#msg-48661173 Daiichi Sankyo files for approval in Japan
#msg-46218043 Largest-ever phase-3 begins in VTE prevention
#msg-57277975 Phase-3 completes 21,000-patient enrollment in AF
#msg-34100787 Comparable safety to warfarin in AF (phase-2)
#msg-31950663 Phase-2 data in VTE prevention after hip surgery


Darexaban (YM150)
#msg-55022218 Astellas seeks approval for VTE prevention in Japan
#msg-55025487 Overview of Darexaban programs in various indications


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-54742945 Arixtra is wasteful in treatment of SVT
#msg-10569101 Arixtra bests Lovenox in ACS (2006 study)
#msg-39348082 ARYX’s Tecarfarin whiffs in phase-3
#msg-36811828 AZN reports phase-2 data for AZD0837
#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-59697467 PYMX phase-2 for herapin reversal in PCI
#msg-50887012 PYMX phase-1b data for Lovenox reversal
#msg-53193787 PYMX phase-1b/2a 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-46648462 Sanofi’s stable of anticoagulant aspirants
#msg-53375883 Takeda’s TAK-442 in ACS and VTE prevention
#msg-52169431 TB-402 (FVIII inh) bests Lovenox in VTE prevention
#msg-60525364 Warfarin pharmacogenetics study sponsored by CMS