Replies to post #132914 on Biotech Values

[DewDiligence]

ISIS announces three new drug candidates and a CC at noon ET tomorrow to discuss them:

http://finance.yahoo.com/news/Isis-Adds-Three-New-Drugs-Its-prnews-3637581772.html?x=0

One of the three compounds is an anticoagulant that inhibits Factor VII. To my knowledge, no other company has attempted—or is attempting—to do this.

[DewDiligence]

Pradaxa meta-analysis shows slightly increased CV risk:

http://www.reuters.com/article/2012/01/09/us-drugs-pradaxa-idUSTRE80825W20120109

The relative increase in risk to comparative medicines was found to range from 27 to 33 percent; however, the absolute risk increase for suffering a heart attack was only 0.27 percent, the authors of the meta-analysis said in the study published on Monday in the Archives of Internal Medicine online edition.

Doctors from the Cleveland Clinic conducted the meta-analysis based on data from seven clinical trials of Pradaxa involving more than 39,500 patients. The studies compared Pradaxa to either warfarin, enoxaparin - another widely used blood thinner sold under the band name Lovenox - or a placebo. The meta-analysis also found that the rate of death was lower for patients who received Pradaxa than those got other medicines in the clinical trials - 4.83 percent versus 5.02 percent in the control groups.

This has no commercial consequence, IMO.

[DewDiligence]

Bayer expects Xarelto approval in China for AF/stroke prevention during 2013:

http://www.reuters.com/article/2012/02/09/healthcare-bayer-china-idUSL4E8D90Z920120209

Xarelto has already won approvals from the United States, European Union, Malaysia and Japan for use to prevent stroke in patients with atrial fibrillation, or an irregular heartbeat. Approvals from other countries are expected in coming months.

…One out of every five deaths in China is now due to stroke…

A remarkable figure; however, not all stroke deaths are related to attril fib, so the above overstates the addressable market for Xarelto to some degree.

[DewDiligence]

What’s New in the Anticoagulant Arena?

[Pradaxa has annualized sales of more than $1B;
Pradaxa meta-analysis shows slightly increased CV risk;
Eliquis has no FDA advisory panel for AF/stroke prevention (bullish);
NICE backs Eliquis for VTE prevention after hip/knee surgery;
FDA advisory panel rejects Xarelto for ACS;
Xarelto is no-go for VTE prevention in immobilized patients;
JNJ submits Xarelto NDA for VTE treatment and *secondary* prevention;
Xarelto phase-3 results in secondary prevention of pulmonary embolism;
PYMX cans PMX-60056 program (entries deleted);
ThromboGenics terminates TB-402 program (entry deleted);
ISIS has a FVII inhibitor;
Portola starts ph-3 Betrixaban trial in VTE prevention of hospitalized patients (good luck with that!)]



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-69173426 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-74663775 No FDA advisory panel for AF/stroke prevention
#msg-69422202 FDA grants priority review for Eliquis in 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-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-75129668 JNJ submits NDA 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-75912033 FDA advisory panel rejects Xarelto for ACS;
#msg-68962549 Xarelto hits primary endpoint in ACS (NEJM)
#msg-68962285 Xarelto hits primary endpoint in ACS (theHeart.org)
#msg-69122895 Musings on ACS results (urche)
#msg-69172520 Musings on ACS results (Dew)
#msg-69033192 Doctors at AHA reserve judgment on new oral anticoagulants

#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


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-56742275 Portola targets LMWH reversal
#msg-68770375 Regado’s phase-2b data for RB006/RB007
#msg-55640856 Musings on Regado’s program
#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