Replies to post #77313 on Biotech Values

[genisi]

Bayer, J&J say FDA wants more data on Xarelto

http://www.reuters.com/article/rbssHealthcareNews/idUSLR95960620090528

* Gets so-called "complete response letter"

* No new clinical or non-clinical studioes needed

* Confident questions raised can be promptly addressed


FRANKFURT, May 28 (Reuters) - Bayer (BAYG.DE: Quote, Profile, Research, Stock Buzz) and Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) said on Thursday the U.S. Food and Drug Administration declined to approve their experimental blood thinning pill Xarelto, asking for more information.

In a so-called "complete response letter" the FDA has, however, not requested that any new clinical or non-clinical studies be conducted to evaluate the drug -- known scientifically as rivaroxaban -- the companies added.

The drug is already approved in Europe to prevent blood clots after major orthopaedic surgery, and the two companies are also seeking clearance for the potential blockbuster in the United States, its largest market.

The pill was backed by an FDA advisory committee in March for use in knee and hip replacement patients despite concerns over possible side-effects and worries about long-term use.

The drug's blockbuster potential lies in the planned use to prevent strokes in patients suffering from atrial fibrilation, a common form of irregular heartbeat, with market launch not seen before 2011.

In its use after orthopaedic surgery, the oral drug is a rival to Sanofi-Aventis' (SASY.PA: Quote, Profile, Research, Stock Buzz) injectable treatment Lovenox, a standard treatment based on heparin.

Bayer's privately-held German rival Boehringer Ingelheim said it is about one and a half years ahead in the race to bring its blood-thinning pill Pradaxa to the mass market of stroke prevention but analysts say it remains open to question how it will fare against Xarelto.

[DewDiligence]

ANTICOAGULANT INDEX

[FDA requests more data on Xarelto NDA in VTE prevention.
Please see MNTA ‘ReadMeFirst’ for info on M118.]


General
#msg-37480173 Market overview from May 2009 Nature
#msg-25160571 Anticoagulant market has large potential (WSJ 2007)
#msg-26899903 Anticoagulant market has large potential (graphic)
#msg-26451612 VTE is a big, big problem (Lancet 2008)
#msg-26701803 Technical information on traditional anticoagulants


Xarelto (rivaroxaban)
#msg-38215993 Xarelto can move the needle even for JNJ
#msg-30972846 EMEA approves Xarelto for VTE prevention
#msg-38200098 FDA requests more data on NDA in VTE prevention
#msg-34103973 Phase-3 data in VTE prevention (JNJ PR)
#msg-29661234 Phase-3 data in VTE prevention (Reuters)
#msg-31857009 Bayer accelerates Xarelto development
#msg-33517140 Phase-2 data in ACS
#msg-29662519 Rivaroxaban rationale
#msg-24337258 Bayer plans 50,000(!)-patient study


Apixaban
#msg-31742223 Apixaban fails vs Lovenox in phase-3
#msg-32024540 Tepid phase-2 results in ACS
#msg-19134406 PFE, BMY ink $1B collaboration
#msg-29928836 Seventh and eighth phase-3 trials begin
#msg-21044973 Apixaban non-inferior to Warfarin in phase-2


Pradaxa (dabigatran)
#msg-32382343 NICE approves Pradaxa in only six months
#msg-27956748 EU approves Pradaxa for VTE prevention
#msg-26086079 BI completes enrollment of huge AF trial
#msg-25152872 BI starts phase-2 in ACS
#msg-21155926 Dabigatran non-inferior to Lovenox in VTE prevention


DU-176b
#msg-34100821 Phase-3 begins in AF
#msg-34100787 Comparable Safety to Warfarin in AF (phase-2)
#msg-31950663 Phase-2 data in hip surgery


Lovenox
#msg-26739674 US market share
#msg-28936334 Where Lovenox sales come from
#msg-33630772 Lovenox not more costly than Arixtra (CHEST 2008)
#msg-11669012 Lovenox more economical than unfractionated heparin


Miscellaneous (in alphabetical order)
#msg-36667428 Ablynx reports phase-1b ALX-0681 results in PCI
#msg-10569101 Arixtra bests Lovenox in ACS
#msg-27043616 ART-123 from Artisan Pharma
#msg-33309473 ARYX ATI-5923: A safer warfarin?
#msg-22938795 AVE5026 and otamixaban (SR123781 dropped Feb08)
#msg-36811828 AZN reports phase-2 data for AZD0837
#msg-26298260 Biotinylated idraparinux causes excess bleeding
#msg-30965016 LLY terminates FXa program
#msg-30353872 MYGN MPC-0920 begins phase-1
#msg-31461171 NUVO reports phase-1b data for NU172
#msg-27187973 Paion’s Solulin completes phase-1
#msg-28742653 Paion acquires flovagatran rights
#msg-21106352 Portola’s phase-2 data not impressive (IMO)
#msg-32171800 Regado reports phase-1 data for aptamer
#msg-35794827 ThromboGenics, BioInvent start phase-2 trial of TB-402
#msg-37562465 Warfarin genetic test rejected by Medicare