Replies to post #139191 on Biotech Values

[DewDiligence]

JNJ’s own PR on the Xarelto results in pulmonary embolism:

http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=659354

[DewDiligence]

JNJ submits Xarelto NDA for treatment and secondary prevention of VTE:

http://finance.yahoo.com/news/janssen-research-development-submits-xarelto-130000593.html

Venous thromboembolism (VTE) is a composite of deep vein thrombosis (DVT) and pulmonary embolism (PE), although the PE portion often gets short shrift in clinical studies. JNJ, however, ran a study called EISSTEIN-PE especially for patients for symptomatic PE (#msg-73685353). Along with the phase-3 EINSTEIN-DVT study, which finished two years ago (#msg-53887547), JNJ now has enough data to seek approval for the dual indications mentioned in the header of this post.

In the EU, Xarelto is approved for acute VTE treatment (#msg-67357050—chase the embedded link), but not specifically for secondary prevention of VTE.

In both the US and EU, Xarelto is approved for primary prevention of VTE following hip/knee surgery.

(In the Lovenox competitive analysis in #msg-69173426, the indications for which JNJ is seeking FDA approval are the ones in paragraph C and paragraph D.)

[DewDiligence]

CHMP approves Xarelto for treatment of PE and secondary prevention of VTE:

http://www.press.bayer.com/baynews/baynews.nsf/id/Bayers-Xarelto-Rivaroxaban-Recommended-EU-Approval-Treatment-Pulmonary-Embolism-PE-Prevention?OpenDocument&sessionID=1350667966

The PDUFA date for this indication is on or about 11/2/12; JNJ is Bayer's partner in the US market.