Replies to post #116643 on Biotech Values

[DewDiligence]

BMY/PFE—No drug recommended by the CHMP has ever been denied approval by the EU, so Apixaban is as good as approved in the EU. It has the potential to be a big enough drug to move the needle even for companies as large as BMY and PFE.

Approval for VTE prevention in the EU may help to some degree with the FDA, although BMY/PFE have not seemed confident about making headway with the FDA in this indication (#msg-58061618).

p.s. The brand name, Eliquis, is a bizarre choice with a sound dangerously close to Elevess (the dermal filler).

[DewDiligence]

Eliquis (Apixaban) receives formal EU approval for marketing:

http://finance.yahoo.com/news/ELIQUIS-apixaban-Approved-In-bw-2785334351.html?x=0&.v=1

This is a rubber-stamping of the CHMP’s decision two months ago (#msg-61113322).

What about the US market? BMY/PFE have not sounded confident about making headway with the FDA for Eliquis in VTE prevention (#msg-58061618).

[DewDiligence]

UK’s NICE backs Eliquis for VTE prevention following hip/knee surgery:

http://www.bloomberg.com/news/2012-01-25/pfizer-bristol-myers-eliquis-recommended-by-u-k-cost-agency.html

Eliquis was formally approved in the EU for this indication only 8 months ago (#msg-63389697), so this is fast work (comparatively speaking) by NICE.

There is still no clear indication that Eliquis will ever be approved in the US in this indication (#msg-65788631).