Replies to post #146402 on Biotech Values

[DewDiligence]

The bear case for Tofacitinib, such as it is:

http://seekingalpha.com/article/581661-pfizer-is-8-really-enough

[DewDiligence]

FDA extends Tofacitinib PDUFA date 3 months to 11/21/12, as expected:

http://finance.yahoo.com/news/u-food-drug-administration-extends-123000572.html

The 3-month delay was expected because PFE said so on its 2Q12 CC in July.

Tofacitinib has an 85% chance of approval on the first review cycle, IMO. I concur with genisi’s assessment in #msg-75539892—i.e. the unmet medical need will trump the ambiguity wrt Tofacitinib’s results in the (non-primary endpoint) of radiographic progression relative to the control arm.

I expect the FDA to grant Tofacitinib a third-line label; if the FDA grants a second-line label, it will be a pretty big win for PFE.

[DewDiligence]

GSK/JNJ start phase-3 RA trials for Sirukumab:

http://www.reuters.com/article/2012/08/23/us-johnsonjohnson-gsk-drugtrial-idUSBRE87M0H420120823

One phase-3 trial is in the second-line setting (following MTX) and one is effectively in the third-line setting (following a TNF-a drug). Both trials have placebo as the comparator, but only the third-line trial has radiographic progression as an endpoint.

[DewDiligence]

FDA approves PFE’s Xeljanz (f/k/a tofacitinib) for second-line RA:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm327152.htm

The U.S. Food and Drug Administration today approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.

This is the broad second-line label that PFE has been hoping for.