Replies to post #151846 on Biotech Values

[DewDiligence]

Xeljanz phase-3 scorecard (for archival purposes):

#msg-78087124

p.s. Xeljanz would be one of the best 7-letter Scrabble words if proper nouns were allowed.

[DewDiligence]

PFE held a CC at 6pm ET on the Xeljanz approval:

http://finance.yahoo.com/news/u-food-drug-administration-approval-222500393.html

I did not listen (yet).

[DewDiligence]

Reuters chimes in on Xeljanz approval—price is ~$25K*/year:

http://www.reuters.com/article/2012/11/06/pfizer-arthritis-idUSL1E8M6D8820121106

Note: The FDA approved only the 5mg dose, not the 10mg dose that was also tested in phase-3 trials. However, the non-approval of the 10mg dose is (IMO) less consequential than the broadness of the second-line label (i.e. no requirement for prior treatment with a TNF-alpha drug).

*This was subsequently confirmed by PFE.

[DewDiligence]

In blow to PFE, Xeljanz LT-safety_study_misses_non-inferiority_endpoints_compared_to_Humira/Enbrel:

https://finance.yahoo.com/news/pfizer-shares-co-primary-endpoint-114500861.html

The study in question was a post-marketing requirement from the FDA’s approval of Xeljanz in 2012. Whether Xeljanz’s label will be updated as a result of the study is unclear at this point.

Xeljanz has annualized worldwide sales of ~$2.5B.

p.s. “Shares” is evidently the new “updates” for biotech PRs bearing bad news.