Biotech Values

[DewDiligence]

PFE—Xeljanz shows mixed outcomes in phase-4 comparisons to Humira:

http://finance.yahoo.com/news/pfizer-announces-top-line-results-130000824.html

Pfizer Inc. announced today top-line results from ORAL Strategy, a Phase 3B/4 study of XELJANZ\ 5mg twice daily (BID) in the treatment of moderate to severe rheumatoid arthritis. ORAL Strategy is the first trial to compare a JAK inhibitor as monotherapy or in combination with methotrexate (MTX) versus adalimumab (Humira) plus MTX in MTX inadequate responders using ACR50 at Month 6 as the primary endpoint.

There were three comparisons, which found:

• XELJANZ 5mg plus MTX met its primary endpoint in demonstrating non-inferiority versus Humira plus MTX [so far, so good]

• XELJANZ 5mg monotherapy did not meet its primary endpoint of non-inferiority versus Humira plus MTX or versus XELJANZ plus MTX [oops]

Voluntary* phase-4 trials are risky, which is why they don’t happen that often.

A few years ago, many investors thought Xeljanz would be the undoing of Humira. In fact, it's not a stretch (IMO) to say that the perceived Xeljanz threat was one of the main drivers of the ABT-ABBV separation. Things sure have changed since then.

*I.e. those not part of post-marketing commitments to regulators.