Pfizer's blockbuster RA hopeful clears a Ph3 hurdle
Pfizer ($PFE) has some upbeat Phase III data to report this morning. The pharma giant says that its oral JAK inhibitor tofacitinib--which recently underwent a name change from tasocitinib--hit its primary endpoint for statistical significance among patients with rheumatoid arthritis. The experimental therapy, probably one of Pfizer's biggest late-stage blockbuster prospects, hit its marks for reducing symptoms of RA.
Investigators are holding back the full data set for a later scientific meeting, But news of the late-stage success strikes a positive note as Pfizer restructures its R&D operations, vowing to overcome earlier setbacks in the clinic. The drug targets the intracellular signaling pathways--rather than extracellular targets--that operate as hubs in the inflammatory cytokine network. And analysts have been buzzing over its potential for RA as well as a full slate of other inflammatory conditions.
It is, noted Sanford C. Bernstein's Timothy Anderson, "one of the most exciting compounds in the pharmaceutical industry's collective pipeline."
So why the name change? Forbes' Matthew Herper asked earlier this week and was told that the old name "sounded too similar to other trade names and INNs [International Nonproprietary Names]. The World Health Organization's INN Expert Committee preliminarily approved tasocitinib as the Proposed INN name in January 2010. During the Proposed INN objections period, a successful objection was filed which necessitated the name change. Specifically, tasocitinib sounded too similar with the trade name TAZOCILLINE and with the INNs tazobactum and dacomitinib."
Whatever you call it, the therapy has passed a key Phase III hurdle and has now been tested in more than 4,000 patients. That's a big step forward for Pfrizer.