Pfizer ($PFE) has posted a fresh set of upbeat data on its top blockbuster prospect tofacitinib that will go a long way to easing the sting of its recent bapineuzumab debacle. At high doses, the oral treatment performed significantly better than a placebo in treating ulcerative colitis in a mid-stage study, offering the prospect of building a major anti-inflammatory franchise.
The pharma giant has already won an advisory panel vote backing its bid to gain an approval for tofacitinib as a new treatment for rheumatoid arthritis. And now it's building a late-stage program to follow up on its mid-stage data for ulcerative colitis. Investigators report that of the patients taking the highest dose, 78% of patients achieved a reduction in symptoms, compared to 42% in the placebo arm. The dose escalation study also marked a 61% response at the second-highest dose.
The data is particularly important because a new oral therapy would offer fresh hope for the large portion of patients who can't tolerate the two injectable therapies now in use, including Remicade, notes Bloomberg's story.
Pfizer will start putting its experimental therapy to the test in three large, late-stage studies, which will go far past the 8-week regimen patients experienced in Phase II.
For now, Pfizer has relatively good odds of achieving an approval for the treatment for rheumatoid arthritis, and has been gathering data that can help persuade skeptical payers of its efficacy--a key concern for analysts. This new data--reported in the Aug. 16 issue of the New England Journal of Medicine--will help it make a case that tofacitinib sales could break the $2 billion barrier.
- here's the story from Bloomberg
- read the Dow Jones piece
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Pfizer's tofacitinib on the rise: late-stage drug well-positioned for FDA approval, market success.
Started by @JohnCFierce
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