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Rheumatoid arthritis therapy Xeljanz hasn't gotten off to the start Pfizer ($PFE) hoped, but new indications could give it a boost. On that front, the company reported positive results on Monday from a pair of trials evaluating the med in ulcerative colitis.
The two studies--dubbed OCTAVE 1 and 2--both met their primary endpoints, measured by the proportion of Xeljanz patients in remission after 8 weeks of treatment compared with patients on placebo. And in the process, no new or unexpected safety concerns cropped up, Pfizer said.
The trials are part of a group of four expected to form a potential regulatory submission package for a UC nod--and that's one the med could use. The chronic condition affects millions of people around the world, and Xeljanz is the first in its class of JAK inhibitors to be studied in the population.
Right now, the therapy only boasts a green light in RA, where stiff competition from meds like Amgen's ($AMGN) Enbrel and AbbVie's ($ABBV) Humira has tamped down sales. In Q2, the drug posted $128 million in sales, bringing its 6-month total to $224 million. That tally doesn't quite measure up to the blockbuster numbers industry-watchers predicted; early projections pegged peak annual sales at $3 billion, but two years back, analysts put forecasts at $1.6 billion by 2016.
Pfizer has been testing Xeljanz in psoriasis, too, but that's another tough field--and one that's only growing more crowded. Earlier this year, Novartis ($NVS) won FDA approval for its next-gen therapy, Cosentyx, the first in a wave coming up Big Pharma pipelines. Johnson & Johnson ($JNJ) and Merck ($MRK) are developing their own weapons, and earlier this month, Valeant ($VRX) picked up the exclusive development and commercialization rights on an AstraZeneca ($AZN) candidate.
- read the release
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