No new colitis indication for Abbott Laboratories' ($ABT) Humira--yet. The FDA has asked for more information from Abbott, postponing its decision on the new indication for several more months. With 500,000 patients in the U.S., ulcerative colitis would be a big new market for Humira to target.
The timing for the delay isn't ideal: Abbott Laboratories is preparing to spin off its pharma division into a new company called AbbVie. The keystone of that new company is Humira and its $7.9 billion in 2011 sales, so the bigger Humira's prospects at IPO time, the better. Analysts had predicted an increase in 2012 sales to $9 billion with the colitis use, PM Live says.
Plus, Humira doesn't have an eternity of exclusivity left; its patent expires in 2016. So, Abbott/AbbVie needs to capture as much revenue from it as possible.
An Abbott spokeswoman told Bloomberg that the company has already handed over more information to FDA. The complete response letter came "several months ago," Abbott's Elizabeth Hoff told the news service. "We're anticipating a decision by the end of the year."
Humira wouldn't have the colitis market to itself; Johnson & Johnson's ($JNJ) Remicade is approved for that use in patients who fail on first-line drugs. Meanwhile, Johnson & Johnson is developing Simponi--a follow-up to Remicade--for ulcerative colitis. The company just reported data from a new study, showing symptom relief in a majority of patients using the drug, compared with about 29% of placebo; all the patients had failed on standard therapy.