The drug: Humira
The companies: Abbott Laboratories/Eisai
Estimated worldwide sales 2012: $9.48 billion
Abbott Laboratories ($ABT) has a lot riding on Humira. The company is spinning off its pharmaceuticals division, and the new company's centerpiece will be none other than the anti-inflammatory drug. Good thing it is poised to become the top-selling drug in the world.
The drug accounted for $7.9 billion of Abbott's 2011 sales, up from $6.5 billion in 2010 and $5.5 billion the year before that. Approved in 2003 for rheumatoid arthritis, Humira has taken billion-dollar leaps with help from a series of new indications: psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn's disease, and now, ulcerative colitis. In early October, the FDA approved that 7th indication, in a chronic disease that affects some 620,000 patients in the U.S. Analysts say the ulcerative colitis use could add another $500 million or more to Humira sales.
As that spinoff nears, the company is circling the wagons in an effort to protect Humira from biosimilars. Abbott filed a citizen's petition to hold off copycat versions, claiming FDA would need access to Abbott trade secrets to determine whether those copies were properly rendered. As a bonus legal argument, Abbott also claimed that FDA shouldn't approve copies of any biologic drug approved before biosimilars legislation passed in 2010.
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