Oct. 14--Another week, and another competitor is nipping at the heels of AbbVie Inc.'s rheumatoid arthritis treatment Humira, the top-selling drug in the world.
This time it's Eli Lilly and its biotech partner Incyte Corp., which on Wednesday announced that their experimental drug baricitinib proved superior to Humira in a large study, raising questions about whether AbbVie of North Chicago can protect a product that generated $12.5 billion in sales last year.
That announcement came just a week after drugmaker Baxalta and partner Momenta Pharmaceuticals said they were moving into late-stage clinical trials with a biosimilar, or low-cost version of Humira, for treating chronic plaque psoriasis, a condition that causes itchy, painful red patches on the skin.
"Everyone is wondering how much longer AbbVie can fend off the competition," said Les Funtleyder, a health analyst for E Squared Capital, a New York hedge fund. "My guess is patients who are on Humira will stay on Humira, but doctors might put new patients on another drug to see if it might perform better."
Lilly's experimental drug is a once-a-day oral treatment for rheumatoid arthritis, which might prove more popular with patients who are burned out from giving themselves shots, Funtleyder said. Humira is an injectable.
Lilly sounded a similar note.
"If approved, baricitinib could help change expectations for people living with this debilitating disease," said David Ricks, Lilly's senior vice president.
Analysts questioned the new drug's safety because during the clinical trial baricitinib racked up serious adverse events at a similar rate as a placebo, but higher than Humira.
"We are particularly interested in the detailed safety data from the trial and also long-term safety, which we believe would be a major driver" for sales of baricitinib for treating rheumatoid arthritis, wrote Dr. Mark Schoenebaum, a drug and biotech analyst at Evercore ISI in New York.
Humira, which accounted for about two-thirds of AbbVie's revenues of $19.9 billion last year, is approved to treat nine conditions, making it one of the most prescribed drugs on the market. But it will lose its patent exclusivity late next year, meaning it will likely face competition from biosimilars.
Morningstar estimates AbbVie could lose nearly 40 percent of its revenue by 2020. Seven biosimilars are in late-stage development.
AbbVie said that Humira has a comprehensive record of clinical effectiveness, a "well-studied safety profile" and breadth of approved uses "that will ensure it remains a strong, sustainable growth brand."
jrussell@tribpub.com
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