Recently revealed data show a study of Abbott Laboratories (ABT) drug Humira and its ability to treat the skin disease psoriasis exceeded expectations and topped results in an earlier trial, an Abbott official said Tuesday.
Results from the Phase 3 trial have not yet been publicly released and will be presented at a conference early next month. But data in the trial were recently "unblinded," and Humira showed "significantly better efficacy than approved biologics" in psoriasis treatment, said Thomas Freyman, Abbott's chief financial officer.
Freyman spoke at a Bear Stearns conference that was broadcast on the Internet.
The recent trial looked at Humira, a placebo and methotrexate - a standard drug used for years to treat psoriasis - to see which treatment scored best after 16 weeks on a standard scale of psoriasis treatment. The recently revealed data showed that the trial was better than expected and better than a Phase 2 trial, Freyman said.
An Abbott spokeswoman confirmed that the latest trial met its primary endpoint, or goal. Safety information from the trial will be released, along with more specific trial data, at October's European Academy of Dermatology and Venereology conference in Rhodes, Greece.
Humira, which posted $1.4 billion in global sales last year, is currently approved to treat rheumatoid arthritis, arthritis of the spine and psoriatic arthritis - but not psoriasis itself. Abbott plans to file with the U.S. Food and Drug Administration for psoriasis-treatment approval in the first half of 2007.
The skin disease is one of multiple indications that could significantly expand Humira's reach and revenue-generating potential if the treatment is approved.
Abbott announced last week that it has filed with U.S. and European regulators seeking approval to market Humira for the treatment of moderate to severe Crohn's disease, a serious and chronic intestinal inflammatory disorder.
Abbott also plans to file with the FDA next year, seeking approval to use Humira to treat juvenile rheumatoid arthritis and ulcerative colitis, another intestinal inflammatory disease.
Freyman said Abbott continues to target Humira sales of more than $1.9 billion this year, and noted that his company has said that the new indications alone represent a multibillion-dollar opportunity.
"Humira continues to meet or exceed our expectations," he said at the Bear Stearns conference.
"This is a product that's got legs," he added.
Humira is part of a class of treatments called tumor necrosis factor antagonists, or anti-TNF. TNF is a substance believed to play a role in inflammatory conditions.
article by Jon Kamp
