) recently presented phase III data on its blockbuster drug,
Humira, from two studies. While ABILITY-2 is being conducted in
patients with active peripheral spondyloarthritis (PSpA) who have
not been diagnosed with psoriatic arthritis (PsA) or ankylosing
spondylitis (AS), ABILITY-1 is being conducted in patients with
axial spondyloarthritis (axSpA) who have no X-ray evidence of
Abbott Labs said that 39.3% of patients in the Humira arm
achieved the primary endpoint compared to 19.8% of patients on
placebo. The primary endpoint was an improvement of at least
40% in the peripheral SpA response criteria (PSpARC 40).
Meanwhile, results from the ABILITY-1 study showed that 36.3% of
patients in the Humira arm achieved ASAS 40 compared to 14.9% of
patients in the placebo arm at 12 weeks.
Abbott Labs presented these results at the European League
Against Rheumatism (EULAR) 2012 Congress.
Humira is a key product in Abbott Labs' pharmaceutical products
portfolio. Humira is approved for several indications including
rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,
psoriasis, juvenile idiopathic arthritis, and Crohn's disease.
Humira sales increased 21.1% to $7.9 billion in 2011. Growing
awareness, favorable clinical data, additional indications and
expansion into new markets like China and Japan should help the
product to continue contributing significantly to the top-line.
Moreover, approval for additional indications would boost peak
sales forecasts for the drug significantly. Earlier this year,
Humira gained approval for an additional indication in the EU. The
European Commission cleared Humira for treating adults suffering
from moderately to severely active ulcerative colitis (UC). The
product gained approval for use in patients who did not respond
satisfactorily to standard drugs for UC treatment.
Other players in the anti-inflammatory market include
Johnson & Johnson
) Remicade and Simponi.
We currently have a Neutral recommendation on Abbott Labs, which
carries a Zacks #3 Rank (short-term 'Hold' rating).
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