Abbott Labs (ABT - Free Report) 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 structural damage.
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 Pfizer/Amgen’s (PFE - Free Report) /(AMGN - Free Report) Enbrel, Johnson & Johnson/Merck’s (JNJ - Free Report) /(MRK - Free Report) Remicade and Simponi.
We currently have a Neutral recommendation on Abbott Labs, which carries a Zacks #3 Rank (short-term ‘Hold’ rating).