) and its partner Reata Pharmaceuticals, Inc. recently announced
the discontinuation of the pivotal phase III BEACON (Bardoxolone
methyl EvAluation in patients with Chronic kidney disease and
type II diabetes: the Occurrence of renal eveNts) study with
bardoxolone methyl. The study was being conducted to evaluate the
safety and efficacy of bardoxolone methyl in patients with stage
4 chronic kidney disease (CKD) and type II diabetes.
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The study was terminated after the Independent Data Monitoring
Committee (IDMC) recommended discontinuation of the study due to
safety concerns. It was found that a higher number of serious
adverse events and mortality was associated with the use of
Investors have reacted negatively to the news with Abbott Labs'
share price falling 3.5% on the news.
Abbott Labs and Reata Pharma had announced the initiation of the
phase III study in mid-2011. The discontinuation of the BEACON
study is a huge disappointment for Abbott Labs, which remains on
track to split into two separate publicly traded companies from
January 1, 2013. One company will deal in diversified medical
products, while the other (AbbVie) will focus on research-based
Bardoxolene methyl was one of the most promising late-stage
candidates in AbbVie's pipeline. The CKD market represents
significant commercial potential with more than 26 million adults
affected in the US as per data from the National Kidney
Foundation. The successful development of bardoxolone methyl
would have helped reduce AbbVie's dependence on Humira for
Other late-stage candidates at Abbott Labs includes
levodopa-carbidopa intestinal gel (LCIG) for advanced Parkinson's
disease and daclizumab for the treatment of relapsing-remitting
multiple sclerosis (RRMS). Abbott Labs has partnered with
) for daclizumab.
We currently have a Neutral recommendation on Abbott Labs, which
carries a Zacks #3 Rank (short-term Hold rating).