* Safety panel cites side effects, mortality
* Abbott shares fall 4.6 pct, day after AbbVie-related selloff
* Setback could increase AbbVie reliance on Humira
Oct 18 (Reuters) - Abbott Laboratories Inc said its partner Reata Pharmaceuticals was discontinuing a late-stage trial of their potential blockbuster treatment for chronic kidney disease and diabetes based on safety concerns raised by an independent safety committee.
The news for bardoxolone represents a major setback for Abbott just months before the planned Jan. 1 spinoff of its branded prescription drugs into a separate publicly traded company called AbbVie. Without the high-profile drug, Wall Street concerns about AbbVie’s dependence on Abbott’s $8 billion-a-year rheumatoid arthritis drug Humira could intensify.
An independent data monitoring committee found excess serious adverse events and mortality in patients taking the oral anti-inflammatory drug, Abbott said in a regulatory filing.
Regulators were notified of the decision, and study participants were being informed, the company said.
Shares of Abbott fell 4.6 percent in morning trading. The selloff follows similar stock declines on Wednesday after Abbott reported disappointing third-quarter sales of Humira and disclosed that AbbVie’s annual tax rate will be far higher than investors had expected, undermining AbbVie’s future earnings.
Cowen and Co had estimated bardoxolone could generate annual sales of more than $1 billion in the overseas territories where Abbott has rights to the drug, citing a potential market of 400,000 dialysis patients in Europe.
Reata in September 2010 granted Abbott exclusive rights to develop bardoxolone outside of the United States, excluding certain Asian markets.
Reata’s drugs are designed to activate Nrf2, a protein believed to be a principal regulator of cellular antioxidation and detoxification enzymes, while suppressing NFkB, a primary regulator of inflammatory genes.