Reuters: Regulatory News: UPDATE 1-Baxter's Alzheimer's disease drug fails in late-stage trial

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UPDATE 1-Baxter's Alzheimer's disease drug fails in late-stage trial May 7th 2013, 12:12 Tue May 7, 2013 8:12am EDT * Baxter to stop developing drug for mild to moderate Alzheimer's * Drug failed to reduce decline of cognitive functions * Drug failed to preserve functional abilities of patients * Shares down 3 pct in premarket trading May 7 (Reuters) - Baxter International Inc said it will stop developing a drug for treating mild to moderate Alzheimer's disease after a late-stage study showed it failed to reduce the decline of cognitive functions and preserve functional abilities in patients. The trial showed that after 18 months of treatment, patients with mild to moderate Alzheimer's disease taking Baxter's immunoglobulin (IG) treatment did not show a statistically significant difference in the rate of cognitive decline compared to a placebo. The results also did not indicate a statistically significant change in patients' functional ability, Baxter said. Baxter shares were down 3 percent in premarket trading. They closed at $70.31 on the New York Stock Exchange on Monday. Based on the results, Baxter will reconsider its Alzheimer's program and will determine next steps after full data analyses, it said in a statement on Tuesday. "The study missed its primary endpoints. However we remain interested by the pre-specified sub-group analyses, particularly among patients with moderate disease and those who carry a genetic risk factor for Alzheimer's disease," Ludwig Hantson, president of Baxter's bioscience business, said in a statement. IG, already approved to treat primary immune deficiency, was well tolerated and no new safety signals associated with treatment in this patient population were identified. The most common adverse reactions were rash and decreases in hemoglobin. There were 17 serious adverse reactions considered to be treatment-related in the study. Alzheimer's is the leading cause of dementia that now affects some 5 million Americans and 38 million people worldwide. Link this Share this Digg this Email Reprints

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