J&J's new data on Reminyl in mild cognative impairment shows higher death rates

Johnson & Johnson Pharmaceutical Research & Development says that health authorities are reviewing scientific data from two clinical trials evaluating an investigational use of the company's Alzheimer's treatment, Reminyl (galantamine hydrobromide), in individuals with mild cognitive impairment, which showed a higher incidence of deaths in this indication. The news sent the firm's share price 1.0% lower to $61.85 on January 21.

The drug, under co-development with the UK's Shire Pharmaceuticals, is an acetylcholinesterase inhibitor currently approved in 69 countries for the treatment of mild-to-moderate AD. No regulatory applications have been submitted for the potential use of Reminyl in the treatment of mild cognitive impairment anywhere in the world, nor are any planned, says J&JPRD.

The review was initiated as a result of a preliminary safety assessment of an imbalance of mortality in two mild cognitive impairment clinical trials submitted to health authorities worldwide by J&JPRD in August 2004. The clinical trial results were also presented last year at two international scientific forums: the International Congress of Alzheimer's Disease and the Alzheimer's Association Research Roundtable Mild Cognitive Impairment Meeting.