Reminyl approved in USA for Alzheimer's

1 March 2001

Johnson & Johnson and Shire Pharmaceuticals have been given approval bythe US Food and Drug Administration for Reminyl (galantamine hydrobromide), their drug for the treatment of mild-to-moderate Alzheimer's disease. Shire co-developed Reminyl with J&J's Janssen Research Foundation subsidiary, and it is scheduled to be launched in May by two other J&J subsidiaries, Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical.

Reminyl will join existing Alzheimer's treatments such as Pfizer/Eisai's Aricept (donepezil) and Novartis' Exelon (rivastigmine) on the US market. Both the latter drugs inhibit acetylcholinesterase and are effective in augmenting memory and cognitive function but, unlike Reminyl, they have not been shown to have an impact on disease progression (Marketletter March 13, 2000). It is thought that Reminyl's dual mode of action, blocking acetylcholinesterase and stimulating nicotinic receptors, may be behind this finding, although US labeling for the drug makes no mention of this property.

Reminyl is now approved in 22 countries, including most major European markets, and analysts expect that it should be able to achieve peak sales of around $430 million a year. At the moment, Aricept is the market leader with global sales of around $650 million a year.

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