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Health Authorities Reviewing Safety Data From Investigational Study Involving REMINYL(R) (Galantamine Hydrobromide)

Posted on: Friday, 21 January 2005, 15:00 CST

RARITAN, N.J., Jan. 21 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) announced today that health authorities are reviewing scientific data from two clinical trials evaluating an investigational use of the company's Alzheimer's treatment, REMINYL(R) (galantamine hydrobromide), in individuals with mild cognitive impairment.

REMINYL is an acetylcholinesterase inhibitor currently approved in 69 countries worldwide for treatment of mild to moderate Alzheimer's disease. No regulatory applications have been submitted for the potential use of REMINYL for the treatment of mild cognitive impairment anywhere in the world, nor are any planned.

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 also were presented last year at two international scientific forums: the International Congress of Alzheimer's Disease (ICAD) and the Alzheimer's Association Research Roundtable Mild Cognitive Impairment Meeting. J&JPRD has posted these results to the PhRMA clinical trials web site, http://www.clinicalstudyresults.org/.

Approximately 2,000 patients from 16 countries were enrolled in the GAL-INT-11 and GAL-INT-18 studies, which were designed to evaluate a potential decrease in the rate of progression from mild cognitive impairment to dementia in subjects treated with the drug.

Mortality rates were low in both the REMINYL and placebo groups in this two-year study compared to expected rates in this population or in patients with Alzheimer's disease. The clinical trials showed a higher relative mortality rate in patients with mild cognitive impairment treated with REMINYL than in patients treated with placebo. In the studies, 20 deaths due to various causes were reported during the double-blind portion of the two pivotal studies, with 15 occurring in subjects randomized to galantamine and five occurring in patients receiving placebo. The overall incidence of serious adverse events was not different between the REMINYL-treated group and the placebo-treated group.

J&JPRD is currently analyzing additional data from these studies, including information retrieved from subjects who had dropped out of the trials, and is discussing the results with regulatory authorities.

J&JPRD developed REMINYL under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. Janssen Pharmaceutica Products, L.P., manufactures and markets REMINYL in the U.S.

REMINYL is approved to treat patients with mild to moderate dementia of Alzheimer's. The most frequent adverse events are nausea, vomiting, diarrhea, anorexia and weight loss. They are usually mild and temporary. Please see http://www.reminyl.com/ for full prescribing information.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is part of Johnson & Johnson, the world's most broad-based producer of healthcare products. J&JPRD, with its headquarters in Raritan, New Jersey (USA), has nine sites throughout Europe and the United States. J&JPRD employs approximately 3,500 people and is leveraging drug discovery, drug evaluation, and drug development in a variety of therapeutic areas to address unmet medical needs worldwide. The company's major therapeutic areas of focus include hematology, oncology, infectious disease, obesity and metabolic disorders, neurology and psychiatry, pain and women's health.

Johnson & Johnson Pharmaceutical Research & Development, LLC

CONTACT: Media - Carol Goodrich of Johnson & Johnson, Office:+1-908-927-2014 or Mobile: +1-973-615-4057

Web site: http://www.clinicalstudyresults.org/

Source: PRNewswire-FirstCall

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