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[DewDiligence]

Neurochem says Fibrillex failed to meet study goal

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh65054_2005-04-18_12-09-47_n18...

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CHICAGO, April 18 (Reuters) - Neurochem Inc. ( NRMX ) on Monday said a clinical trial of its experimental drug Fibrillex to treat a disease that normally leads to renal failure did not meet its primary goals.

The stock fell 28 percent to $8 in pre-market activity on the Inet system from Friday's close of $11.07 on Nasdaq.

Neurochem said the study showed Fibrillex, for the treatment of AA amyloidosis, is well tolerated, and it will continue with plans to seek regulatory approval for the drug.

Primary endpoints of the phase II/III clinical trial included kidney function measurements and called for a 20 percent difference in the number of patients who improved on the drug compared with a placebo.

Results of the trial, involving 183 patients treated for 24 months, showed 13.4 percent more patients remained stable or improved on Fibrillex.

AA amyloidosis is a progressive and fatal condition that can occur in patients with inflammatory diseases such as rheumatoid arthritis and Crohn's disease.

Neurochem said it plans to complete its analysis of the study data and present it to the U.S. Food and Drug Administration as soon as possible. It also plans to present data at international medical conferences in the first half of 2005.

The company said it will continue to supply Fibrillex to any patient who received the drug through the study.

Fibrillex has already received orphan drug status in the United States and orphan medicinal product designation in Europe.
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