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New Data From Large Safety Analysis of MYCAMINE Shows Favorable Clinical Safety Profile
Date:9/18/2007

More than 10 data presentations demonstrate the safety and activity of

MYCAMINE as an antifungal agent

CHICAGO, Sept. 18 /PRNewswire/ -- New data from a pooled analysis of 17 clinical studies demonstrate that MYCAMINE(R) (micafungin sodium) for injection offers a favorable clinical safety profile in hospitalized patients of all ages with serious, underlying diseases with immunosuppressed status. These studies, which represent the largest published safety data for an antifungal medicine to date, looked at more than 3,000 patients who received at least one dose of MYCAMINE, with median treatment lasting 18 days. Importantly, the investigators attribute few adverse events to treatments, even in longer periods of exposure. Comparative study data showed MYCAMINE had a similar safety profile to fluconazole, caspofungin and liposomal amphotericin B. These data were presented today at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

MYCAMINE is approved for the treatment of patients with esophageal candidiasis and is the only echinocandin approved for the prophylaxis of Candida infections and in patients undergoing hematopoietic stem cell transplantation.

"While current therapies may adequately treat many patients, drug safety is particularly critical in certain populations, particularly elderly patients," said Oliver Cornely, MD, University Hospital of Cologne, Germany. "These findings should be reassuring to physicians, in that they shed light on the safety and tolerability of MYCAMINE which has been studied more than any other echinocandin."

In addition to this analysis, 11 other MYCAMINE abstracts were accepted for presentation at this year's ICAAC meeting. When looked at together, the data provide further insight on MYCAMINE and its activity, demonstrating its value as an effective treatment for invasive fungal infections, compared to other drugs in its class.

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SOURCE Astellas Pharma US, Inc.
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