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New Data From Large Safety Analysis of MYCAMINE Shows Favorable Clinical Safety Profile

Wednesday, September 19, 2007 General News J E 4
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CHICAGO, Sept. 18 New data from a pooled analysis of 17clinical studies demonstrate that MYCAMINE(R) (micafungin sodium) forinjection offers a favorable clinical safety profile in hospitalized patientsof all ages with serious, underlying diseases with immunosuppressed status.These studies, which represent the largest published safety data for anantifungal medicine to date, looked at more than 3,000 patients who receivedat 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 hada similar safety profile to fluconazole, caspofungin and liposomalamphotericin B. These data were presented today at the 47th AnnualInterscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

MYCAMINE is approved for the treatment of patients with esophagealcandidiasis and is the only echinocandin approved for the prophylaxis ofCandida infections and in patients undergoing hematopoietic stem celltransplantation.

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

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

"Astellas has a history of commitment to the development of medicines thatcan change the way healthcare providers treat infectious disease," said NkechiAzie, MD, Medical Director, Medical Sciences, Astellas. "We are proud to seethis number of micafungin studies at ICAAC and will continue to workcollectively in the anti-infective community toward optimal treatment optionsfor these patients."

Susceptibility Testing of Breakpoints with MYCAMINE

Results from multiple studies were presented at ICAAC, illustrating thebenefits of MYCAMINE in various populations and its activity as an antifungalagent. Of the presented abstracts, the following is noteworthy as the firstproposing susceptibility breakpoints of echinocandins, specifically MYCAMINE:

A Proposal for an Antifungal Susceptibility Testing (AST) Breakpoint ofMicafungin and Candida: Integration of AST Surveys and Correlation withClinical Outcomes

In this study, investigators looked at two large, well-known medicaldatabases to determine if candida isolates are more likely to be susceptibleor resistant when exposed to MYCAMINE. The survey included more than 400patients and 5700 isolates. The analysis found candida isolates are morelikely to be susceptible to MYCAMINE.

About the Safety Analysis

This pooled analysis included data from 17 clinical trials of MYCAMINEconducted between 1998 and 2006, and looked at 3,028 patients from all agegroups with severe and life-threatening underlying conditions, withapproximately half of patients undergoing transplants or being treated forcancer. Patients in clinical studies with MYCAMINE have complex underlyingconditions, such as cancer, HIV and hematopoetic stem cell transplantation andcomplications such as bacterial sepsis. Data are from 17 clinical studies inpatients who received at least a single dose of MYCAMINE.

Across all age groups, few adverse events were considered by theinvestigators to be treatment related, and no adverse events showed anincrease incidence with a longer duration of exposure to MYCAMINE. No trendswere seen
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