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RHEI Pharmaceuticals Announces the Initiation of the Final Clinical Study for Approval of Tibozole in China
Date:12/5/2008

New Product will Fill Void in the Local Treatment of Oral Candidiasis in Immunosuppressed Patients in China

PLAINSBORO, N.J., Dec. 5 /PRNewswire/ -- RHEI Pharmaceuticals, Inc. today announced that the final clinical trial for Tibozole, a locally active antifungal with low dose miconazole in a patented mucoadhesive system, has been initiated in China. This will be the last clinical trial conducted for submission of the New Drug Application (NDA) to the State Food and Drug Administration (SFDA) in China. RHEI licensed Tibozole from Tibotec, a Johnson and Johnson company.

This study will compare Tibozole to Sporanox (itraconazole) and include approximately 350 patients who have oral candidiasis. Patients will be treated once daily for a maximum of 14 days. The endpoint is clinical and mycological cure. The study is expected to continue through most of 2009, with an expected NDA filing in China toward the end of next year.

"If and when approved, Tibozole will be the first local azole treatment in the Chinese market for oral candidiasis," said Dr. Geert Cauwenbergh, Chief Executive Officer and Chairman of RHEI Pharmaceuticals. "Although very effective, systemic drugs can have systemic side effects and drug interactions in certain patients, like those with cancer or AIDS, who are often on multiple other therapies. Tibozole, a locally active azole derivative in a patented slow release mucoadhesive system, will be a welcome alternative when systemic absorption could create issues in patients."

About Oral Candidiasis

Oral candidiasis, which is sometimes called thrush, is a fungal infection of the mouth and/or throat caused by Candida albicans, although other related Candida may be involved. It appears as thick white or cream-colored deposits on mucosal membranes. The infected mucosa of the mouth may appear
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SOURCE RHEI Pharmaceuticals, Inc.
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