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FDA grants Accentia Biopharmaceuticals...

Tampa, Fla. --Accentia Biopharmaceuticals, Inc. (Nasdaq:ABPI) has been notified that the U.S. Food and Drug Administration (FDA) granted Fast Track status to SinuNaseTM, the Company's intranasal Amphotericin B formulation. To the best of the Company's knowledge, SinuNase is the first and only drug candidate for chronic sinusitis (CS) to receive Fast Track status from the FDA.

Under the FDA Modernization Act of 1997, a new drug may be designated "Fast Track" provided the agency feels that the drug candidate has the potential to address unmet medical needs by treating serious or life-threatening conditions. With Fast Track status for SinuNase, Accentia is now eligible to submit a new drug license application (NDA) on a rolling basis, allowing the FDA to review sections of the NDA in advance of receiving Accentia's full submission, and permitting Accentia to apply for expedited review of its NDA.

Frank E. O'Donnell, Jr., M.D., Accentia's Chairman and CEO, commented: "Chronic sinusitis represents a substantial unmet clinical need, causing significant morbidity and expense. There is no approved pharmaceutical for the treatment of chronic sinusitis, despite 31 million affected patients in the U.S. alone, and about 500,000 patients who resort to sinus surgery each year in an attempt to control their chronic symptoms . These patients have chronic obstruction of the sinuses, which predisposes them to acute sinusitis, a bacterial super-infection for which more than 40 million antibiotic prescriptions are dispensed annually. The healthcare cost of chronic sinusitis is estimated at greater than $5 billion a year."

Accentia is preparing to commence its Phase 3 placebo-controlled clinical trial with SinuNase to treat post-surgical patients suffering from recurrent CS. The study is intended to be a four-month double-blinded comparison of symptomatic relief in patients randomized for treatment with either SinuNase or a placebo control.
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Contact: Adam Holdsworth
aholdsworth@investorrelationsgroup.com
212-825-3210
The Investor Relations Group
12-Apr-2006


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