Accentia Biopharmaceuticals Announces Results on Primary Endpoint in Clinical Study of SinuNase Lavage

Business Wire, March 24, 2008

TAMPA, Fla. -- Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) today announced that its Phase 3 clinical trial evaluating the Company's exclusively-licensed technology from the Mayo Clinic consisting of an intranasal antifungal lavage, SinuNase[TM] (topical amphotericin B 0.01% suspension) achieved, as anticipated, superior resolution of the cardinal symptoms of chronic sinusitis (CS), as compared to placebo control arm, however, the analysis of the unblinded primary endpoint data did not show the required level of statistical significance when comparing the SinuNase arm to the control arm.

The unblinded intent-to-treat (ITT) statistical analysis using the O'Brien composite ranking showed a p-value = 0.14 comparing SinuNase lavage to the control lavage. The Company continues to believe that SinuNase is a viable product candidate for the treatment of CS, and a full data analysis of both the primary and secondary endpoints will be conducted in order to determine the next steps necessary in order to advance the product, both in its lavage and pump-spray formulations.