SinuNase IND on track

Accentia Biopharmaceuticals (Nasdaq: ABPI) was pleased to receive confirmation recently from the Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for the Company's proprietary drug SinuNase will remain under the direction of the Special Pathogens and Transplant Products (SPTP) section of the Centers for Drug Evaluation and Research (CEDR) of the Food and Drug Administration (FDA).

Accentia proposes to move forward with its first phase 3 study on recurrent post-surgical chronic sinusitis patients, and would like to include in its confirmatory phase 3 study additional patients who suffer from moderate to severe chronic sinusitis but have not had surgery, in order to seek an expanded label indication when the drug launches.

As a result of this determination that the IND will remain under the supervision of the Special Pathogens and Transplant Products section of the FDA, Accentia is consulting with that section on its development program for SinuNase, including whether or not it is advisable for the Company to resubmit an application for a special protocol assessment before commencing the first phase 3 study.

On Nov, 14, 2005 Accentia had disclosed that it had been notified by the FDA that its IND for SinuNase might be transferred to another division of the FDA, and the Company disclosed that it had voluntarily withdrawn its submission of a special protocol assessment agreement (SPA) for its first phase 3 study of SinuNase, pending resolution of the proposed transfer.

"A special protocol assessment identifies the exact label claim the clinical trial will support if successful, and it is specific to each phase 3 clinical study," explains Frank E. O'Donnell, Jr., M.D., Chairman and CEO of Accentia. "Both the Company and the FDA agree that statistically significant evidence showing that SinuNase precludes the need to resort to surgery to control severe chronic sinusitis would be beneficial, as th

Contact: Adam Holdsworth
The Investor Relations Group

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