Chronic sinusitis affects an estimated 31 million Americans. The symptoms are three or more months of chronic nasal obstruction, nasal discharge, and periocular headaches or pressure sensation. The symptoms of chronic inflammation could include the growth of inflammatory polyps in the nose, and recurrent bouts of acute bacterial sinusitis. There is no approved pharmaceutical for the indication of chronic sinusitis. Many patients with severe disease resort to sinus surgery in an attempt to relieve nasal obstruction and improve sinus drainage. The Mayo Clinic researchers have identified a ubiquitous air-borne fungus in the mucus of the nose and sinuses that elicits an inflammatory response in susceptible patients. Published studies at the Mayo Clinic and elsewhere have demonstrated a significant improvement in signs and symptoms of chronic sinusitis in patients treated with intranasal amphotericin B.
"We are working diligently to develop the Mayo patented technology for the treatment of chronic sinusitis with intranasal amphotericin B," said Steve Arikian, MD, President and COO of Accentia's Product Development and Market Services. "We recognized that our impending clinical trials of amphotericin B for this indication, if successful, would validate this discovery of the fungal cause of chronic rhinosinusitis. Accordingly, we wanted to be in a position to optimize our therapeutic franchise in this very large market which has no approved pharmaceutical."
In accordance with the Bayh-Dole Act of 1980, Mayo Clinic has licensed technology for the treatment of chronic rhinosinusitis with antifungals to Accentia and will receive royalties from the license.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology. Two of these products are SinuNaseTM and BiovaxID
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about this option agreement with Mayo, and any other statements relating to Accentia's products, product candidates, and product development programs. Such statement may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause Accentia's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of Accentia's clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in Accentia's filings with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
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