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Published on 12/15/2005 in the Prospect News Biotech Daily.

Accentia, Mayo Clinic sign license option for sinusitis anti-fungals

By Angela McDaniels

Seattle, Dec. 15 - Accentia Biopharmaceuticals Inc. said it has signed an option agreement with the Mayo Foundation for Medical Education and Research for the exclusive right to negotiate a license for anti-fungals for the treatment of chronic sinusitis, sometimes known as chronic rhinosinusitis.

The option applies to a method of use for any and all anti-fungals other than amphotericin B applied intranasally. If unexercised, it will expire on Dec. 6, 2006.

Accentia has previously obtained a worldwide exclusive license for amphotericin B and is developing a unique formulation of the anti-fungal for intranasal application to treat chronic sinusitis under an Investigational New Drug Application, the company said.

"We are working diligently to develop the Mayo patented technology for the treatment of chronic sinusitis with intranasal amphotericin B," said Steve Arikian, president and chief operating officer of Accentia's product development and market services, in a company news release.

"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."

Chronic sinusitis affects an estimated 31 million Americans, the company said. The symptoms are three or more months of chronic nasal obstruction, nasal discharge and periocular headaches or pressure sensation.

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, the company said.

Accentia is a biopharmaceutical company based in Tampa, Fla., that develops late-stage clinical products in the therapeutic areas of respiratory disease and oncology.


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