The amendment extends the exclusive option agreement an additional year and will expire on December 6, 2007 beyond the anticipated date of a new drug application (NDA) filing for SinuNase. Accentia is developing SinuNase under an exclusive worldwide license with the Mayo Clinic for the use of intranasal amphotericin B for refractory chronic sinusitis.
From the date of the amendment’s signing until the expiration of the contract in 2007, Accentia has the exclusive option to license any and all antifungals, including prescription and non-prescription or over-the-counter intranasal products.
“The extension of this exclusive licensing option agreement beyond the anticipated filing date of our NDA is a positive step forward for Accentia, as we continue our development of SinuNase,” said Dr Frank O’Donnell, Jr., Accentia chairman and CEO. “SinuNase has received fast track status from the FDA and is the first and only drug to ever reach the final phase (phase III) of clinical trials for chronic sinusitis.”