[Excerpt from press release, Accentia Pharmaceuticals]

Our first product candidate, SinuNase®, is an amphotericin B suspension
that is self-administered into a patient’s nasal cavity for the
treatment of chronic rhinosinusitis, or CRS. Rhinosinusitis is an
inflammatory condition of the paranasal sinuses that results in a
variety of symptoms, including nasal congestion, facial pain and
pressure, nasal discharge, and headaches....

In February 2004, we acquired a license from the Mayo Foundation for
Medical Education and Research that, as amended, gives us the exclusive
worldwide right to market and sell products based on Mayo Clinic’s
patented treatment method using amphotericin B. Mayo Foundation holds an
issued U.S. patent and a European Union counterpart patent application
covering the use of intranasal antifungals for the treatment of CRS. It
also holds a U.S. patent for the use of muco-administered antifungals
for the treatment of asthma, and in December 2004, we amended our
license with Mayo Foundation granting us rights to this therapy using
amphotericin B. Under our license, we are developing SinuNase as a
self-administered therapy delivered into the patient’s nasal cavity to
relieve the symptoms associated with CRS.

We elected to license amphotericin B for our CRS therapy as a result of
its favorable clinical and regulatory characteristics. To our knowledge,
it is the only intranasal antifungal used by Mayo Clinic or others in
their published studies on CRS, and amphotericin B is generally
recognized as being very unlikely to induce drug resistance among fungi.
As a fungicidal, amphotericin B is powerful enough to kill fungi, rather
than merely impair their growth. Also, amphotericin B, when applied
topically, has minimal absorption into a patient’s mucus membrane, which
makes it possible to apply an effective dose to the fungi in the mucus
with a low risk for systemic exposure to the patient. As an approved and
extensively-characterized therapeutic for other indications, we believe
the use of amphotericin B for our CRS therapy should provide for an
expedited regulatory approval process.

http://www.accentia.net/?page=sinunase