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news.Accentia Biopharmaceuticals has gained an exclusive worldwide license from the Mayo Clinic for non-prescription products for the treatment of symptoms associated with chronic sinusitis. As part of the licensing deal, Accentia has also gained the right to proceed with commercialization of the first product.
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The new agreement, which expands a previous deal, is for all of the Mayo Clinic’s non-prescription intranasal treatments for the condition which work by suppressing non-invasive (so-called “saprophytic”) fungi in the mucus of patients.
“Published research at the Mayo Clinic has demonstrated that a specific common airborne mold seems to be responsible for the majority of cases of chronic sinusitis. The mold is non-invasive, meaning that it is in the mucus rather than in the tissue. The mold is present in the mucus of virtually everyone, but in patients with chronic sinusitis, the mold elicits an inflammatory response from the host,” said Dr Frank O’Donnell, chairman and CEO of Accentia.
Accentia previously obtained a worldwide exclusive license from the Mayo Clinic for SinuNase, whose active ingredient is the prescription antifungal amphotericin B. The company is developing SinuNase as a prescription intranasal formulation for moderate to severe cases of chronic sinusitis (CS).
Accentia received fast track status for SinuNase from the FDA and is in the process of commencing phase III clinical trials in patients with CS refractory to surgery.
According to the company, CS, also known as chronic rhinosinusitis (CRS), is one of the most common diseases suffered by Americans today, affecting an estimated 31 million patients in the US. Patients often get recurrent bouts of acute bacterial sinusitis characterized by fever, malaise, pain and which require treatments with oral, systemic antibiotics.