The BIO5 Institute at University of Arizona has obtained Orphan Drug status from the Food and Drug Administration for a promising treatment for valley fever, a lung disease that infects 150,000 new patients annually, many of them Arizonans.

Experimental studies have shown the drug, nikkomycin z, eradicating valley fever fungus in mice, but further clinical trials are required to determine if the drug will work in humans. The disease, known to researchers as coccidioidomycosis, is caused by fungal spores primarily found in desert soil.

UA's Valley Fever Center for Excellence, BIO5, and the Critical Path Institute (C-Path) have been working collectively to get the drug into such trials since acquiring it in 2005. It is hoped that gaining Orphan Drug status will help to move that process forward.

Passed in 1983, the Orphan Drug Act allows the federal government to assist in developing treatments for rare diseases, defined as diseases that affect fewer than 200,000 people per year. The program provides a number of practical benefits, including marketing exclusivity for seven years, tax credits for clinical development costs, fee waivers and regulatory guidance from the FDA, and grants for clinical studies.

"Tax credits and marketing exclusivity are two of the most important benefits at this stage of the development of nikkomycin z," said C-Path CEO and BIO5 faculty member Dr. Raymond Woosley. "If you can entice a drug company to develop the drug, no other company can produce or market the drug for the same purpose for seven years."

Orphan drug status can also open up opportunities for networking with investigators, potential commercial sponsors, funding sources, regulators, and patient groups.

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For more information:

"Valley fever cure a step closer," Arizona Republic, 04/12/2006

"UA's potential valley fever cure gets FDA boost," Tucson Citizen, 04/11/2006

BIO5 news release, 04/11/2006