Valley Fever Drug Treatment Receives Fast-Track Designation by the FDA Under GAIN Act

Arizona Congressmen David Schweikert and Ron Barber were instrumental in helping AZBio Member Valley Fever Solutions receive Fast-Track Designation from the FDA for the potential curative anti-Valley Fever drug  nikkomycin Z (NikZ) as a “qualifying infectious disease product”  (QIDP) under the GAIN Act, which will help move it into clinical trials and eventually help patients.

Schweikert and Barber

Arizona Congressmen: Rep. David Schweikert (AZ-06) and Rep. Ron Barber (AZ-02)

Valley Fever Solutions, Inc. (VFS, an Arizona corporation), is developing Nikkomycin Z (NikZ) as a dramatically superior potential cure for Valley Fever. This is a painful and debilitating orphan disease causing over 2,000 serious cases and 150 deaths a year. About 60,000 people are sickened each year, suffering for months. Victims with more serious cases suffer for years.

“I think it has the potential of really changing this disease” shared Director of the UA Valley Fever Center for Excellence, Dr. John Galgiani .
“Current drugs don’t cure this disease. They’re valuable and we’re glad to have them, but they basically put the fungus to sleep rather than eradicating it and we hope that nikkomycin Z might change that and actually cure things,” (1)

The U.S. Food and Drug Administration (FDA) granted the potential curative anti-Valley Fever drug  nikkomycin Z (NikZ) as a “qualifying infectious disease product”  (QIDP) under the GAIN Act, which will help move it into clinical trials and eventually help patients.(2)

The QIDP designation is a provision of the GAIN Act, approved by Congress in 2012 to help provide incentives to produce new treatments for serious and orphan bacterial and fungal diseases.

Chairman of the Congressional Valley Fever Task Force, Rep. Kevin McCarthy (CA-23) and Co-Chairman, Rep. David Schweikert (AZ-06) successfully requested that Coccidioides species known to cause what is commonly referred to as Valley Fever be added to the list of Qualifying Pathogens under the GAIN Act.

In June 2014, the FDA added the underlying fungi species responsible for Valley Fever to the list of qualifying pathogens. By including Coccidioides on this list, FDA will give priority and expedited review to Valley Fever treatment and vaccine drug applications, as well as extend for 5 years the marketing exclusivity period for these products. These incentives will help promote the development of drugs to prevent or cure Valley Fever, which is prevalent across the American Southwest.(2)

Dr. John Galgiani, MD, Director of the University of Arizona’s Valley Fever Center for Excellence and David Larwood, President and CEO of Valley Fever Solutions, Inc. both spoke on the potential of NikZ at the Valley Fever Symposium held in Bakersfield, September 23-24, 2013. (2)

Congressional Valley Fever Task Force Co-Chair Congressman David Schweikert shared:

 “The continued development of the anti-Valley Fever drug Nikkomycin Z (NikZ) is a huge win. It will help all those who struggle with this disease and those fighting against it in the medical community on a daily basis.  I congratulate Dr. John Galgiani and his team at the University of Arizona on their relentless efforts to find a cure. I look forward to continued collaboration with the Valley Fever Task Force and organizations working to find ways to raise awareness of and ultimately beat this disease.” (2)

Congressman Ron Barber shared:

“Arizona is one of the most impacted regions by Valley Fever and I am proud that Dr. Galgiani and his team at the University of Arizona and Arizona company Valley Fever Solutions,Inc. are behind this important advancement. We have moved closer to a cure that will save lives and end this disease in our community.”

Congressional Valley Fever Task Force Chair Congressman McCarthy shared:

 “This is another important step forward in our fight against Valley Fever and I applaud the ongoing work of Dr. Galgiani and his team. He and David Larwood spoke of the potential of NikZ last September at our Valley Fever Symposium.  To see this potential cure moving forward shows how far we have come from working to raise awareness of Valley Fever to making strides to achieving our goal of erasing this disease from our communities.  I look forward to continue our work in collaboration with the FDA, CDC and NIH to combat this disease.” (2)

 David Larwood, President and CEO of Valley Fever Solutions, Inc. issued this statement:

“Bakersfield and Kern County have been leaders for decades in supporting efforts to treat and prevent Valley Fever. This QIDP designation builds on important contributions by the CSU Bakersfield Foundation in preserving the Nikkomycin-Z from Shaman Pharmaceuticals for transfer to the University of Arizona. As a Native Son of Kern County, I am proud to build on efforts in our community, and we thank the community for their continuing support.” (2)

In June of 2014, David Larwood shared insights into Valley Fever and the company’s work with Arizona’s life science community at the AZBio Expo in Scottsdale Arizona.  Below is a video of the presentation from AZBio.TV.  (3)

The company is currently seeking investors and strategic partners to move clinical trials forward faster.  (4)

Valley fever is common in the southwestern United States and clinical trials will have a direct benefit to Arizonans.

In the U.S., over 65 percent of all valley fever cases occur in Arizona, and 30 percent occur in California. Most other cases occur in Nevada, Utah, and New Mexico. Studies have shown that in some areas where valley fever is very common, such as southern Arizona, valley fever causes an estimated 15 percent to nearly 30 percent of all community-acquired pneumonias, but that less than 15 percent of patients with pneumonia symptoms are tested for valley fever. This suggests that there may be many more people with the disease than are reported. (5)

The Arizona Bioindustry Association  thanks Rep. Schweikert and Rep. Barber along with all of the members of the  Congressional Valley Fever Task Force for their leadership on this important initiative and for their dedicated efforts on behalf of the people of Arizona.




(2) Press Release from the office of Kevin McCarthy, Majority Leader, U.S. House of Representatives

(3) 2014 AZBio Expo Presentation by David Larwood, President & CEO, Valley Fever Solutions

(4) White Hat Life Science Investors Microsite – Passwords available to accredited investors. upon request

(5) CDC


Posted in AZBio News.