NanoBio Announces Development of Nasal Vaccine for the Prevention of Urinary Tract Infections in Collaboration with the Univers

NanoBio® Announces Development of Nasal Vaccine for the Prevention of Urinary Tract Infections in Collaboration with the University of Michigan

53 Percent of Women Suffer from UTIs Annually; Treatment and Evaluations Cost in Excess of $3.5B

ANN ARBOR, Mich. (April 20, 2011) - NanoBio Corporation today announced a licensing agreement with the University of Michigan that provides NanoBio with rights to an antigen that has been shown to prevent urinary tract infections (UTIs) following intranasal vaccination.

Through the agreement, NanoBio gains access to an antigen that University of Michigan researchers have shown can prevent recurring UTIs by eliminating E. coli bacteria in the urinary tract. The associated study involved immunizing mice intranasally with the antigen coupled with an adjuvant that is not approved for human use. To continue progressing toward a resolution for the millions of women who suffer from painful and often recurrent UTIs, a safe and effective vaccine is necessary.

NanoBio plans to pair the UTI antigen with the company's nanoemulsion-based NanoStat® adjuvant technology as the intranasal delivery mechanism for the vaccine. Once it is proven that the nanoemulsion-based vaccine achieves similar success in mice, it is anticipated that a human clinical trial will follow. The NanoStat adjuvant technology has been proven safe and effective in a previous clinical study of NanoBio's intranasal influenza vaccine.

According to the National Institute of Diabetes and Digestive and Kidney Diseases, 53 percent of women suffer from UTIs annually and nearly 500,000 are hospitalized as a result. Approximately one in five women who experience a UTI will have recurrent UTIs. Generally, UTIs are treated with a course of antibiotics to clear the infection; however, a clinically proven therapy for preventing UTIs is not available today. UTIs led to more than $3.5B in evaluation- and treatment-related costs in 2000.

"E. coli causes nearly 90 percent of all UTIs. It is a common bacterium and is frequently treated with antibiotics, which has led to the emergence of drug resistant strains that are difficult to treat," said Harry Mobley, Ph.D., The Frederick G. Novy Collegiate Professor of Microbiology and Immunology, and Chair and Professor, Department of Microbiology and Immunology, University of Michigan. "We previously anticipated at least ten years of further development of the vaccine before reaching commercialization; however, partnering with NanoBio and using their NanoStat technology will significantly accelerate the development of this long-awaited vaccine."

"Several attempts at developing a UTI vaccine have been unsuccessful as antibodies from blood have limited access to mucosal surfaces such as the urinary tract where these infections occur," said Ali I. Fattom, Ph.D., Senior Vice President Vaccine Research and Development, NanoBio. "We are confident the combination of effective UTI antigens with NanoBio's NanoStat adjuvant platform technology will result in strong mucosal immunity that can prevent these infections. We have recently shown in our influenza vaccine clinical studies that the NanoStat adjuvant is safe and mucosal immunity is enhanced significantly. These findings will facilitate the development of a safe and effective vaccine against mucosa-associated infections in the urinary tract."

About NanoBio

NanoBio® Corporation is a privately-held biopharmaceutical company focused on developing and commercializing dermatological products, anti-infective treatments and intranasal vaccines derived from its patented NanoStat® technology platform. The company's lead product candidates are treatments for herpes labialis (licensed to GSK in the U.S. and Canada), onychomycosis, acne, cystic fibrosis and a broad platform of intranasal vaccines. The company's headquarters and laboratory facilities are located in Ann Arbor, Michigan.