Pseudomonas Aeruginosa, Neisseria gonorrhoeae and Complicated Urinary Tract Infections

Credit: CDC

Credit: CDC

Overview: The emergence of multi-drug-resistant (i.e. cephalosporin-resistant) gram-negative bacterial infections like N. gonorrhoeae, E. coli, and P. aeruginosa have created a substantial need for the development of new therapies. As of 2010, ceftriaxone appears to be one of the few effective antibiotics left for treating multi-drug resistant infections with IV the only approved route of administration. Likewise, N. gonorrhoeae causes gonorrhea, the second most commonly reported sexually transmitted disease and a differential diagnosis to urinary tract infections. According to the CDC, an estimated 820,000 cases of the disease are contracted each year in the United States, of which 30% are resistant to existing antibiotics [7]. The disease can cause severe reproductive complications, including discharge and inflammation at the urethra, cervix, pharynx or rectum. Finally, P. aeruginosa causes significant nosocomial infections such as ventilator-associated pneumonia and various sepsis syndromes.

Potential Regulatory Benefits: Qualified Infectious Disease Product Exclusivity, Fast-Track, Accelerated Review.

Market: Treatment for gram negative infections is dominated by generic/branded 3rd generation cephalosporins like ceftriaxone, with newer approved 5th generation ceftolozane recently taking market share. Using sales estimates for these recent approvals as an analogue, the global market for an effective antibiotic for gram negative indications is expected to be $740 million per year. First in class antibacterials that can be administered in a single dose, that are safe and effective against drug-resistant gram-negative strains--including strains that are resistant to cephalosporins--with an oral step-down therapy would fit this criteria.