Napo Pharmaceuticals

crofelemer

CRO-HIV Indication: AIDS diarrhea, US and EU market

Napo is leveraging the significant clinical work which had been conducted by the previous sponsor of CRO-HIV. The product demonstrated activity in both a Phase 2 study and a large Phase 3 study.

Napo met with the FDA in 2004 and CRO-HIV received fast track status. In the pivotal Phase 3 ADVENT Study analyzed in late 2010, crofelemer demonstrated highly statistically significant results in the treatment of chronic diarrhea in people living with HIV/AIDS.

CRO-HIV product attributes summary:

• New Drug Application filed with FDA in December 2012
• Extensive pre-clinical and safety package
• No satisfactory alternative or competitive product approved for AIDS diarrhea indication in the US
• Multiple outside expert review of data and regulatory package