RedHill Biopharma updates development progress for RHB-102

February 25, 2013

RedHill Biopharma reported that it recently concluded a Type B meeting and has held additional communications with the FDA regarding RedHill's RHB-102, a patent protected, oral, extended-release formulation of ondansetron. Ondansetron is the active ingredient in GlaxoSmithKline's Zofran immediate release tablets for the prevention of radiotherapy induced nausea and vomiting, or RINV, and chemotherapy induced nausea and vomiting, or CINV. The purpose of these communications with the FDA was to discuss the filing of a U.S. NDA for RHB-102, following the company's 2012 comparative bioavailability study. Based on these communications and subject to additional regulatory and other activities, RedHill currently estimates that an NDA for RHB-102 will be filed during the fourth quarter of 2013. In the meantime, RedHill is focused on completing additional studies and product information required for the NDA data package and plans to seek additional regulatory guidance from the FDA ahead of the planned NDA submission.