This shows VERY HIGH POTENTIAL.
Attached please find RedHill Biopharma's 2017 semi-annual business update on key programs, potential milestones and estimated timelines.
· RedHill’s U.S. gastrointestinal (GI)-focused sales force is promoting two specialty products, setting the stage for the potential launch of RedHill’s late clinical-stage GI products, if approved, and for the acquisition of additional commercial GI products
· The ERADICATE Hp2 confirmatory Phase III study with TALICIA™ (RHB-105) for H. pylori bacterial infection is ongoing; TALICIA™ was granted QIDP designation by the FDA, allowing for Fast-Track status and Priority Review, potentially leading to a shorter NDA review time by the FDA, and, if approved, an additional five years of U.S. market exclusivity on top of the standard exclusivity period
· Following a unanimous positive DSMB recommendation, the Phase III MAP US study with RHB-104 for Crohn’s disease is continuing as planned; An open-label extension Phase III study (the MAP US2 study) is ongoing in parallel
· Following positive top-line results from the Phase III study with BEKINDA® 24 mg for acute gastroenteritis, the outcome of the planned FDA Type B meeting to discuss the potential path to marketing approval is expected to be announced in October 2017
· Top-line results from the Phase II study with BEKINDA® 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) are expected in September 2017
· In light of recent FDA guidance on the potential path to marketing approval of RHB-104 as first-line therapy for nontuberculous mycobacteria (NTM) infections, RedHill plans, subject to regulatory approvals, to initiate a pivotal Phase III study in the U.S. with RHB-104 for NTM infections in the first quarter of 2018; RHB-104 was granted QIDP designation by the FDA for the treatment of NTM infections
· In light of encouraging results from prior non-clinical studies, an NIAID Safety Committee recently approved a planned proof-of-concept study to evaluate RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease; The study is expected to initiate in the fourth quarter of 2017
· Re-submission of the NDA for RIZAPORT® for acute migraines is expected in October 2017
