RedHill Biopharma Provides 2017 Semi-Annual Business Update

- 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

- 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 be initiated in the fourth quarter of 2017

- Re-submission of the NDA for RIZAPORT® for acute migraines is expected in October 2017

TEL-AVIV, Israel and RALEIGH, N.C., Aug. 10, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today provided an update on key programs, potential milestones and estimated timelines.

Dror Ben-Asher, Chief Executive Officer of RedHill, said: “RedHill has transitioned into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company, as we continue to pursue important clinical development milestones in the near future. I would like to thank the RedHill team for their meaningful achievements on the R&D and commercial fronts thus far in 2017.”

Source : RedHill Biopharma Ltd.