TEL-AVIV, Israel and RALEIGH, NC, USA I January 02, 2020 IRedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on commercialization and development of proprietary drugs for the treatment of gastrointestinal diseases, today announced that it has provided Salix Pharmaceuticals Ltd. (Salix) with a notice of termination of their 2014 license agreement and has regained the worldwide exclusive rights to RHB-106, a proprietary encapsulated formulation for bowel preparation, currently under development.

“We are pleased to regain the rights to RHB-106, which aligns well with our expanded gastrointestinal-focused commercial activities in the U.S., and to pursue its development toward potential U.S. FDA approval,” said Dror Ben-Asher, RedHill’s CEO. “The quality of a bowel preparation, defined by its safety, palatability and efficacy, directly impacts the success of a colonoscopy. We believe RHB-106’s novel flavorless solid oral pill formulation holds significant potential advantages over current bowel preparations and could ease patient burden and improve the likelihood of a successful outcome.”

It is estimated that approximately 19 million colonoscopies are performed annually in the U.S.1 The annual number of procedures in the U.S. is increasing, presumably due to the rising awareness of colorectal cancer. The 2019 sales of bowel preparations in the U.S. are estimated at approximately $580 million2.

About RHB-106
RHB-106 is a proprietary, flavorless, odorless, solid oral encapsulated formulation intended for the preparation and cleansing of the gastrointestinal tract prior to the performance of abdominal procedures and diagnostic tests, such as colonoscopies, barium enemas or virtual colonoscopies, as well as surgical interventions, such as laparotomies. RHB-106 can be taken with water and avoids patient exposure to the often unpalatable taste of current products. A Phase 2a study with a previous formulation of the RHB-106 actives was concluded in Australia with 62 patients demonstrating significantly improved patient response and comparable bowel cleansing, potentially allowing for an unobstructed procedure with reduced side-effects and improved compliance.

About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company, primarily focused on the commercialization and development of proprietary drugs for the treatment of gastrointestinal diseases. RedHill commercializes and promotes several gastrointestinal products in the U.S., Aemcolo®, Donnatal®, EnteraGam®, and Mytesi®, and is planning to launch Talicia® in the U.S. for the treatment of Helicobacter pylori (H. pylori) infection in adults3. RedHill’s key clinical late-stage development programs include: (i) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (ii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iii) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) ABC294640 (Yeliva®), a firstinclass SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 2a study for cholangiocarcinoma; (v) RHB106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at

SOURCE: RedHill Biopharma