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RedHill Biopharma Initiates Phase III Study Of RHB-102 For Gastroenteritis

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  • The randomized, double-blind, placebo-controlled, parallel group Phase III study with RHB-102 (the GUARD study) will enroll 320 acute gastroenteritis patients in the U.S.
  • Acute gastroenteritis is an inflammation of the gastrointestinal tract causing nausea and vomiting, with a potential worldwide market estimated to exceed $650 million
  • If approved for marketing by the FDA, RHB-102 is expected to be the first-ever 5-HT3 antagonist drug indicated for acute gastroenteritis
  • Dr. Robert A. Silverman, MD, MS, Emergency Medicine specialist at the Hofstra North Shore-Long Island Jewish ("LIJ") Medical Center and Associate Professor at the Hofstra North Shore-LIJ School of Medicine will act as the lead investigator for the GUARD study
  • RedHill is focused on inflammatory and gastrointestinal ("GI") diseases, including GI cancers, and is currently conducting three Phase III GI studies in the U.S., including the RHB-102 GUARD study for gastroenteritis, the RHB-104 MAP US study for Crohn's disease and the RHB-105 ERADICATE Hp study for H. pylori infection

RedHill Biopharma Ltd. (Nasdaq: RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that it is initiating a Phase III clinical study designed to evaluate the safety and efficacy of RHB-102 in patients suffering from acute gastroenteritis, an inflammation of the gastrointestinal tract which causes, among other symptoms, nausea and vomiting. RHB-102 is a proprietary, oral, extended-release, once-daily formulation of the antiemetic drug ondansetron.

Acute gastroenteritis is an inflammation of the mucus membranes of the gastrointestinal tract, most commonly caused by a viral infection. Symptoms of gastroenteritis include nausea, vomiting, diarrhea and abdominal pain. With over 179 million cases annually in the U.S. alone1, the worldwide potential market could exceed $650 million annually2.

The randomized, double-blind, placebo-controlled, parallel group Phase III study will be conducted in up to 10 clinical sites in the U.S. and is expected to enroll 320 adults and children over the age of 12 who suffer from acute gastroenteritis. Patients will be randomized to receive either RHB-102 or a placebo. The primary endpoint for the study is the absence of vomiting from 30 minutes after the first dose through the discharge from the emergency department. Secondary endpoints include frequency of vomiting, severity and time to resolution of nausea, and time to resumption of normal activities. Top-line results from the RHB-102 Phase III GUARD study are expected during the second half of 2015.

Following prior discussions with the U.S. Food and Drug Administration ("FDA") and the UK Medicines and Healthcare Products Regulatory Agency ("MHRA"), the GUARD study is intended to support potential future submissions of marketing applications in both the U.S. and Europe for this indication. If approved for marketing by the FDA, RHB-102 could become the first-ever 5-HT3 antiemetic drug indicated for the treatment of acute gastroenteritis.

Dr. Robert A. Silverman, MD, MS, RHB-102 GUARD Phase III study lead investigator, said: "I am very pleased to take part in this important study in which we will assess the efficacy of RHB-102 in patients presenting to the hospital emergency room with acute gastroenteritis. If approved, RHB-102 could potentially decrease the number of emergency room visits of patients suffering from acute gastroenteritis by offering them a long-lasting oral treatment which can be taken in the comfort of their home."

Dr. Reza Fathi, RedHill's Senior VP Research and Development, added: "The GUARD study with RHB-102 for acute gastroenteritis further establishes RedHill's focus on gastrointestinal and inflammatory diseases and expands the Company's reach into this high unmet-need therapeutic space. It is the third GI-focused Phase III study that RedHill is currently conducting in the U.S., along with the RHB-104 MAP US study for Crohn's disease and the RHB-105 ERADICATE Hp study for H. pylori infection."

Ondansetron, a 5-HT3 antagonist and the active pharmaceutical ingredient in RHB-102, has been approved in the U.S. and Europe, in oral immediate release and non-oral forms, for the prevention and treatment of chemotherapy and radiotherapy-induced nausea and vomiting. No formulation of ondansetron or any other 5-HT3 antagonist has been approved by the FDA for the treatment of gastroenteritis. RHB-102 is a proprietary, extended-release (24 hours), oral pill formulation of ondansetron.

In parallel to the Phase III study for gastroenteritis, RedHill is pursuing marketing approval of RHB-102 for the indications of chemotherapy-induced and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively) in the U.S. and Europe. Following a positive European scientific advice meeting with the UK's MHRA, and a successful comparative bioavailability study comparing RHB-102 to a European reference drug, RedHill plans to submit a European Marketing Authorization Application for RHB-102 by October 2014 for the indications of CINV and RINV prevention. RedHill has also held a pre-New Drug Application (pre-NDA) meeting with the FDA regarding the development of RHB-102 for CINV and RINV prevention in the U.S. Following the pre-NDA meeting and in light of the FDA's feedback, RedHill provided the FDA with additional information and is currently awaiting the FDA's response.

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