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May 22, 2014
08:20 EDTRDHLRedHill Biopharma announces FDA clearance for Phase III study with RHB-102
RedHill Biopharma announced that the FDA has allowed the initiation of the company's planned Phase III clinical study for the treatment of a new, undisclosed indication with RHB-102, an extended release oral pill formulation of the antiemetic drug ondansetron. RedHill plans to begin enrolling patients for the Phase III study during Q3. The double-blind placebo-controlled Phase III study is planned to be conducted in eight clinical sites in the U.S. and will include 320 subjects. Based on prior discussions with the FDA and the UK Medicines and Healthcare Products Regulatory Agency, or MHRA, the study is intended to support potential future submissions of marketing applications for a new undisclosed indication in both the U.S. and Europe. RedHill estimates that, if the Phase III clinical study is successful and the marketing applications are filed and approved by the FDA and the MHRA, the new indication would significantly expand the potential market for RHB-102. In parallel to pursuing the new undisclosed indication, RedHill is pursuing marketing approval of RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting in Europe and the U.S.
News For RDHL From The Last 14 Days
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July 29, 2015
06:17 EDTRDHLRedHill Biopharma reports Q2 EPS (7c), consensus (46c)
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July 27, 2015
07:12 EDTRDHLRedHill Biopharma provides update on RHB-106 program
RedHill Biopharma (RDHL) provided an update on its RHB-106 tasteless solid oral formulation bowel preparation development program under the worldwide exclusive license agreement with Salix Pharmaceuticals, recently acquired by Valeant Pharmaceuticals International (VRX). Salix confirmed to RedHill that it continues the development of RHB-106. Salix further clarified to RedHill that the bowel purgative product referenced in Valeant's Q2 financial results presentation1 as a failed toxicology screen is not RedHill's RHB-106. On February 27, 2014, RedHill and Salix entered into an exclusive license agreement under which Salix acquired the worldwide exclusive rights to RedHill's RHB-106 encapsulated formulation for bowel preparation and rights to other purgative developments. Financial terms of the transaction included an upfront payment to RedHill of $7M, and an additional $5M in subsequent milestone payments to RedHill. Salix also agreed to pay RedHill tiered royalties on net sales, ranging from low single digits up to low double digits. RHB-106 is an encapsulated formulation intended for the preparation and cleansing of the gastrointestinal tract prior to the performance of abdominal procedures, including diagnostic tests such as colonoscopies, barium enemas or virtual colonoscopies, as well as surgical interventions, such as laparotomies. RHB-106 is a tasteless solid oral dosage potentially allowing an unobstructed procedure with reduced side effects and improved compliance. It is also intended to prevent patient exposure to the often unappealing taste of current products.

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