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June 5, 2014
08:08 EDTRDHLRedHill Biopharma announces new RBH-104 patent in Japan
RedHill Biopharma reported that the Japan Patent Office has issued a Decision to Grant a Patent for a new patent covering RHB-104 in Japan. The patent is expected to be issued during 2014 and will have a 2029 expiry date. RHB-104 is a proprietary antibiotic combination oral capsule formulation for the treatment of Crohn's disease, currently undergoing a Phase III study in the U.S., Canada and Israel. RedHill further noted that it has initiated a long-term population pharmacokinetic study as part of the ongoing RHB-104 Phase III MAP US study. The Pop PK study, together with other supportive studies, including a recently completed food effect study, a drug-drug interaction study currently being reviewed and additional clinical and other studies, are designed to satisfy various regulatory requirements for future potential marketing applications of RHB-104. In addition to existing FDA clearance in the U.S., RedHill has received regulatory clearance to commence the Phase III MAP US study in Canadian and Israeli sites, and the first clinical sites in both countries have already initiated patient enrollment. As a result, there are currently 44 clinical sites in the U.S., Canada and Israel actively enrolling patients for the RHB-104 Phase III MAP US study. RedHill has increased the total number of planned clinical sites to up to approximately 90 sites in the U.S., Canada and Israel, and is planning additional clinical sites in other countries. RedHill is planning to commence a second Phase III study with RHB-104 for Crohn's disease in Europe following successful Scientific Advice Meetings with the UK and Swedish pharmaceutical regulatory agencies and discussions with key opinion leaders in Europe. The company is currently in the process of selecting a contract research organization for the MAP Europe study. Subject to receiving all the required regulatory approvals and other preparations, the MAP Europe study is planned to commence during the second half of this year.
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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