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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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December 18, 2014
06:18 EDTRDHLRedHill Biopharma acquires techonology from University of Minnesota
RedHill Biopharma (RDHL) has entered into a license agreement with the University of Minnesota to acquire the rights to a patented technology to support the development of a commercial diagnostic test for detection of Mycobacterium avium subspecies paratuberculosis bacterium. RedHill's Crohn's disease program RHB-104, currently undergoing a first Phase III study, is based on evidence that Crohn's disease is caused by MAP infection in susceptible patients. As part of development for RHB-104, RedHill is developing, in collaboration with Quest Diagnostics (DGX), a diagnostic test to aid in detecting the presence of MAP in whole blood. RedHill will pay the University of Minnesota a one-time upfront payment and an additional potential milestone payment for the licensed technology. A pre-submission meeting with the FDA to discuss the development path for the diagnostic test is scheduled for January 2015.
December 17, 2014
06:14 EDTRDHLRedHill Biopharma enrolls first patients in Phase III study of RHB-102
Red Hill announced that the randomized, double-blind, placebo-controlled Phase III study with RHB-102 for acute gastroenteritis and gastritis is underway in the U.S., with a planned enrollment of 320 patients. Top-line results from the Phase III GUARD study are expected during 2H15. RedHill recently submitted a European Marketing Authorization Application seeking approval of RHB-102 for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting. Results are intended to support potential future submissions of marketing applications in both the U.S. and Europe for this indication. In parallel, RedHill is pursuing marketing approval for RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting in Europe and the U.S.

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