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06/12/14 - $680.00
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redhill biopharma ltd (RDHL) Details

RedHill Biopharma Ltd. is an Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. Its pipeline of proprietary products includes: RHB-104, an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study; RHB-105, an oral combination therapy for Helicobacter pylori infection, with an ongoing Phase III study; and RHB-102, a once-daily oral pill formulation of ondansetron for the prevention of nausea and vomiting in advanced stages of development for multiple indications. In addition, the company’s product pipeline includes RHB-106, an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals, Ltd.; MESUPRON, a Phase II-stage uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; RP101, a Phase II-stage Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; RHB-103, an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review; and RHB-101, a once-daily oral pill formulation of the cardio drug carvedilol. RedHill Biopharma Ltd. was founded in 2009 and is based in Tel Aviv, Israel.

8 Employees
Last Reported Date: 02/25/14
Founded in 2009

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redhill biopharma ltd (RDHL) Key Developments

RedHill Biopharma Ltd. Provides Update on Progress with RHB-104 Ongoing Phase III Program for Crohn's Disease

RedHill Biopharma Ltd. provided an update on the progress with the ongoing RHB-104 Phase III development program for the treatment of Crohn's disease. The Company, together with Quest Diagnostics, recently concluded a pre-submission meeting with the FDA regarding the development path of a commercial companion diagnostic test for the detection of Mycobacterium avium subspecies paratuberculosis (MAP) in Crohn's disease patients. Following the constructive FDA meeting, RedHill intends to initiate a study of approximately 40 Crohn's disease patients to assess the clinical utility of the companion diagnostic test during the second or third quarter of 2015. RedHill is collaborating with Quest Diagnostics for the development of the potential companion diagnostic test, which is an extension of RedHill's development program for the Company's Crohn's disease drug, RHB-104, currently undergoing a first Phase III study (the MAP US study). RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties. The development of RHB-104 and the MAP companion diagnostic test is based on increasing evidence supporting the hypothesis that Crohn's disease is caused by MAP infection in susceptible patients. RedHill previously announced that it acquired the rights to patented technologies from the University of Minnesota and the University of Central Florida to support the development of this diagnostic test. There is currently no validated, FDA-approved, commercially available method of detecting the presence or absence of MAP in patients suffering from Crohn's disease and other diseases. RedHill further announced that a protocol amendment has been filed with the FDA to the approved IND in relation to the ongoing Phase III MAP US study with RHB-104 for the treatment of Crohn's disease. As part of the amendment, the number of subjects planned to be enrolled in the study has been increased from 240 to 270 in order to account for potential drop-outs from the study. Additionally, the amendment allows for the inclusion of Crohn's disease patients with moderate to severe disease despite current treatment with anti-Tumor Necrosis Factor (anti-TNF) therapies infliximab (Remicade) and adalimumab (Humira). The inclusion of these concomitant medications significantly increases the number of Crohn's disease patients potentially eligible to enroll in the ongoing Phase III MAP US study. With 66 clinical sites actively enrolling patients, RedHill also plans to increase the number of clinical sites in the Phase III MAP US study, currently ongoing in the U.S., Canada and Israel, from 100 to 120, including new sites in Australia, New Zealand and Europe.

RedHill Biopharma Ltd. Presents at 8th Annual OneMedForum 2015, Jan-12-2015

RedHill Biopharma Ltd. Presents at 8th Annual OneMedForum 2015, Jan-12-2015 . Venue: San Francisco Marriott Marquis, Parc 55 Wyndham, Union Square, San Francisco, California, United States.

RedHill Biopharma Ltd. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-12-2015

RedHill Biopharma Ltd. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-12-2015 . Venue: Westin St. Francis Hotel, San Francisco, California, United States.


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