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RedHill Biopharma Announces Positive FDA Meeting on RHB-105 Path to Approval and Planned Confirmatory Phase III Study for H. pylori Infection

(GLOBE NEWSWIRE via COMTEX) -- - The FDA has confirmed, subject to final minutes of the meeting, the planned two-arm, randomized, double-blind, active comparator design of the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to be initiated in the second half of 2016

- Based on FDA feedback, and subject to successful completion, the planned confirmatory Phase III study, along with the successfully completed first Phase III study and data from a supportive PK program, are expected to support a U.S. New Drug Application (NDA) for RHB-105

- The first Phase III study with RHB-105 successfully demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105 (p<0.001), supporting the potential superior efficacy of RHB-105 over current standard-of-care (SoC) therapies

- RHB-105 has received FDA QIDP designation under the GAIN Act, including Fast-Track development, Priority Review and extended market exclusivity for a total of eight years

- With H. pylori infection estimated to affect over half of the adult population worldwide and increasing failure rates of SoC therapies due to antibiotic resistance, the 2015 global and U.S. market potential for H. pylori eradication therapies are estimated at approximately $4.83 billion and $1.45 billion, respectively

- RHB-105 is one of RedHill's three ongoing Phase III GI programs in the U.S., along with RHB-104 for Crohn's disease, with Phase III interim DSMB analysis expected in the second half of 2016, and BEKINDA(TM) for gastroenteritis, with Phase III top-line results also expected in the second half of 2016

TEL-AVIV, Israel, April 18, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. RDHL, +3.47% (tase:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced that it has concluded a positive Type B Meeting with the U.S. Food and Drug Administration (FDA) regarding the path to marketing approval of RHB-105 and the planned confirmatory Phase III study. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.

"We are very pleased with the outcome of the FDA meeting and would like to thank the Agency for its constructive feedback," said Gilead Raday, Chief Operating Officer. "The FDA meeting provided a pathway for potential marketing approval of RHB-105 in the U.S. We plan to initiate the RHB-105 confirmatory Phase III study discussed with the FDA during the second half of 2016 and hope to bring this new potential blockbuster drug to the market as soon as possible as a best-in-class, first-line therapy for eradication of H. pylori."

RedHill met with the FDA to discuss the successful results of the recently completed first Phase III study with RHB-105 (the ERADICATE Hp study) and the proposed design of the confirmatory Phase III study for the treatment of H. pylori infection. As a result of the productive and supportive feedback received from the FDA, RedHill intends, subject to finalization of the FDA meeting minutes, to complete the design of the planned confirmatory Phase III randomized, double-blind, active comparator, two-arm clinical study, comparing RHB-105 against a high dose amoxicillin and omeprazole regimen.

As per FDA recommendation, RedHill will complete a supportive pharmacokinetic (PK) program prior to initiating the confirmatory Phase III study in the second half of 2016. Subject to a successful outcome, the confirmatory Phase III study and supportive PK program are expected to complete the clinical package required for a U.S. New Drug Application (NDA) for RHB-105.

H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. H. pylori infection is estimated to affect over half of the adult population worldwide. The growing resistance of the H. pylori bacteria to metronidazole and clarithromycin has resulted in increasing failure rates of current standard-of-care therapies (SoC) for H. pylori...


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