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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.
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August 27, 2015
07:19 EDTRDHLRedHill receives notice of allowance for Israeli patent for Crohn's treatment
RedHill Biopharma announced that it has received a Notice of Allowance from the Israeli Patent Office for a new Israeli patent No. 207420 covering the formulation of RHB-104, a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. Once granted, the patent is expected to be valid through at least 2029. The new patent allowance in Israel further extends the geographic reach of RedHill's intellectual property for RHB-104 and is an addition to already granted U.S. patents and pending filings in other countries.
August 24, 2015
09:05 EDTRDHLRedHill reports peer-reviewed publication showing potential of ABC294640
RedHill Biopharma announced the publication of an article evaluating the therapeutic potential of ABC294640, the company's orally-administered first-in-class Sphingosine kinase 2, or SK2, selective inhibitor, in the treatment of prostate cancer. The article, authored by scientists from Apogee Biotechnology and from the Kimmel Cancer Center at Thomas Jefferson University, will be published in Molecular Cancer Research and is available online on the journal's website. RedHill acquired the rights to Yeliva in March from U.S.-based Apogee. RedHill has also filed a trademark application with the U.S. Patent and Trademark Office for the new brand name Yeliva for ABC294640. Subject to USPTO and FDA approval, the new brand name for the potential commercial product will beYeliva. The article1, entitled "Downregulation of Critical Oncogenes by the Selective SK2 Inhibitor ABC294640 Hinders Prostate Cancer Progression", describes a pre-clinical study conducted with Yeliva in early stage and advanced prostate cancer models. The findings from the study suggest that oral administration of ABC294640 disrupts multiple oncogenic signaling pathways that are deregulated in prostate cancer, corresponding with significant inhibition of tumor growth, proliferation and cell cycle progression. In particular, the compound inhibited in vitro several very resistant types of prostate cancer. The authors of the article conclude that these pre-clinical findings support the hypotheses that SK2 activity is required for prostate cancer function and that ABC294640 could represent a new pharmacological agent for the treatment of early stage and aggressive prostate cancer. The study was supported by a grant from the Pennsylvania Department of Health, a Prostate Cancer Foundation Young Investigator award, and a Prostate Cancer Foundation Mazzone Challenge award.

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