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March 7, 2014
07:15 EDTRDHLRedHill Biopharma secures direct rights to original RHB-102 patents
RedHill Biopharma reported that it has secured direct rights from Temple University to the original RHB-102 patents, a once-daily oral formulation of the anti-emetic drug ondansetron. As previously reported by the company, SCOLR Pharma, which originally licensed certain patents to RedHill for RHB-102, announced that it had ceased business operations. Since SCOLR had itself licensed those patents from Temple University, the original owner of the patents, RedHill has now licensed those same patents directly from Temple University. The new licensing agreement with Temple University is under similar financial terms as the previous agreement with SCOLR, which has been terminated by RedHill. The company also reports that, following the completion of several previously-announces clinical studies, a pre-NDA meeting was held with the FDA regarding RHB-102's development for chemotherapy and radiotherapy-induced nausea and vomiting. Following the pre-NDA meeting, and in light of the FDA's feedback, RedHill provided the FDA with additional information and is currently awaiting the FDA's response. Given the ongoing discussions with the FDA, the company believes that the NDA for RHB-102 will not be submitted in the first quarter of 2014 as planned. RedHill will provide an update on the expected timeline for NDA submission of RHB-102 as soon as sufficient regulatory clarity is obtained, based on the outcome of the discussions with the FDA. In parallel to pursuing the CINV and RINV indications, RedHill is also pursuing a new indication for RHB-102. The company expects that, if approved by the FDA, the new indication would significantly expand the potential market for RHB-102. To support the submission of an NDA targeting this additional new indication, RedHill is planning a Phase III clinical study later this year. In parallel to advancing the regulatory pathways in the U.S. for multiple indications, RedHill also plans to submit, later this year, a Marketing Authorization Application for RHB-102 in Europe for CINV and RINV. RedHill plans to conduct a comparative bioavailability study comparing RHB-102 to a European reference product ahead of the MAA submission.
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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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