- RHB-102 is a proprietary once-daily oral antiemetic
- RedHill has secured from Temple University direct rights to the original RHB-102 patents and has terminated its agreement with SCOLR Pharma Inc.
- Following a pre-NDA meeting on RHB 102's development for oncology support, RedHill has provided the FDA with additional information and is awaiting the FDA's response
- In addition to the currently pursued indications, the Company is pursuing a new indication for RHB-102, with a Phase III study planned later this year, significantly expanding RHB-102's potential market
- In parallel to the U.S. regulatory pathway, RedHill plans to seek marketing approval of RHB-102 in Europe for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting
TEL-AVIV, Israel, March 7, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, today 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 Inc. ("SCOLR"), 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-New Drug Application ("NDA") meeting was held with the U.S. Food and Drug Administration ("FDA") regarding RHB-102's development for chemotherapy and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively). 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.