RedHill Secures Direct Rights To Original RHB-102 Patents - Quick Facts

(RTTNews) - RedHill Biopharma Ltd. (RDHL) said 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., 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 said that, following the completion of several previously-announces clinical studies, a pre-New Drug Application or "NDA" meeting was held with the U.S. Food and Drug Administration or "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.

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 addition, RedHill also plans to submit, later this year, a Marketing Authorization Application or "MAA" 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.