Temple University is the original owner of the RHB-102 patents. Previously RedHill Biopharma had reported that Scolr Pharma, which originally licensed certain patents to RedHill Biopharma for RHB-102, ceased business operations.
Since Scolr Pharma had itself licensed those patents from Temple University, RedHill Biopharma has now licensed those same patents directly from Temple University under similar financial terms as the previous agreement with Scolr Pharma that has been terminated by RedHill Biopharma.
RedHill Biopharma has also announced that, following the completion of several previously-announced clinical studies, a pre-new drug application (NDA) meeting was held with the US Food and Drug Administration regarding RHB-102’s development for chemotherapy-induced nausea and vomiting (CINV) and radiotherapy-induced nausea and vomiting (RINV).
Following the pre-NDA meeting on RHB 102’s development for oncology support, the company has provided the FDA with additional information and is 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 Biopharma, in parallel to pursuing the CINV and RINV indications, is also pursuing a new indication for RHB-102. The company is planning a Phase III clinical study later 2014 in order to support the submission of an NDA targeting this additional new indication.
The company, in parallel to advancing the regulatory pathways in the US for multiple indications, also plans to submit a marketing authorization application later 2014 for RHB-102 in Europe for CINV and RINV.
RedHill is likely to conduct a comparative bioavailability study comparing RHB-102 to a European reference product ahead of submitting the marketing authorization application.