Israel based RedHill Biopharma Ltd. (RDHL) received positive news following the approval from the U.S. Food and Drug Administration (:FDA) to initiate a phase III trial on pipeline candidate RHB-102.
RHB-102 will be evaluated for the treatment of a new indication in the phase III study. The indication was not disclosed.
The double-blind placebo-controlled phase III study (n=320) will be conducted in eight clinical sites in the U.S. RedHill will start enrolling patients for the phase III study during the third quarter of 2014.
We remind investors that RedHill is also seeking approval of RHB-102 for the treatment of chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV respectively) in Europe and the U.S.
RedHill recently reported positive results from a comparative bioavailability study on RHB-102 for the treatment of migraines.
Based on positive results from the bioavailability study and data from prior successful clinical studies, RedHill now plans to submit a Marketing Authorization Application (MAA) in Europe for RHB-102 during the third quarter of 2014 for the treatment of CINV and RINV.
Earlier, in Mar 2014, RedHill held a pre-New Drug Application (pre-NDA) meeting with the FDA regarding the development of RHB-102 for CINV and RINV prevention in the U.S. RedHill has provided the FDA with additional information based on the feedback from the meeting and is currently awaiting the FDA's response.
Other interesting candidates in RedHill's pipeline includes – RHB104 for the treatment of Crohn’s disease (phase III), RHB-105 - an oral combination therapy for Helicobacter pylori infection (phase III study) and RHB-103 for acute migraines (NDA under review in the U.S.).
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