Clinical Trials

* On April 30, 2014, RedHill has reported positive results from a comparative bioavailability study with RHB-102, a proprietary, extended-release, once-daily oral pill formulation of the anti-emetic oncology support drug ondansetron for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting. The results of the study are subject to final quality assurance and an independent study report by the Canadian clinical research organization that conducted the study. The final independent report from the CRO is expected in the coming weeks. The two-arm crossover comparative bioavailability study conducted in Canada followed a positive European scientific advice meeting with the UK Medicines and Healthcare Products Regulatory Agency ("MHRA"), announced on April 7, 2014. The study, which included 20 healthy volunteers, was designed to support the planned European Marketing Authorization Application for RHB-102 and to explore the relative bioavailability between RHB-102 and GSK's European reference drug. The results of the study demonstrated that the exposure provided by RHB-102 supports its effectiveness and safety. In light of the positive results from the bioavailability study and data from prior successful clinical studies conducted with RHB-102, and subject to various regulatory requirements, RedHill plans to submit, during the third quarter of 2014, a European MAA for RHB-102 with the UK as the reference EU member state for the European Mutual Recognition Procedure. In parallel to pursuing the current indications in the U.S. and Europe, RedHill is also pursuing a new undisclosed indication for RHB-102. As previously announced, the Company has received guidance from the MHRA with regard to this additional indication, and is planning to commence a Phase III clinical study with RHB-102 in the U.S. later this year, to support a potential future submission of marketing applications in both the U.S. and Europe. RedHill expects that, if the Phase III clinical study in that new indication is successful, and the marketing applications are filed and approved, the new indication would significantly expand the potential market for RHB-102.

* On March 8, 2014, RedHill has announced that the company has secured direct rights from Temple University to the original RHB-102 patents, a once-daily oral formulation of the anti-emetic drug ondansetron. 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.

RedHill has also reported that, following the completion of several previously-announces clinical studies, a pre-New Drug Application ("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. 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 ("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.

* On July 11, 2013, RedHill Biopharma, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patentprotected, new formulations and combinations of existing drugs, has reported that it had commenced dosing in the first of two supplementary pharmacokinetic studies with RHB-102, a patent protected, oral, extended-release (24 hours) formulation of ondansetron.

The supplementary pharmacokinetic studies follow a Type B meeting held with the FDA in February 2013. The first pharmacokinetic study, conducted in Canada, includes 14 healthy volunteers and is intended to assess the effect of food on the absorption of RHB-102. The Company also plans to initiate, in August 2013, a supplementary comparative bioavailability clinical study with RHB-102, with Zofran® immediate release tablets as the reference drug. Based on the planned dosing schedule for the pharmacokinetic studies, the Company anticipates that the results of the studies will be available by October 2013. Subject to the results from the two studies and the required regulatory process, and in light of the data from prior successful studies with RHB-102, the Company plans to submit a New Drug Application (NDA) seeking U.S. marketing approval of RHB-102 in the first quarter of 2014, earlier than previously planned.

* On April 17, 2012, RedHill Biopharma has announced positive results in an advanced bioequivalence clinical trial with RHB-102 for the prevention of nausea and vomiting in cancer patients. RedHill intends to approach the FDA in the coming weeks to request a Pre-NDA meeting to discuss US marketing approval pathway. The draft final report summarizing the objectives and results of the trial demonstrates that the trial met its objectives and FDA's criteria for bioequivalence between RedHill's once daily RHB-102, and GSK's Zofran® - a leading, approved antiemetic drug administered three times per day.