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RedHill Biopharma Reports Positive PK Clinical Studies Towards Planned NDA With RHB-102 (Anti-Emetic)

  • Following the positive results from two supportive pharmacokinetic (PK) studies, the Company plans to file a new drug application (NDA) in the first quarter of 2014 and is seeking a pre-NDA meeting with the FDA
  • RHB-102 is a proprietary, extended release, once-daily oral formulation of ondansetron, a leading drug for the prevention of nausea and vomiting in cancer patients
  • RHB-102 is one of RedHill's most advanced programs, along with RHB-103 (migraine) which has a PDUFA date of February 3, 2014, and RHB-104 (Crohn's) which recently commenced a Phase III study

TEL-AVIV, Israel, Oct. 8, 2013 (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 formulations and combinations of existing drugs, today reported positive results from two supplementary pharmacokinetic (PK) studies with RHB-102, an anti-emetic oncology-support drug.

The results of these studies are subject to final QA and an independent study report by the Canadian clinical research organization (CRO) which conducted the studies. The final independent report from the CRO is expected in the coming weeks.

RHB-102 is a patent protected, extended-release (24 hours) oral formulation of ondansetron, the active ingredient in GlaxoSmithKline's Zofran® immediate release tablets for the prevention of radiotherapy induced nausea and vomiting (RINV) and chemotherapy induced nausea and vomiting (CINV).

The Company believes that, if approved for marketing, RHB-102 will be the first and only once-daily oral ondansetron on the U.S. market at the time of approval. With clear potential advantages to cancer patients over the immediate release oral ondansetron tablets currently on the market, including the potential to enhance patient compliance and adherence thanks to increased convenience of use, RHB-102 is targeting a considerable segment of the 5-HT3 anti-emetic market, which was estimated to have worldwide sales of approximately $900 million in 2012 1.

The supplementary PK program was initiated by the Company in July 2013 to support the planned submission of a New Drug Application (NDA). Following the successful PK program, positive data generated from previous studies with RHB-102 and the Type B meeting held with the U.S. Food and Drug Administration (FDA) in February 2013, the Company is seeking a pre-NDA meeting with the FDA to discuss the clinical aspects of the planned NDA. Subject to the results of the pre-NDA meeting, completion of CMC (Chemistry, Manufacturing and Control) modules, and the required regulatory process, the Company plans to submit an NDA for RHB-102 in the first quarter of 2014, seeking U.S. marketing approval.

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