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RedHill Biopharma Announces Positive FDA Meeting Regarding The Regulatory Path Towards NDA Submission Of RHB-101 For The Treatment Of Congestive Heart Failure And Hypertension

  • Following the prior successful completion of four pharmacokinetic (PK) clinical studies, the Company held a Type B meeting regarding RHB-101 with the U.S. Food and Drug Administration (FDA)
  • Based on the FDA's positive feedback, the Company plans to conduct additional Chemistry, Manufacturing, and Controls (CMC) and PK work prior to submission of a New Drug Application (NDA) of RHB-101
  • The Company also plans to conduct CMC work prior to submission of a Marketing Authorization Application (MAA) to market RHB-101 in Europe, with Denmark as the reference member state for the European Mutual Recognition Procedure (MRP)
  • On May 28, 2013, the United States Patent and Trademark Office (USPTO) issued a new patent covering RHB-101 entitled "Controlled release carvedilol compositions," which expires no earlier than 2024

TEL-AVIV, Israel, May 29, 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, patent-protected, new formulations and combinations of existing drugs, reported that it recently concluded a positive Type B meeting with the U.S. Food and Drug Administration (FDA) regarding its cardio drug RHB-101, a controlled release, proprietary, once-daily formulation of carvedilol, for the treatment of congestive heart failure and hypertension.

Following the positive FDA meeting, the Company plans to submit a New Drug Application (NDA) seeking marketing approval of RHB-101 in the U.S. Based on the FDA's feedback, prior to the NDA submission, the Company plans to conduct additional Chemistry, Manufacturing, and Controls (CMC) work and to conduct a comparative bioavailability study and a dose linearity study.

The planned single dose comparative bioavailability study versus Coreg CR ® (the branded controlled release carvedilol marketed by GSK in the U.S.) is intended to assess the comparability of RHB-101 pharmacokinetics to Coreg CR ® and follows the prior successful completion of four pharmacokinetic (PK) clinical trials comparing RHB-101 to Eucardic ® (the branded immediate release carvedilol marketed by Roche in Europe, equivalent to Coreg ®).

Following positive results in a recent meeting held with the Danish Health and Medicines Authority (DKMA), the Company plans to submit a Marketing Authorization Application (MAA) in Europe for RHB-101, with Denmark as the reference member state for the European Mutual Recognition Procedure (MRP). Based on the response in the official minutes of the meeting with the DKMA, RedHill believes that, while additional CMC work is required, no further clinical studies will be required prior to submission of the MAA.

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