RedHill Biopharma Announces Notice Of Allowance From The United States Patent And Trademark Office For Its Cardio Drug RHB-101

  • RHB-101 is a proprietary, controlled release, once-daily formulation of carvedilol for the treatment of hypertension, congestive heart failure and left ventricular dysfunction
  • The expected expiration date of the US patent is 2024

TEL-AVIV, Israel, Feb. 19, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill Biopharma"), 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 today that the United States Patent and Trademark Office ("USPTO") published a Notice of Allowance for RHB-101.

The USPTO has published the notification of a Notice of Allowance for U.S. Patent Application Serial Number 12/076,105 entitled "Controlled Release Carvedilol Compositions". This patent family has a priority date of November 8, 2002, and the U.S. patent, once granted, is not expected to expire until 2024.

RHB-101 is a once-daily, controlled release, proprietary formulation of carvedilol. Carvedilol is marketed under various trade names including GlaxoSmithKline's ("GSK") Coreg®. RHB-101 was licensed from the Danish company Egalet a/s in 2009. As carvedilol, RHB-101 is a β-adrenergic blocking agent with α1-blocking activity and is planned to be indicated for the treatment of hypertension, heart failure and left ventricular dysfunction. The Company is assessing RHB-101's development strategy, including its regulatory path, for marketing approvals in the U.S. pursuant to the 505(b)(2) regulatory path, and in Europe, based on clinical data generated in several pharmacokinetic (PK) trials.

RHB-101 entails several potential advantages over existing drugs on the market. One of the key advantages of RHB-101 is a once-daily administration regime, as oppose to generic drugs (such as GSK's Coreg®) which are administered to patients twice a day due to their relatively short active span. Administration once per day instead of several times per day has the potential to be a significant advantage, including improved compliance, especially for the elderly who commonly take a relatively large number of drugs over long periods of time. RHB-101 has also potential advantages over GSK's Coreg CR® - an improvement over the generic Coreg® drug, having a longer duration of action and being administered once per day.One of the potential advantages of RHB-101 over Coreg CR® is that RHB-101 is expected to be priced below the current price of Coreg CR®. Further potential advantages indicated by studies conducted to date consist of: (i) a reduced food effect on bioavailability, expected to allow patients to take RHB-101 with or without food while Coreg CR® is indicated to be taken with food and (ii) a markedly reduced dose.

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