RedHill Biopharma Announces Notice of Allowance From the United States Patent and Trademark Office for Its Cardio Drug RHB-101

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.

The worldwide target market of RHB-101 was estimated to be in excess of $500
million in 2011^[1].

"We are very pleased with this Notice of Allowance which serves as an
indication of yet another important layer of intellectual property protection
for RHB-101, our controlled release formulation of carvedilol", said Guy
Goldberg, RedHill's Chief Business Officer. "We continue to move ahead with
the development plan for RHB-101, which is aimed at improving existing
treatments for patients suffering from hypertension, heart failure and left
ventricular dysfunction, while exploring potential paths for obtaining
marketing approvals in the U.S and Europe".

^[1] Based on sales market data integrated from a 2012 report by Scrip
Intelligence, the 2011 annual report of GlaxoSmithKline and European 2011
sales data for carvedilol from IMS Health.

About RedHill Biopharma Ltd.:

RedHill Biopharma is 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. The Company's
current product pipeline includes a once-daily formulation of a leading
congestive heart failure and high blood pressure drug, a once-daily
formulation of a leading chemotherapy and radiotherapy-induced nausea and
vomiting prevention drug, an oral thin film formulation drug for the treatment
of acute migraines, a combination therapy for the treatment of Crohn's disease
as well as Multiple Sclerosis (MS), a combination therapy for the treatment of
Helicobacter pylori bacteria causing ulcers, and an encapsulated formulation
for bowel preparation ahead of certain gastro procedures. For more information
please visit: www.redhillbio.com.

Statements in this Press Release that are not historical facts, including the
regulatory status of the programs and the expected timing and description of
the clinical trials, are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements are based on the Company's current understanding of the regulatory
status and expectations of future events and are subject to significant
regulatory and development risks and uncertainties that could cause actual
results and development and regulatory progress to differ materially from
those expressed or implied by such statements, including (i) the initiation,
timing, progress and results of the Company's preclinical studies, clinical
trials, and other therapeutic candidate development efforts; (ii) the
Company's ability to advance its therapeutic candidates into clinical trials
or to successfully complete its preclinical studies or clinical trials; (iii)
the extent and number of additional studies that the Company may be required
to conduct and the Company's receipt of regulatory approvals for its
therapeutic candidates, and the timing of other regulatory filings and
approvals; (iv) the clinical development, commercialization, and market
acceptance of the Company's therapeutic candidates; (v) the Company's ability
to establish and maintain corporate collaborations; (vi) the interpretation of
the properties and characteristics of the Company's therapeutic candidates and
of the results obtained with its therapeutic candidates in preclinical studies
or clinical trials; (vii) the implementation of the Company's business model,
strategic plans for its business and therapeutic candidates; (viii) the scope
of protection the Company is able to establish and maintain for intellectual
property rights covering its therapeutic candidates and its ability to operate
its business without infringing the intellectual property rights of others;
(ix) estimates of the Company's expenses, future revenues capital requirements
and the Company's needs for additional financing; (x) competitive companies,
technologies and the Company's industry; and (xi) statements as to the impact
of the political and security situation in Israel on the Company's business.
More detailed information about the Company and the risk factors that may
affect the realization of forward-looking statements is set forth in the
Company's filings with the Securities and Exchange Commission (SEC), including
the Company's Registration Statement on From 20-F filed with the SEC on
December 26, 2012, and its Reports on Form 6-K. Investors and security holders
are urged to read these documents free of charge on the SEC's web site at
http://www.sec.gov. All forward-looking statements included in this Press
Release are made only as of the date of this Press Release. We assume no
obligation to update any written or oral forward-looking statement made by us
or on our behalf as a result of new information, future events or other
factors.

CONTACT: IR contact (US):
         Lauren Glaser
         Vice President
         The Trout Group
         +1-646-378-2972
         lglaser@troutgroup.com
        
         Company contact:
         Adi Frish
         Senior VP Business Development & Licensing
         RedHill Biopharma
         +972-54-6543-112
         adi@redhillbio.com
 
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