RedHill Biopharma Receives Positive Feedback From a Scientific Advice Meeting in Europe Regarding RHB-101 (Hypertension)

RedHill Biopharma Receives Positive Feedback From a Scientific Advice Meeting
in Europe Regarding RHB-101 (Hypertension) Marketing Application Plan

  *The Company held a Scientific Advice meeting regarding RHB-101 with the
    Danish Health and Medicines Authority (DKMA)
  *Following the positive results of the meeting, the Company intends to
    submit 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)
  *The Company is also continuing to explore the parallel regulatory path for
    marketing approval of RHB-101 in the U.S.
  *RHB-101 is a proprietary, controlled release, once-daily formulation of
    carvedilol, for the treatment of hypertension

TEL-AVIV, Israel, March 19, 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 European
Scientific Advice meeting with the Danish Health and Medicines Authority
(DKMA) regarding its cardio drug RHB-101, a controlled release, proprietary,
once-daily formulation of carvedilol, for the treatment of hypertension.

RedHill intends to submit a Marketing Authorization Application (MAA) in
Europe with Denmark as the reference member state for the European Mutual
Recognition Procedure (MRP). Based on the positive response in the official
minutes of the meeting with the DKMA, RedHill believes that no further
clinical studies will be required prior to submission of the MAA. The Company
plans to focus on certain chemistry, manufacturing and control modules, the
completion of which is expected to allow the submission of an MAA.

The Scientific Advice Meeting and the intended MAA submission follow 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 (the equivalent U.S. market brand name is Coreg^®, marketed by
GSK).

In parallel, RedHill is continuing to explore the regulatory path for
marketing approval of RHB-101 in the U.S.

"We are very encouraged by the positive feedback received from the Danish
Health and Medicines Authority (DKMA), and appreciate the informative
interactions and clarity provided by the DKMA," said Dr. Reza Fathi, RedHill's
Senior VP R&D. "We intend to advance the preparations for a planned MAA
submission with RHB-101, which, if approved, may be the first once-daily
controlled release formulation of carvedilol in the European market."

RHB-101 is a once-daily controlled release formulation of carvedilol, a
non-selective β-adrenergic blocking agent with α1-blocking activity. RHB-101
is based on a patented technology for the controlled release of drugs
administered orally.

With clear potential advantages over the generic immediate release carvedilol
available in the European market today, RHB-101 is targeting the European
carvedilol market of approximately $220 million (2011)^1, as well as the $240
million U.S. Coreg CR^® market (2011) and the $273 million U.S. generic
immediate release carvedilol market (2010)^2.

About RedHill Biopharma Ltd.:

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) 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 migraine, 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 (laxative) ahead
of colonoscopy. For more information, please visit: www.redhillbio.com.

This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Such statements may be
preceded by the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims," "believes,"
"hopes," "potential" or similar words. Forward-looking statements are not
guarantees of future performance, are based on certain assumptions and the
Company's current and best understanding of the regulatory status and are
subject to various known and unknown risks and uncertainties, many of which
are beyond the Company's control, and cannot be predicted or quantified and
consequently, actual results may differ materially from those expressed or
implied by such forward-looking statements. Such risks and uncertainties
include, without limitation, risks and uncertainties associated with (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 Annual Report on From 20-F filed with the SEC on February 19,
2013, 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.

^1 IMS Health

^2 IMS Health

CONTACT: PR contact (U.S.):
         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