RedHill Biopharma Announces Issuance of New U.S. Patent and Provides Update on RHB-104 for Treatment of Crohn's Disease

RedHill Biopharma Announces Issuance of New U.S. Patent and Provides Update on
RHB-104 for Treatment of Crohn's Disease

   Patient Recruitment in an Initial Phase III Study is Planned to Commence
   Q2/2013; Multi-Site Initiation Process is Underway; Newly Issued Patent
                         Expires no Earlier Than 2029

  Additional Planned and Required Studies, Which Include a Second Phase III
  Crohn's Disease Trial in Europe and Other Supplementary Studies, Are Under
     Preparation as Part of RHB-104's Development and Regulatory Strategy

TEL-AVIV, Israel, Jan. 7, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill Biopharma"), an emerging
Israeli biopharmaceutical company focusing primarily on the development and
acquisition of late clinical-stage, patent-protected, new formulations and
combinations of existing drugs, reported today the issuance of a new U.S.
patent and that a multi-site initiation process is underway in the U.S.,
Canada and Israel for a first multi-center, randomized, double-blind,
placebo-controlled, parallel group initial Phase III study (the "MAP US
Study") to assess the efficacy and safety of fixed-dose combination RHB-104 in
subjects with moderately to severely active Crohn's disease. The MAP US Study
will be conducted under an Investigational New Drug (IND) application amended
in August 2012 and recruitment is planned to commence in the second quarter of
2013.

240 subjects will be randomized into the MAP US Study across up to 50 sites in
the U.S., Canada and Israel. The primary endpoint for this study is the state
of remission at week 26 in subjects randomized to receive RHB-104, as compared
to subjects randomized to receive placebo. Secondary and exploratory endpoints
will include, among others, state of response at 26 weeks, maintenance of
remission through week 52 and efficacy outcome measures in relation to
presence of MAP (Mycobacterium avium paratuberculosis) bacterial infection.
The study is exploratory with respect to the clinical validation of the
Company's proprietary Polymerase Chain Reaction (PCR) assay used to detect
MAP, the initial development of which was recently completed by Quest
Diagnostics. An appropriate regulatory path for the validation and approval of
the assay is currently being explored by the Company.

The lead investigator for the MAP US study will be Professor David Y. Graham,
MD from Baylor College of Medicine, Houston, Texas. Professor Graham is a
prominent gastroenterologist and internationally recognized researcher.

In addition to the MAP US Study which is designed to provide insights into
safety and efficacy of RHB-104 and initial assessment of the role of MAP in
Crohn's disease, the Company is planning and preparing for a Phase III
clinical trial in Europe with RHB-104 for the treatment of Crohn's disease
(the "MAP Europe Study") as well as supplementary studies required as part of
RHB-104's global development program and regulatory strategy.

On January 1, 2013, the United States Patent and Trademark Office issued a new
patent covering RHB-104 (No.: 8,343,511) entitled "Methods and Compositions
for Treating Inflammatory Bowel Disease", which expires no earlier than 2029.

Patrick Mclean, RHB-104 Product Manager at RedHill Biopharma said: "We are
extremely pleased that the RHB-104 MAP US Study is about to commence and look
forward to further advancing the development plan for this important
therapeutic treatment for Crohn's disease. Based on the relevant results of a
Phase III study with an earlier formulation of the drug conducted in 2007 by
Pfizer/Pharmacia in Australia, and the strong interest we are receiving from
Crohn's disease patients and the medical community, we are eager to enroll the
first patients into our study."

About RHB-104 and Crohn's disease:

RHB-104 is designed for the treatment of Crohn's disease which is an
inflammatory disease of the gastrointestinal system. It is a patent protected
combination therapy of three antibiotics in a single capsule. Several clinical
trials were conducted with formulations of the combination therapy, including,
among others, two Phase II studies and a Phase III study conducted in
Australia. RHB-104 builds on the success of Professor Thomas Borody, a leading
innovator of therapeutic approaches to gastrointestinal tract diseases and
infections, who formulated the original triple therapy for peptic ulcer
disease associated with Helicobacter pylori. Current therapies target
symptomatic relief of Crohn's disease and are widely considered of limited
efficacy in the long term and associated with numerous adverse events. The
RHB-104 combination therapy is based on increasing evidence supporting the
hypothesis that Crohn's disease, rather than being an autoimmune disease, is
caused by the dysregulation of immune responses secondary to infection in
susceptible patients. According to EvaluatePharma, a source for commercial
analysis of the pharmaceutical and biotech sector, the estimated worldwide
market in 2011 for diagnosis and drug treatment of Crohn's disease is $3
billion. In addition to Crohn's disease, RHB-104 is currently being developed
for the treatment of Multiple Sclerosis (MS), and the Company is in advanced
preparations for a Phase IIa study in Israel.

About RedHill Biopharma Ltd.:

RedHill Biopharma is an emerging Israeli biopharmaceutical company focused
primarily on the development 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) disease, 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: PR 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
 
Press spacebar to pause and continue. Press esc to stop.