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2016-11-10

RedHill Biopharma Ltd. : RedHill Biopharma Reports Positive FDA Type B Meeting on RHB-105 for H. pylori Infection Ahead of Confirmatory Phase III Study

* The confirmatory Phase III study with RHB-105 for H. pylori infection is
planned to be initiated in H1/2017, after completion of the ongoing
supportive PK program; Subject to a successful outcome, the confirmatory
Phase III study and the supportive PK program are expected to complete the
package required for a U.S. NDA for RHB-105, including clinical data and
chemistry, manufacturing and controls (CMC)
* Following the recent Type B CMC meeting, and subject to final minutes of
the meeting, the FDA has accepted RedHill's manufacturing plan towards
filing the CMC package as part of a potential future U.S. New Drug
Application (NDA) for RHB-105
* The first Phase III study with RHB-105 successfully demonstrated 89.4%
efficacy in eradicating H. pylori infection (p<0.001), supporting the
potential superior efficacy of RHB-105 over current standard-of-care (SoC)
therapies
* RHB-105 was granted QIDP designation by the FDA under the GAIN Act,
including Fast-Track development, NDA Priority Review and extended U.S.
market exclusivity, for a total of eight years
* With the rise in antibiotic resistance and consequent failure rates of SoC
therapies, H. pylori is an increasingly important human pathogen; It is a
major cause of chronic gastritis, peptic ulcer disease, gastric cancer and
mucosa-associated lymphoid tissue (MALT) lymphoma
* H. pylori infection is estimated to affect over half of the adult
population worldwide; The 2015 global and U.S. market potential for H.
pylori eradication therapies are estimated at approximately $4.83 billion
and $1.45 billion, respectively

TEL-AVIV, Israel, Nov. 10, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical
company primarily focused on the development and commercialization of late
clinical-stage, proprietary, orally-administered, small molecule drugs for
gastrointestinal and inflammatory diseases and cancer, today announced that
it has concluded a positive Type B Meeting with the U.S. Food and Drug
Administration (FDA) discussing the chemistry, manufacturing and controls
(CMC) aspects of the RHB-105 Phase III development program. RHB-105 is a
proprietary, fixed-dose, oral combination therapy for the eradication of H.
pylori
infection.

Subject to final minutes of the meeting, the FDA has accepted RedHill's
manufacturing plan towards filing the CMC package as part of a potential U.S.
New Drug Application (NDA) to be submitted for RHB-105, subject to successful
completion of the planned confirmatory Phase III study.

Following a previous positive FDA meeting announced in April 2016, and in
light of guidance received on the potential path for marketing approval of
RHB-105, advanced preparations continue for the confirmatory Phase III study
with RHB-105 for the treatment of H. pylori
infection. The two-arm, randomized, double-blind, active comparator
confirmatory Phase III study, comparing RHB-105 against a high-dose
amoxicillin and omeprazole regimen, is planned to be initiated in the first
half of 2017, after completion of the ongoing supportive pharmacokinetic (PK)
program. The confirmatory Phase III study is planned to enroll approximately
440 patients in up to 55 clinical sites in the U.S.

The planned confirmatory Phase III study, along with the results from the
successfully completed first Phase III study with RHB-105 (the ERADICATE Hp
study) and data to be obtained from the ongoing supportive PK program, are
expected to support an NDA for RHB-105.

The ERADICATE Hp Phase III study with RHB-105 successfully met its primary
endpoint of superiority over historical standard-of-care (SoC) eradication
rate of 70%, with high statistical significance (p<0.001). The ERADICATE Hp
study results demonstrated 89.4% efficacy in eradicating H. pylori
infection with RHB-105. Notably, subsequent open-label treatment with SoC
therapies of patients in the placebo arm of the ERADICATE Hp study
demonstrated only 63% eradication rate, further supporting the potential
superior efficacy of RHB-105 over SoC.

RHB-105 was granted Qualifying Infectious Disease Product (QIDP) designation
by the FDA, providing a Fast-Track development pathway, as well as NDA
Priority Review status, potentially leading to a shorter NDA review time by
the FDA, if filed. If approved, RHB-105 will also receive an additional five
years of U.S. market exclusivity, in addition to the standard exclusivity
period, for a total of 8 years of U.S. market exclusivity.

RedHill is pursuing with RHB-105 an indication of first-line treatment ofH.
pylori
infection, regardless of ulcer status, a significantly broader indication
than current standard treatments for H. pylori
, which are typically indicated only for patients with active or recent
history of duodenal ulcer disease. If approved, RHB-105 may be the first H.
pylori
eradication therapy to target this broader indication, which would
significantly expand the potential patient population for this drug
candidate.

H. pylori
bacterial infection is a major cause of chronic gastritis, peptic ulcer
disease, gastric cancer and mucosa-associated lymphoid tissue (MALT)
lymphoma. H. pylori
infection is estimated to affect over half of the adult population worldwide.
The growing resistance of the H. pylori
bacteria to metronidazole and clarithromycin has resulted in increasing
failure rates of current SoC for H. pylori
eradication, reaching an estimated 30%1. Despite the strong unmet medical
need, no new drug has been approved by the FDA for this indication in over a
decade.

The 2015 global and U.S. market potential for H. pylori
eradication therapies at current branded prices, were estimated at
approximately $4.83 billion and $1.45 billion, respectively, and could
potentially grow with increasing awareness of the health risks associated
with H. pylori
infection and the benefits of its eradication2.

About RHB-105:
RHB-105 is a new and proprietary fixed-dose oral combination therapy of two
antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule
with a planned indication for the treatment of H. pylori
infection. H. pylori
bacterial infection is a major cause of chronic gastritis, peptic ulcer
disease, gastric cancer and mucosa-associated lymphoid tissue (MALT)
lymphoma. A first Phase III study with RHB-105 was completed in the U.S. with
positive results (the ERADICATE Hp study). The study demonstrated an overall
success rate of 89.4% in eradicating H. pylori
, and met its protocol-defined primary endpoint of superiority in eradication
of H. pylori
infection over historical standard-of-care efficacy levels of 70%, with high
statistical significance (p<0.001).
A confirmatory Phase III study is planned to be initiated in the U.S.
Additional studies may be required, subject to FDA feedback. RHB-105 has been
granted Qualifying Infectious Disease Product (QIDP) designation by the FDA,
providing a Fast-Track development pathway, as well as NDA Priority Review
status, potentially leading to a shorter NDA review time by the FDA, if
filed. If approved, RHB-105 will also receive an additional five years of
exclusivity, in addition to the standard exclusivity period, for a total of 8
years of U.S. market exclusivity.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a biopharmaceutical
company headquartered in Israel, primarily focused on the development and
commercialization of late clinical-stage, proprietary, orally-administered,
small molecule drugs for the treatment of gastrointestinal and inflammatory
diseases and cancer. RedHill's pipeline of proprietary products includes: (i)
RHB-105
-
an oral combination therapy for the treatment of Helicobacter pylori
infection with successful results from a first Phase III study; (ii) RHB-104
-
an oral combination therapy for the treatment of Crohn's disease with an
ongoing first Phase III study and an ongoing proof-of-concept Phase IIa study
for multiple sclerosis; (iii) BEKINDA®
(RHB-102)
-
a once-daily oral pill formulation of ondansetron with an ongoing Phase III
study for acute gastroenteritis and gastritis and an ongoing Phase II study
for IBS-D; (iv) RHB-106
-
an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.;
(v) YELIVA(TM)(ABC294640)
-
a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor
targeting multiple oncology, inflammatory and gastrointestinal indications;
(vi) MESUPRON -
a Phase II-stage first-in-class, orally-administered uPA inhibitor, targeting
gastrointestinal and other solid tumors and (vii)RIZAPORT® (RHB-103) -
an oral thin film formulation of rizatriptan for acute migraines, with a U.S.
NDA currently under discussion with the FDA and marketing authorization
received in Germany in October 2015.

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 based
on certain assumptions 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 research, manufacturing, 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,
approvals and feedback; (iv) the manufacturing, 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 Company's ability to acquire products approved for
marketing in the U.S. that achieve commercial success and build its own
marketing and commercialization capabilities; (vii) the interpretation of the
properties and characteristics of the Company's therapeutic candidates and of
the results obtained with its therapeutic candidates in research, preclinical
studies or clinical trials; (viii) the implementat...

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