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2016-11-10

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

RedHill Biopharma Ltd.
Press release

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 of H.
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™(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...

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