DGAP-News: RedHill Biopharma Ltd.: RedHill Biopharma Receives Notice of Allowance of Fifth U.S. Patent Covering RHB-104 Phase III Crohn's Disease Program


DGAP-News: RedHill Biopharma Ltd. / Key word(s): Patent
RedHill Biopharma Ltd.: RedHill Biopharma Receives Notice of Allowance of
Fifth U.S. Patent Covering RHB-104 Phase III Crohn's Disease Program

10.02.2016 / 18:00
The issuer is solely responsible for the content of this announcement.

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Press Release

RedHill Biopharma Receives Notice of Allowance of Fifth U.S. Patent
Covering RHB-104 Phase III Crohn's Disease Program

  - Once granted, the new U.S. patent covering methods of use for RHB-104
    is expected to be valid through 2029

  - RHB-104 is undergoing a first Phase III study for the treatment of
    Crohn's disease in the U.S. and additional countries, with interim
    analysis expected during the second half of 2016

  - A Phase IIa proof-of-concept study evaluating RHB-104 in patients
    treated for relapsing-remitting multiple sclerosis is ongoing, with
    top-line interim results expected in the coming weeks

TEL-AVIV, Israel, February 10, 2016 RedHill Biopharma Ltd. (NASDAQ/TASE:
RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company
primarily focused on the development and commercialization of late
clinical-stage, proprietary, orally-administered, small molecule drugs for
inflammatory and gastrointestinal diseases, including cancer, today
announced that it has received a Notice of Allowance from the United States
Patent and Trademark Office (USPTO) for a new patent covering RHB-104.

RHB-104 is a proprietary and potentially groundbreaking antibiotic
combination therapy in oral capsule formulation, with potent intracellular,
anti-mycobacterial and anti-inflammatory properties, currently undergoing a
first Phase III study for Crohn's disease and a Phase IIa study for
multiple sclerosis.

The patent application, entitled "Compositions Comprising Rifabutin,
Clarithromycin, and Clofazamine and Uses Therof" significantly expands
RedHill's patent portfolio covering RHB-104 and is expected to be valid
until 2029 once granted. Upon issuance, RedHill will hold five U.S. patents
and multiple international patents for RHB-104.

Danielle Abramson, Ph.D., RedHill's Director of Intellectual Property &
Research said: "We are very pleased to announce this new addition to
RedHill's already robust patent portfolio covering RHB-104. The Phase III
study with RHB-104 for Crohn's disease, currently ongoing in the U.S. and
additional countries, is advancing well, with interim analysis expected in
the second half of 2016."

RHB-104 is currently undergoing a first Phase III study for Crohn's disease
in the U.S., Canada, Israel, Australia and additional countries (the MAP US
study). A second Phase III study (the MAP EU study) is planned to be
conducted in select European countries in parallel with the ongoing MAP US
study. Interim analysis of the ongoing randomized, double-blind,
placebo-controlled MAP US study is expected in the second half of 2016,
after half of the 270 patients planned to be enrolled in the study will
have completed 26 weeks of treatment.

RHB-104 is also being evaluated as a treatment for relapsing-remitting
multiple sclerosis (RRMS). The open label Phase IIa, proof-of-concept
clinical study is evaluating RHB-104 as an add-on therapy to interferon
beta-1a in patients treated for RRMS (the CEASE-MS study). Top-line interim
results are expected in the coming weeks.

The MAP US Phase III study and the CEASE-MS Phase IIa study are registered
on www.ClinicalTrials.gov, a web-based service of the U.S. National
Institutes of Health, which provides access to information on publicly and
privately supported clinical studies.

About RHB-104:
Currently in a first Phase III study for the treatment of Crohn's disease
(the MAP US study) and a second Phase III study which is being prepared
(the MAP EU study), RHB-104 is a proprietary and potentially groundbreaking
antibiotic combination therapy in oral capsule formulation, with potent
intracellular, anti-mycobacterial and anti-inflammatory properties. Interim
analysis of the MAP US Phase III study is expected in the second half of
2016.  RHB-104 is based on increasing evidence supporting the hypothesis
that Crohn's disease is caused by Mycobacterium avium subspecies
paratuberculosis (MAP) infection in susceptible patients. Clinical trials
conducted with earlier formulations of RHB-104 include an Australian Phase
III study conducted by Pfizer. RedHill has conducted several supportive
studies with the current formulation of RHB-104 and a long-term population
pharmacokinetic (pop-PK) study is ongoing as part of the Phase III MAP US
study. RHB-104 is covered by several issued and pending patents. RedHill is
also conducting a Phase IIa, proof-of-concept clinical study, evaluating
RHB-104 as an add-on therapy to interferon beta-1a in patients treated for
relapsing-remitting multiple sclerosis (RRMS), with top-line interim
results expected in the first quarter of 2016.
 
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is an emerging Israeli
biopharmaceutical company primarily focused on the development and
commercialization of late clinical-stage, proprietary, orally-administered,
small molecule drugs for the treatment of inflammatory and gastrointestinal
diseases, including cancer. RedHill's current pipeline of proprietary
products includes: (i) RHB-105 - an oral combination therapy for the
treatment of Helicobacter pylori infection with successful top-line 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;
(iii) BEKINDA(TM) (RHB-102) - a once-daily oral pill formulation of
ondansetron with an ongoing Phase III study in the U.S. for acute
gastroenteritis and gastritis; (iv) RHB-106 - an encapsulated bowel
preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA(TM)
(ABC294640) - an orally-administered first-in-class SK2 selective inhibitor
targeting multiple oncology, inflammatory and gastrointestinal indications
with a Phase I/II study initiated for refractory/relapsed diffuse large
B-cell lymphoma (DLBCL); (vi) MESUPRON(R) - a Phase II-stage first-in-class
uPA inhibitor, administered by oral capsule, targeting gastrointestinal and
other solid tumors; (vii) RP101 - currently subject to an option-to-acquire
by RedHill, RP101 is a Phase II-stage first-in-class Hsp27 inhibitor,
administered by oral tablet, targeting pancreatic and other
gastrointestinal cancers; (viii) RIZAPORT(TM) (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; and (ix) RHB-101 - a once-daily oral pill
formulation of the cardio drug carvedilol.

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 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; (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) parties from whom the Company
licenses its intellectual property defaulting in their obligations to the
Company; (x) estimates of the Company's expenses, future revenues capital
requirements and the Company's needs for additional financing; (xi)
competitive companies and technologies within the Company's industry; and
(xii) 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 Form 20-F filed
with the SEC on February 26, 2015. 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 unless required by law.
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Company contact:                                      IR contact (U.S.):
Adi Frish                                             Marcy Nanus
Senior VP Business Development &                      Senior Vice President
                                                      The Trout Group
Licensing                                             +1-646-378-2927
RedHill Biopharma                                     Mnanus@troutgroup.com
+972-54-6543-112
adi@redhillbio.com


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10.02.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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