RedHill Biopharma Receives Notice of Allowance for a New U.S. Patent Covering its Combination Therapy for Hard-to-Treat Cancers

    RedHill Biopharma Receives Notice of Allowance for a New U.S. Patent Covering its Combination
Therapy for Hard-to-Treat Cancers

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DGAP-News: RedHill Biopharma Ltd. / Schlagwort(e): Patent
RedHill Biopharma Receives Notice of Allowance for a New U.S. Patent
Covering its Combination Therapy for Hard-to-Treat Cancers

18.09.2017 / 14:46
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.

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RedHill Biopharma Receives Notice of Allowance for a New U.S. Patent
Covering its Combination Therapy for Hard-to-Treat Cancers

TEL-AVIV, Israel / RALEIGH, NC, September 18, 2017 RedHill Biopharma Ltd.
(NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"),
a specialty biopharmaceutical company primarily focused on late
clinical-stage development and commercialization of proprietary,
orally-administered, small molecule drugs for gastrointestinal and
inflammatory diseases and 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 the use of two of RedHill's Phase II-stage
proprietary investigational compounds, YELIVA(R) and MESUPRON in combination
with a known antibiotic.

Upon issuance, on top of existing intellectual property protection covering
the individual compounds, the new patent will provide RedHill with
intellectual property protection covering its combination for the potential
treatment of cancer, prevention of cancer recurrence or progression and
inhibition of growth and proliferation of cancer cells.

Danielle Abramson, Ph.D., RedHill's VP of Intellectual Property and Research,
stated: "We are very pleased with the allowance of this key patent, covering
the combination of our proprietary, first-in-class, orally-administered
Phase II-stage drug candidates, YELIVA(R) and MESUPRON, both of which are
new chemical entities, with a known antibiotic. As part of our oncology
program, RedHill is currently evaluating the new combination therapy across
several oncology indications with limited treatment options where strong
unmet medical need exists."

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a
specialty 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 promotes
three gastrointestinal products in the U.S. - Donnatal(R), a prescription
oral adjunctive drug used in the treatment of IBS and acute enterocolitis,
EnteraGam(R), a medical food intended for the dietary management, under
medical supervision, of chronic diarrhea and loose stools, and Esomeprazole
Strontium Delayed-Release Capsules 49.3 mg, a prescription proton pump
inhibitor indicated for adults for the treatment of gastroesophageal reflux
disease (GERD) and other gastrointestinal conditions. RedHill's
clinical-stage pipeline includes: (i) TALICIA(TM) (RHB-105) - an oral
combination therapy for the treatment of Helicobacter pylori infection with
successful results from a first Phase III study and an ongoing confirmatory
Phase III study; (ii) RHB-104 - an oral combination therapy for the
treatment of Crohn's disease with an ongoing first Phase III study, a
completed proof-of-concept Phase IIa study for multiple sclerosis, and a
planned pivotal Phase III study for nontuberculous mycobacteria (NTM)
infections; (iii) BEKINDA(R) (RHB-102) - a once-daily oral pill formulation
of ondansetron with successful top-line results from a 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(R) (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 protease
inhibitor, targeting pancreatic cancer and other solid tumors and (vii)
RIZAPORT(R) (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 two EU member states under the European
Decentralized Procedure (DCP). More information about the Company is
available at: 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 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 successfully market Donnatal(R) and
EnteraGam(R), (vi) the Company's ability to establish and maintain corporate
collaborations; (vii) 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; (viii) 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; (ix) the implementation of the
Company's business model, strategic plans for its business and therapeutic
candidates; (x) 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; (xi) parties from whom the Company
licenses its intellectual property defaulting in their obligations to the
Company; and (xii) estimates of the Company's expenses, future revenues
capital requirements and the Company's needs for additional financing;
(xiii) the Company's Expanded Access Program, which allows patients with
life-threatening diseases potential access, subject to regulatory and other
approvals, to RedHill's investigational new drugs that have not yet received
regulatory marketing approval, if a patient suffers an adverse experience
using such investigative drug, potentially adversely affecting the clinical
development program of that investigational product or the Company
generally; (xiv) competitive companies and technologies within the Company's
industry. 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 23, 2017. 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.

   Company contact: Adi Frish Senior    IR & PR contact (Europe): Anne
   VP Business Development &            Hennecke Managing Partner MC
   Licensing RedHill Biopharma          Services AG [phone]
   [phone]                     [1][e-mail]
   [1][e-mail]  1.            1.
   mailto:[e-mail]            mailto:anne.hennecke@mc-ser
                                        vices.eu


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