DGAP-News: 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 +49-211-529252-22

+972-54-6543-112 [1]anne.hennecke@mc-services.eu

[1]adi@redhillbio.com 1. 1.

mailto:adi@redhillbio.com mailto:anne.hennecke@mc-ser

vices.eu

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18.09.2017 Veröffentlichung einer Corporate News/Finanznachricht,

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