RedHill Biopharma Receives Notice of Allowance for a New U.S. Patent Covering its Combination Therapy for Hard-to-Treat Cance...
September 18 2017 - 8:00AM
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® 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® 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®, a prescription oral adjunctive drug
used in the treatment of IBS and acute enterocolitis,
EnteraGam®, 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™ (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® (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® (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® (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® and EnteraGam®, (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 FrishSenior VP Business Development &
Licensing RedHill Biopharma+972-54-6543-112adi@redhillbio.com |
IR contact
(U.S.): Marcy NanusSenior Vice President The Trout
Group+1-646-378-2927Mnanus@troutgroup.com |
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