RedHill Biopharma Receives Notice of Allowance of Fifth U.S. Patent Covering RHB-104 Phase III Crohn’s Disease Program
February 10 2016 - 8:00AM
RedHill Biopharma Ltd. (NASDAQ:RDHL) (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:RDHL) (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™
(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™ (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® - 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™
(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.
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com
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