DGAP-News: RedHill Biopharma Ltd. / Key word(s): Miscellaneous
RedHill Biopharma Ltd.: RedHill Biopharma Provides 2016 R&D Update
04.03.2016 / 08:30
The issuer is solely responsible for the content of this announcement.
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Press Release
RedHill Biopharma Provides 2016 R&D Update
RedHill’s advanced pipeline includes three Phase III programs, several
Phase II programs and additional early-stage programs.
RedHill maintains a strong and debt-free balance sheet, allowing the
Company to continue to execute its development plans.
Key potential highlights for 2016 include:
– RedHill has completed enrollment of over half of the patients in the
RHB-104 Phase III study for Crohn’s disease and expects interim
analysis of the Phase III study in H2/2016
– Top-line results from the Phase III study with BEKINDA(TM) for
gastroenteritis are expected in H2/2016
– Initiation of a confirmatory Phase III study with RHB-105 for H. pylori
infection is expected in Q3/16
– Initiation of a Phase II study with BEKINDA(TM) for IBS-D and interim
top-line results from the Phase IIa proof-of-concept study with
RHB-104 for multiple sclerosis are expected in the coming weeks
– Following initial non-clinical studies, RedHill continues to advance
its collaboration with a U.S. government agency to test its proprietary
experimental combination therapy for treatment of Ebola virus disease
TEL-AVIV, Israel, March 4, 2016 RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL)
(“RedHill” or the “Company”), a 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 select key
research and development milestones and events anticipated in 2016.
RedHill’s pipeline includes several Phase III and Phase II-stage programs,
as well as earlier-stage development programs. Select potential highlights
for 2016 include:
RHB-104 – Crohn’s disease (Phase III) and multiple sclerosis (Phase IIa)
– RedHill has completed enrollment of over half of the planned 270
patients in the Phase III MAP US study for Crohn’s disease in the U.S.
and additional countries. Interim analysis of the MAP US study is
expected in the second half of 2016, after half of the patients
enrolled in the study complete 26 weeks of treatment. If approved for
marketing, RHB-104 is expected to become a potential paradigm changer
in the treatment of Crohn’s disease, targeting a worldwide market
estimated to exceed $6 billion in 2017 .
– Interim top-line results from the CEASE-MS study, an open label Phase
IIa, proof-of-concept clinical study exploring RHB-104 as an add-on
therapy to interferon beta-1a in patients treated for
relapsing-remitting multiple sclerosis (RRMS), are expected in the
coming weeks.
– RedHill and Quest Diagnostics (Q Squared Solutions LLC) continue to
make progress with the development of the Mycobacterium avium
subspecies paratuberculosis (MAP) companion diagnostic test following a
pre-submission meeting held with the U.S. Food and Drug Administration
(FDA) in 2015.
RHB-105 – H. pylori bacterial infection (Phase III)
– A meeting with the FDA is scheduled for April 2016 to discuss the
planned confirmatory Phase III study with RHB-105 in the U.S. for the
treatment of H. pylori infection.
– The FDA meeting follows positive top-line results from the ERADICATE Hp
first Phase III study with RHB-105, conducted in the U.S., which
successfully met its primary endpoint, demonstrating 89.4% efficacy in
eradicating H. pylori with high statistical significance (p< 0.001).
The
Complete Study Report (CSR) is expected in the coming weeks.
- The FDA has granted RHB-105 Qualified Infectious Disease Product (QIDP)
designation under the GAIN Act, allowing for a total of eight years of
market exclusivity, Fast-Track development and Priority Review status
which shortens review time for future marketing applications. RHB-105
is targeting a potential worldwide market estimated at approximately
$4.83 billion in 2015 .
BEKINDA(TM) (RHB-102) - acute gastroenteritis (Phase III) and IBS-D (Phase
II)
- Top-line results from the GUARD Phase III study with BEKINDA(TM) 24 mg
in the U.S. for acute gastroenteritis and gastritis are expected in the
second half of 2016. If approved for marketing by the FDA, BEKINDA(TM)
is expected to be the first-ever 5-HT3 antagonist drug indicated for
acute gastroenteritis, targeting a potential worldwide market estimated
to exceed $650 million annually .
- A Phase II study with BEKINDA(TM) 12 mg for diarrhea-predominant
irritable bowel syndrome (IBS-D) is planned to be initiated in the U.S.
in the coming weeks, subject to regulatory clearance. The U.S.
potential market for IBS-D treatments is estimated to exceed $1.3
billion by 2020 .
- RedHill is also pursuing potential marketing approval of BEKINDA(TM) in
Europe for the oncology support indications of chemotherapy and
radiotherapy-induced nausea and vomiting, pending additional
discussions and feedback from European Member States as to whether
additional clinical and CMC work is required.
YELIVA(TM) (ABC294640) - diffuse large B-cell lymphoma (Phase I/II),
refractory or relapsed multiple myeloma (Phase I/II) and radioprotection
(Phase II)
- A Phase I/II clinical study was initiated to evaluate YELIVA(TM) in
patients with refractory/relapsed diffuse large B-cell lymphoma
(DLBCL). The study is being conducted at the Louisiana State University
Health Sciences Center (LSUHSC) in New Orleans and is supported by a
grant awarded to Apogee Biotechnology Corp. ("Apogee"), from which
RedHill acquired the rights to YELIVA(TM), from the NCI Small Business
Technology Transfer (STTR) program, as well as additional support from
RedHill.
- A Phase I/II study with YELIVA(TM) for the treatment of refractory or
relapsed multiple myeloma is planned to be initiated during the second
quarter of 2016. The study will be conducted at Duke University Medical
Center and is supported by a $2 million grant from the NCI Small
Business Innovation Research Program (SBIR) awarded to Apogee in
conjunction with Duke University, with additional support from RedHill.
- A Phase II clinical study to evaluate YELIVA(TM) as a radioprotectant
to prevent mucositis in cancer patients undergoing therapeutic
radiotherapy is planned to be initiated in the U.S. during the second
half of 2016, subject to regulatory and other conditions.
- RedHill is pursuing additional oncology and gastrointestinal
indications with YELIVA(TM) and plans to initiate additional clinical
programs, subject to regulatory and other conditions.
MESUPRON(R) and RP101 - orally-administered oncology drug candidates (Phase
II-stage)
- RP101 - Results from the ongoing pre-clinical studies conducted in
collaboration with the Fraunhofer Institute for Cell Therapy and
Immunology (IZI), are expected during the first half of 2016. The
research collaboration tests RP101 in pre-clinical oncology models,
including pancreatic cancer, in combination with standard-of-care
chemotherapies, and is intended to support the existing Phase I and
Phase II clinical data with RP101 and to assess the drug's clinical
development path.
- MESUPRON(R) - Nonclinical studies are currently ongoing and are
intended to support the clinical data from previous Phase I and Phase
II studies with MESUPRON(R).
RIZAPORT(TM) (RHB-103) - acute migraines
- In 2015, the Federal Institute for Drugs and Medical Devices of Germany
(BfArM) granted marketing authorization of RIZAPORT(TM) 5 mg and 10 mg
under the European Decentralized Procedure (DCP), in which Germany
served as the Reference Member State. RedHill and IntelGenx Corp.
("IntelGenx") continue to work together to obtain national-phase
approvals of RIZAPORT(TM) in additional European DCP territories.
- RedHill and IntelGenx also continue to work together to bring
RIZAPORT(TM) to the U.S. market. The companies expect to re-submit the
RIZAPORT(TM) New Drug Application (NDA) to the FDA and receive a new
PDUFA (Prescription Drug User Fee) date in the fourth quarter of 2016.
Ebola virus disease - early stage, non-clinical development program
- Following positive initial non-clinical studies, RedHill continues to
advance its collaboration with a U.S. government agency to test the
antiviral activity of its proprietary experimental combination therapy
of orally-administered actives for the treatment of Ebola virus
disease.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is a 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 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
and an ongoing proof-of-concept Phase IIa study for multiple sclerosis;
(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 and a planned Phase II study for IBS-D; (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 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;
(vii) 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;
(viii) the implementation of the Company's business model, strategic plans
for its business and therapeutic candidates; (ix) 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; (x)
parties from whom the Company licenses its intellectual property defaulting
in their obligations to the Company; (xi) estimates of the Company's
expenses, future revenues capital requirements and the Company's needs for
additional financing; (xii) competitive companies and technologies within
the Company's industry; and (xiii) 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 25, 2016. 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: 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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