RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the
“Company”), a specialty biopharmaceutical company primarily focused
on the development and commercialization of late clinical-stage,
proprietary, orally-administered, small molecule drugs for
gastrointestinal and inflammatory diseases and cancer, today
provided an update on key programs, potential milestones and
estimated timelines.
Micha Ben Chorin, RedHill’s CFO,
said: “We are heading into 2017 with important potential
catalysts in the coming months and with several ongoing Phase III
and Phase II programs for gastrointestinal indications. Following
the recently announced U.S. co-promotion agreement for Donnatal®1,
RedHill is advancing its strategic transition into a
revenue-generating, gastrointestinal-focused, specialty
pharmaceutical company with commercial presence in the U.S. This
transition is planned to support potential future commercialization
of RedHill’s Phase III-stage gastrointestinal drugs, if approved by
the FDA. We are backed by strong institutional investors and
maintain a debt-free balance sheet with approximately $70 million
in cash, allowing us to continue to diligently execute our
plans.”
RHB-105 - H.
pylori bacterial infection (confirmatory
Phase III)
- The confirmatory Phase III study with RHB-105 for the treatment
of H. pylori infection, expected to enroll 440 patients
in up to 55 U.S. sites, is planned to be initiated by April 2017
following completion of an ongoing supportive pharmacokinetic (PK)
program.
RHB-104 - Crohn’s disease (Phase III)
- 254 of the planned total of 410 subjects have been enrolled to
date in the randomized, double-blind, placebo-controlled first
Phase III study in the U.S. and additional countries with RHB-104
for Crohn’s disease (the MAP US study).
- A second independent data and safety monitoring board (DSMB)
meeting of the MAP US study is expected in the second quarter of
2017, with an interim efficacy analysis and an option for early
stop for success for overwhelming efficacy.
BEKINDA® (RHB-102) - acute gastroenteritis (Phase
III) and IBS-D (Phase II)
- 291 of the planned total of 320 subjects have been enrolled to
date in the randomized, double-blind, placebo-controlled Phase III
clinical study with BEKINDA® 24 mg in the U.S. for acute
gastroenteritis and gastritis (the GUARD study). Top-line results
are expected by mid-2017.
- 83 of the planned total of 120 subjects have been enrolled to
date in the randomized, double-blind, placebo-controlled Phase
II clinical study with BEKINDA® 12 mg for the treatment of
diarrhea-predominant irritable bowel syndrome (IBS-D). Top-line
results are expected in mid-2017.
YELIVA® - Phase
I/II studies for multiple oncology and inflammatory
indications
- RedHill is currently pursuing several Phase I/II clinical
studies with YELIVA® in the U.S., targeting oncology
indications, with support from National Cancer Institute (NCI)
grants awarded to Apogee Biotechnology and U.S. universities,
including ongoing studies for advanced hepatocellular carcinoma
(Medical University of South Carolina), refractory or relapsed
multiple myeloma (Duke University Medical Center) and
refractory/relapsed diffuse large B-cell lymphoma and Kaposi
sarcoma (Louisiana State University Health Sciences Center).
- Additional Phase I/II studies with YELIVA® are in various
stages of preparation, including a Phase Ib study to evaluate
YELIVA® as a radioprotectant for prevention of mucositis in head
and neck cancer patients undergoing therapeutic radiotherapy,
planned to be initiated in the first half of 2017.
Donnatal®
(Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate,
Scopolamine Hydrobromide)
- As part of RedHill’s strategic transition into a
revenue-generating, gastrointestinal-focused, specialty
pharmaceutical company with a commercial presence in the U.S., the
Company entered earlier this month into an exclusive co-promotion
agreement with a subsidiary2 of Concordia International Corp.
(NASDAQ:CXRX) (TSX:CXR), granting RedHill certain U.S. promotion
rights for Donnatal®, a prescription oral drug used with other
drugs in the treatment of irritable bowel syndrome (irritable
colon, spastic colon, mucous colitis) and acute enterocolitis
(inflammation of the small bowel)3. RedHill expects to initiate
promotion of Donnatal® in the coming months.
RIZAPORT® (RHB-103) - acute migraines (approved for
marketing in Germany)
- Re-submission of the RIZAPORT® NDA to the FDA is expected in
the first half of 2017. RIZAPORT® was approved for marketing
in Germany under the European Decentralized Procedure (DCP) in
October 2015 and a first commercialization agreement was signed
with Grupo JUSTE S.A.Q.F for Spain and a second commercialization
agreement was signed with Pharmatronic Co. for South Korea. RedHill
continues discussions with additional potential commercialization
partners for RIZAPORT® in the U.S., Europe and other
territories.
About Donnatal®:Donnatal®
(Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate,
Scopolamine Hydrobromide), a prescription drug, is classified
as possibly effective as an adjunctive therapy in the treatment of
irritable bowel syndrome (irritable colon, spastic colon, mucous
colitis) and acute enterocolitis. Donnatal® slows the natural
movements of the gut by relaxing the muscles in the stomach and
intestines and acts on the brain to produce a calming effect.
Donnatal® comes in two formulations: immediate release
Donnatal® Tablets and immediate release Donnatal® Elixir,
a fast acting liquid.
Donnatal® is contraindicated in patients who
have glaucoma, obstructive uropathy, obstructive disease of the
gastrointestinal tract, paralytic ileus, unstable cardiovascular
status, severe ulcerative colitis, myasthenia gravis, hiatal hernia
with reflux esophagitis, or known hypersensitivity to any of the
ingredients. Patients who are pregnant or breast-feeding or who
have autonomic neuropathy, hepatic or renal disease,
hyperthyroidism, coronary heart disease, congestive heart failure,
cardiac arrhythmias, tachycardia or hypertension should notify
their doctor before taking Donnatal®. Side effects may include:
dryness of the mouth, urinary retention, blurred vision, dilation
of pupils, rapid heartbeat, loss of sense of taste, headache,
nervousness, drowsiness, weakness, dizziness, insomnia, nausea,
vomiting and allergic reactions which may be severe.
Further information, including prescribing
information, can be found on www.donnatal.com.
Please see the following website for important
safety information about Donnatal®:
http://www.donnatal.com/professionals/important-safety-information/
About RedHill Biopharma
Ltd.: RedHill Biopharma Ltd.
(NASDAQ:RDHL) (TASE: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 has
a U.S. co-promotion agreement with Concordia for
Donnatal®, a prescription oral adjunctive drug
used in the treatment of IBS and acute enterocolitis. RedHill’s
clinical-stage pipeline includes: (i) RHB-105
- an oral combination therapy for the treatment of
Helicobacter pylori infection with successful 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, a completed proof-of-concept
Phase IIa study for multiple sclerosis and a QIDP status for NTM;
(iii) BEKINDA® (RHB-102)
- a once-daily oral pill formulation of
ondansetron with an ongoing 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 uPA inhibitor,
targeting gastrointestinal 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 Germany in October 2015. More information about the
Company is available at: www.redhillbio.com.
1 Donnatal® (Phenobarbital, Hyoscyamine Sulfate,
Atropine Sulfate, Scopolamine Hydrobromide) is a prescription
drug, classified as possibly effective as an adjunctive
therapy in the treatment of irritable bowel syndrome (irritable
colon, spastic colon, mucous colitis) and acute enterocolitis.
2 Concordia Pharmaceuticals Inc.
3 This drug has been evaluated as possibly effective for
these indications. For more information, please see the prescribing
information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.
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:
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