TEL-AVIV, Israel, Jan. 12, 2017
(GLOBE NEWSWIRE) -- 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
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: RedHill Biopharma Ltd. via Globenewswire
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