RedHill Biopharma Provides 2017 Semi-Annual Business Update
(Thomson Reuters ONE) -
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 subsidiary(2) 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(at)redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus(at)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
Datum: 12.01.2017 - 12:01 Uhr
Sprache: Deutsch
News-ID 517302
Anzahl Zeichen: 15111
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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