- RedHill's U.S.
gastrointestinal (GI)-focused sales force is promoting two
specialty products, setting the stage for the potential launch of
RedHill's late clinical-stage GI products, if approved, and for the
acquisition of additional commercial GI products
- The ERADICATE
Hp2 confirmatory Phase III study with TALICIA(TM) (RHB-105)
for H. pylori bacterial infection
is ongoing; TALICIA(TM) was granted QIDP designation by the
FDA
- Following a
unanimous positive DSMB recommendation, the Phase III MAP US study
with RHB-104 for Crohn's disease is continuing as planned; An
open-label extension Phase III study (the MAP US2 study) is ongoing
in parallel
- Following
positive top-line results from the Phase III study with
BEKINDA® 24 mg for acute gastroenteritis, the outcome of the
planned FDA Type B meeting to discuss the potential path to
marketing approval is expected to be announced in October
2017
- Top-line
results from the Phase II study with BEKINDA® 12 mg for
diarrhea-predominant irritable bowel syndrome (IBS-D) are expected
in September 2017
- In light of
recent FDA guidance on the potential path to marketing approval of
RHB-104 as first-line therapy for nontuberculous mycobacteria (NTM)
infections, RedHill plans, subject to regulatory approvals, to
initiate a pivotal Phase III study in the U.S. with RHB-104 for NTM
infections in the first quarter of 2018; RHB-104 was granted QIDP
designation by the FDA for the treatment of NTM
infections
- In light of
encouraging results from prior non-clinical studies, an NIAID
Safety Committee recently approved a planned proof-of-concept study
to evaluate RedHill's proprietary experimental therapy for the
treatment of Ebola virus disease; The study is expected to be
initiated in the fourth quarter of 2017
- Re-submission
of the NDA for RIZAPORT® for acute migraines is expected in
October 2017
TEL-AVIV, Israel and RALEIGH,
N.C., Aug. 10, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the
"Company"), a specialty biopharmaceutical company primarily focused
on late clinical-stage development and commercialization of
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.
Dror
Ben-Asher, Chief Executive Officer of RedHill,
said: "RedHill has transitioned into a
revenue-generating, gastrointestinal-focused, specialty
pharmaceutical company, as we continue to pursue important clinical
development milestones in the near future. I would like to thank
the RedHill team for their meaningful achievements on the R&D
and commercial fronts thus far in 2017."
TALICIA(TM) (RHB-105)1 - H.
pylori bacterial infection
(confirmatory Phase III) (QIDP status)
- A confirmatory Phase III study with
TALICIA(TM) (RHB-105) for the treatment of H. pylori infection (the ERADICATE Hp2 study) is
ongoing. The two-arm, randomized, double-blind, active comparator,
confirmatory Phase III study is planned to enroll 444
non-investigated dyspepsia patients with confirmed H. pylori infection in up to 65 clinical sites in
the U.S., with a primary endpoint of eradication of H. pylori infection at 42 through 70 days after
initiation of treatment. Subject to a successful outcome and any
additional regulatory feedback, the confirmatory Phase III study is
expected to complete the package required for a potential U.S. NDA
for TALICIA(TM). RHB-105 was granted QIDP (Qualified Infectious
Disease Product) designation by the FDA, allowing for Fast-Track
status and Priority Review, potentially leading to a shorter NDA
review time by the FDA, and, if approved, an additional five years
of U.S. market exclusivity on top of the standard exclusivity
period.
RHB-104 -
Crohn's disease (Phase III)
- To date, over 300 of the planned 410
subjects have been enrolled in the ongoing 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 pre-planned independent
data and safety monitoring board (DSMB) meeting reviewed safety and
efficacy data of the Phase III MAP US study from the first 222
subjects who have completed week 26 assessments in the MAP US
study, to which RedHill remains blinded. The independent DSMB
provided RedHill with a unanimous positive recommendation to
continue the study as planned.
- An open-label extension Phase III
study (the MAP US2 study) is ongoing to further assess the safety
and efficacy of RHB-104 in patients who remain out of remission
(CDAI greater than or equal to 150) after 26 weeks of blinded study
therapy in the ongoing Phase III MAP US study; these patients have
the opportunity to receive treatment with RHB-104 for a 52-week
period in the open-label extension study. To date, 12 patients have
been enrolled in the MAP US2 study.
RHB-104 -
nontuberculous mycobacteria (NTM) infections (Phase III) (QIDP
status)
- Following a positive meeting with
the FDA, and in light of their recent guidance on the potential
path toward marketing approval of RHB-104 as first-line therapy for
nontuberculous mycobacteria (NTM) infections, RedHill plans,
subject to approval of the study protocol by the FDA, to initiate a
pivotal Phase III study with RHB-104 for the treatment of NTM
infections in the first quarter of 2018.
- RHB-104 was granted QIDP designation
by the FDA for the treatment of NTM infections. The QIDP
designation was granted under the FDA's Generating Antibiotic
Incentives Now (GAIN) Act, which is intended to encourage
development of new antibiotic drugs for the treatment of serious or
life-threatening infections. Under the FDA's GAIN Act, QIDP
designation allows for Fast-Track status and Priority Review,
potentially leading to a shorter NDA review time by the FDA, and,
if approved, an additional five years of U.S. market exclusivity on
top of the standard exclusivity period.
BEKINDA® (RHB-102) 2 - acute
gastroenteritis (Phase III) and IBS-D (Phase II)
- Positive top-line results from the
Phase III GUARD study with BEKINDA® (RHB-102) 24 mg for acute
gastroenteritis and gastritis were announced in June 2017. The
study successfully met its primary endpoint of efficacy in acute
gastroenteritis and gastritis. BEKINDA® 24 mg was also found
to be safe and well tolerated in this indication. The randomized,
double-blind, placebo-controlled Phase III GUARD study evaluated
the efficacy and safety of BEKINDA® 24 mg in treating acute
gastroenteritis and gastritis in 321 adults and children over the
age of 12. The primary endpoint of the study was the proportion of
patients without further vomiting, without rescue medication, and
who were not given intravenous hydration from 30 minutes post first
dose of the study drug until 24 hours post dose, compared to
placebo. RedHill plans to meet with the FDA for a Type B meeting to
discuss the study results and the potential path to NDA filing. The
outcome of this meeting is expected to be announced in October
2017.
- The last patient has completed the
treatment course and the last follow-up visit in the Phase II study
with BEKINDA® 12 mg for the treatment of diarrhea-predominant
irritable bowel syndrome (IBS-D). The randomized, double-blind,
placebo-controlled Phase II study is evaluating the efficacy and
safety of BEKINDA® 12 mg in adults 18 years and older who
suffer from IBS-D. The study enrolled 127 subjects at 16 clinical
sites in the U.S. Top-line results are expected in September
2017.
YELIVA® (ABC294640) 3 - Phase I/II
studies for multiple oncology, inflammatory and GI
indications
- RedHill is currently pursuing
several Phase I/II clinical studies with YELIVA® (ABC294640)
in the U.S., with support from National Cancer Institute (NCI)
grants awarded to Apogee Biotechnology and U.S. universities,
including ongoing studies for advanced hepatocellular carcinoma
(Phase II, Medical University of South Carolina), refractory or
relapsed multiple myeloma (Phase Ib/II, Duke University Medical
Center) and refractory/relapsed diffuse large B-cell lymphoma and
Kaposi sarcoma (Phase I/IIa, Louisiana State University Health
Sciences Center).
- A Phase IIa clinical study with
YELIVA® in patients with advanced, unresectable, intrahepatic
and extrahepatic cholangiocarcinoma is planned to be initiated in
the fourth quarter of 2017. YELIVA® was granted Orphan Drug
designation by the FDA for the treatment of cholangiocarcinoma.
Orphan Drug designation would allow RedHill to benefit from a
seven-year marketing exclusivity period for the indication, if
approved, as well as other development incentives to develop
YELIVA®for cholangiocarcinoma.
- A Phase Ib study to evaluate
YELIVA® as a radioprotectant for prevention of mucositis in
head and neck cancer patients undergoing therapeutic radiotherapy
is planned to be initiated in the fourth quarter of 2017.
- A Phase II study for ulcerative
colitis is expected to be initiated in the fourth quarter of
2017.
RHB-106 - encapsulated
bowel preparation, exclusive worldwide rights licensed to Salix
Pharmaceuticals (now Valeant Pharmaceuticals
International)
- The exclusive worldwide rights to
RedHill's RHB-106 encapsulated bowel cleanser, as well as
additional related rights (RHB-106 Program), were licensed to Salix
Pharmaceuticals Ltd. in 2014, which was acquired by Valeant
Pharmaceuticals International Inc. (Valeant) in 2015. Valeant
remains fully responsible for the development of the RHB-106
Program and for future potential commercialization. RedHill
continues its discussion with Valeant regarding the RHB-106
Program.
RIZAPORT® (RHB-103) - acute migraines (approved for
marketing in Germany and Luxembourg)
- Re-submission of the
RIZAPORT® NDA to the FDA is expected in October
2017.
- The Ministry of Health of Luxembourg
granted national marketing authorization for RIZAPORT® (5 mg
and 10 mg) in April 2017. The national marketing authorization was
granted in Luxembourg on the basis of the European Decentralized
Procedure (DCP), in which Luxembourg served as the Concerned Member
State. The approval in Luxembourg marked the completion of the
current marketing approval process for RIZAPORT® under the
European DCP. RIZAPORT® is also approved for marketing in
Germany, which served as the Reference Member State, and a national
Marketing Authorization Application (MAA) has been submitted in
Spain.
- RedHill continues discussions with
additional potential commercialization partners for
RIZAPORT® in the U.S., Europe and other territories.
MESUPRON - pancreatic
cancer (Phase I/II)
- A Phase I/II study with MESUPRON in
unresectable pancreatic cancer is planned to be initiated in the
first half of 2018 in Germany.
Ebola virus disease therapy
(RedHill's proprietary experimental therapy) - NIH
collaboration
- Following approval by the U.S.
National Institute of Allergy and Infectious Diseases (NIAID)
Safety Committee, a non-clinical study to evaluate RedHill's
proprietary experimental therapy for the treatment of Ebola virus
disease is planned to be initiated in the fourth quarter of 2017.
RedHill's research collaboration with the NIAID, part of the
National Institutes of Health (NIH), is intended to evaluate
survival outcome and assess disease severity through comparison of
viral loads and cytokine levels in active treatment arms and
placebo. The study follows encouraging results from preliminary
non-clinical studies conducted in conjunction with NIAID using
RedHill's proprietary experimental therapy.
U.S.
Commercial Operations
- RedHill has established its U.S.
commercial operations in Raleigh, NC, and initiated the promotion
of two gastrointestinal products in June 2017. RedHill's U.S.
operations are intended to set the stage for the potential launch
of RedHill's proprietary, late-clinical stage GI products, if
approved by the FDA.
- RedHill's GI-focused sales force,
promotes two GI-specialty products, Donnatal® (Phenobarbital,
Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine
Hydrobromide)4 and EnteraGam® (serum-derived bovine
immunoglobulin/protein isolate, SBI)5 in select U.S.
territories. The sales force consists of approximately 40 sales
representatives. Initial net revenues for June 12-30, 2017 were
approximately $0.5 million. RedHill continues to pursue the
acquisition of additional commercial GI products in the U.S.
Expanded Access Program
(EAP)
- RedHill has adopted an Expanded
Access Program (EAP), allowing patients with life-threatening
diseases potential access to RedHill's investigational new drugs
that have not yet received regulatory marketing approval. Expanded
access (sometimes referred to as "compassionate use") is possible
outside RedHill's clinical trials, under certain eligibility
criteria, when a certain investigational new drug is needed to
treat life-threatening condition and there is some clinical
evidence suggesting that the drug might be effective in that
condition. Following the adoption of the program, RedHill continues
to receive patient requests to obtain access to investigational
drugs. Therefore, subject to evaluation of eligibility and all the
necessary regulatory and other approvals, RedHill is likely to
provide certain patients with an investigational new drug under the
EAP. Further information about RedHill's EAP can be found on the
Company's website
at: http://www.redhillbio.com/expandedaccess.
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. Donnatal® comes in
two formulations: immediate release Donnatal® Tablets and
immediate release Donnatal® Elixir, a fast-acting liquid.
Important
Safety Information about Donnatal®:
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 complete important safety information about
Donnatal®:
http://www.donnatal.com/professionals/important-safety-information/
To report suspected adverse
reactions, contact Concordia Pharmaceuticals Inc. at 1-877-370-1142
or email: medicalinformation@concordiarx.com, or the FDA at
1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
About
EnteraGam®:
EnteraGam® (serum-derived bovine immunoglobulin/protein
isolate, SBI) is a medical food product intended for the
dietary management of chronic diarrhea and loose
stools. EnteraGam® must be administered under medical
supervision. EnteraGam®binds microbial components6, such as toxic
substances released by bacteria, that upset the intestinal
environment. This helps prevent them from penetrating the lining of
the intestine, which may contribute to chronic diarrhea and loose
stools in people who have specific intestinal disorders7.
Safety
Information about EnteraGam®:
EnteraGam® contains beef protein; therefore, patients who have
an allergy to beef or any other component of EnteraGam® should
not take this product. EnteraGam® has not been studied
in pregnant women, in women during labor and delivery, or in
nursing mothers. The choice to administer
EnteraGam® during pregnancy, labor and delivery, or to nursing
mothers is at the clinical discretion of the prescribing
physician.
EnteraGam® does not contain
any milk-derived ingredients such as lactose, casein or whey.
EnteraGam® is gluten-free, dye-free and soy-free.
Please see full Product
Information.
To report suspected adverse
reactions, contact Entera Health, Inc. at 1-855-4ENTERA
(1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088)
or www.fda.gov/medwatch.
About
RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange: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 promotes two gastrointestinal products
in the U.S. - Donnatal®, a
prescription oral adjunctive drug used in the treatment of IBS and
acute enterocolitis, and EnteraGam®, a medical food intended for the
dietary management, under medical supervision, of chronic diarrhea
and loose stools. RedHill's clinical-stage pipeline includes:
(i) TALICIA(TM) (RHB-105) - an oral combination therapy for the
treatment of Helicobacter
pylori infection with successful results from a first
Phase III study and an ongoing confirmatory 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 planned Phase III
study for nontuberculous mycobacteria (NTM) infections;
(iii) BEKINDA® (RHB-102) - a once-daily oral pill formulation of
ondansetron with successful top-line results in a 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 protease inhibitor,
targeting pancreatic cancer 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 two EU member
states under the European Decentralized Procedure (DCP). More
information about the Company is available
at: www.redhillbio.com.
1 TALICIA® is an investigational new
drug, not available for commercial distribution.
2 BEKINDA® is an investigational new
drug, not available for commercial distribution.
3 YELIVA® is an investigational new
drug, not available for commercial distribution.
4 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. 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.
5 EnteraGam® (serum-derived bovine
immunoglobulin/protein isolate, SBI) is a commercially-available
medical food, intended for the dietary management of chronic
diarrhea and loose stools due to specific intestinal disorders,
which must be administered under medical supervision.
6 Horgan A, Maas K, Henderson
A, Detzel C, Weaver E. Serum-derived bovine immunoglobulin/protein
isolate binds to pathogen-associated molecular patterns. Poster
presented at: Federation of American Societies for Experimental
Biology; April 26-30, 2014; San Diego, CA.
7 Petschow BW, Burnett B,
Shaw AL, Weaver EM, Klein GL. Serum-derived bovine
immunoglobulin/protein isolate: postulated mechanism of action for
management of enteropathy. Clin Exp Gastroenterol.
2014;7:181-190.
Gasbarrini A, Lauritano EC, Garcovich M, Sparano L, Gasbarrini G.
New insights into the pathophysiology of IBS: intestinal
microflora, gas production and gut motility. Eur Rev Med Pharmacol
Sci. 2008;12 Suppl 1:111-117.
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 successfully market Donnatal® and
EnteraGam®, (vi) the Company's ability to establish and maintain
corporate collaborations; (vii) 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; (viii) 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; (ix) the implementation of
the Company's business model, strategic plans for its business and
therapeutic candidates; (x) 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; (xi) parties from whom the Company licenses its
intellectual property defaulting in their obligations to the
Company; and (xii) estimates of the Company's expenses, future
revenues capital requirements and the Company's needs for
additional financing; (xiii) the Company's Expanded Access Program,
which allows patients with life-threatening diseases potential
access, subject to regulatory and other approvals, to RedHill's
investigational new drugs that have not yet received regulatory
marketing approval, if a patient suffers an adverse experience
using such investigative drug, potentially adversely affecting the
clinical development program of that investigational product or the
Company generally; (xiv) competitive companies and technologies
within the Company's industry. 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 23, 2017. 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.