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 announced that it has initiated promotion of
Esomeprazole Strontium Delayed-Release (DR) Capsules 49.3 mg1 in
the U.S.
RedHill’s U.S. commercial operations,
headquartered in Raleigh, NC, includes a gastrointestinal-focused
sales force of approximately 40 sales representatives promoting
three gastrointestinal (GI)-specialty products, Donnatal®
(Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine
Hydrobromide)2, EnteraGam® (serum-derived bovine
immunoglobulin/protein isolate, SBI)3 and Esomeprazole Strontium DR
Capsules 49.3 mg in select U.S. territories. RedHill’s U.S.
commercial operations are expected to pave the way for the
potential future launch of RedHill’s late clinical-stage GI
products, if approved by the U.S. Food and Drug Administration
(FDA).
Esomeprazole Strontium DR Capsules 49.3 mg is a
prescription proton pump inhibitor (PPI) drug product indicated for
adults for the treatment of gastroesophageal reflux disease (GERD),
risk reduction of NSAID-associated gastric ulcer, H. pylori
eradication to reduce the risk of duodenal ulcer recurrence and for
pathological hypersecretory conditions, including Zollinger-Ellison
syndrome4. Esomeprazole Strontium DR Capsules 49.3 mg is a
proprietary prescription drug approved by the FDA under a New Drug
Application (NDA).
PPIs are one of the most commonly prescribed
classes of medications in the U.S., with an estimated market value
exceeding $20 billion in 20165.
Valerie Graceffa, RedHill’s VP, U.S.
Sales and Marketing, said: “We are excited to initiate the
promotion of a third GI-specialty product. Esomeprazole Strontium
DR Capsules 49.3 mg was selected as a strategic fit for RedHill’s
growing GI-focused product portfolio, which our sales force has
been actively promoting in select U.S. territories since June 2017.
Our sales team has been well trained and is eager to consult
gastroenterologists on the new product and provide patients with an
additional therapeutic option.”
RedHill has a commercialization agreement with
ParaPRO LLC (“ParaPRO”), an Indiana-based specialty pharmaceutical
company, granting RedHill the exclusive rights to promote
Esomeprazole Strontium DR Capsules to gastroenterologists in
certain U.S. territories. Under the terms of the agreement, RedHill
was not required to make any upfront, nor future milestone
payments, and the parties will share the revenues generated from
the promotion of Esomeprazole Strontium DR Capsules 49.3 mg by
RedHill based on an agreed upon split between them. The initial
term of the commercialization agreement is for four years. ParaPRO
has also initiated its promotion of Esomeprazole Strontium DR
Capsules 49.3 mg.
Donnatal® is a prescription oral drug used with
other drugs for the treatment of irritable bowel syndrome
(irritable colon, spastic colon, mucous colitis) and acute
enterocolitis (inflammation of the small bowel). RedHill has an
exclusive co-promotion agreement with Concordia Pharmaceuticals
Inc., a subsidiary of Concordia International Corp. (NASDAQ:CXRX)
(TSX:CXR) (“Concordia”), granting RedHill certain U.S. promotion
rights for Donnatal®. Under the terms of the agreement, RedHill and
Concordia will share the revenues generated from the promotion of
Donnatal® by RedHill, based on an agreed upon split.
EnteraGam® is a medical food intended for the
dietary management of chronic diarrhea and loose stools which must
be administered under medical supervision. RedHill has a license
agreement with Entera Health Inc. (“Entera Health”), granting
RedHill the exclusive U.S. rights to EnteraGam® for the term of the
agreement. Under the terms of the agreement, RedHill will pay
Entera Health royalties based on net sales generated from the sale
of EnteraGam® by RedHill.
About Esomeprazole Strontium
Delayed-Release Capsules 49.3 mg6:Esomeprazole Strontium
Delayed-Release Capsules 49.3 mg is indicated for adults:
- for the short-term treatment (4-8 weeks) of heartburn and other
symptoms associated with gastroesophageal reflux disease (GERD)
and/or in healing and symptomatic resolution of erosive esophagitis
(EE).
- to reduce the risk of stomach ulcers in some people taking
non-steroidal anti-inflammatory drugs (NSAIDs) (controlled studies
did not extend beyond 6 months).
- in combination with amoxicillin 1000 mg and clarithromycin 500
mg is indicated for the treatment of patients with a stomach
infection (Helicobacter pylori) and duodenal ulcer disease.
- is indicated for the long-term treatment of pathological
hypersecretory conditions, including Zollinger-Ellison
Syndrome.
Important Safety Information about
Esomeprazole Strontium Delayed-Release Capsules 49.3
mg:
- Esomeprazole strontium is contraindicated in patients with
known hypersensitivity to proton pump inhibitors. For
information about contraindications of antibacterial agents
(clarithromycin and amoxicillin) indicated in combination with
esomeprazole strontium, refer to the contraindications section of
their package inserts.
- Symptomatic response to therapy does not rule out the presence
of gastric malignancy. Consider additional follow-up and diagnostic
testing in adult patients who have a suboptimal response or an
early symptomatic relapse after completing treatment with a proton
pump inhibitor (PPI). In older patients, also consider an
endoscopy.
- Acute interstitial nephritis has been observed in patients
taking PPIs. Discontinue esomeprazole strontium if acute
interstitial nephritis develop.
- PPI therapy may be associated with increased risk of
Clostridium difficile-associated diarrhea. This diagnosis should be
considered for diarrhea that does not improve.
- PPI therapy may be associated with an increased risk of
osteoporosis-related fractures of the hip, wrist, or spine. The
risk of fracture was increased in patients who received high-dose
(multiple daily doses) and long-term (a year or longer)
therapy.
- Cutaneous lupus erythematosus (CLE) and systemic lupus
erythematosus (SLE) have been reported in patients taking PPIs,
including esomeprazole. These events included both new onset and
exacerbations. If signs or symptoms consistent with CLE or SLE are
noted with esomeprazole strontium, discontinue and refer the
patient to a specialist. Most patients improve with discontinuation
of the PPI alone in 4 to 12 weeks.
- Avoid concomitant use of esomeprazole strontium with
clopidogrel, due to a reduction in plasma concentrations of the
active metabolite of clopidogrel. When using esomeprazole strontium
consider alternative anti-platelet therapy.
- Daily treatment with any acid-suppressing medications over a
long period of time (e.g., longer than 3 years) may lead to
malabsorption of cyanocobalamin (vitamin B12). Rare reports of
cyanocobalamin deficiency occurring with acid-suppressing therapy
have been reported in the literature.
- Hypomagnesemia has been reported rarely with prolonged
treatment with PPI therapy and may require discontinuing PPI
therapy.
- Concomitant use of esomeprazole strontium and St. John’s wort
or rifampin can substantially decrease esomeprazole strontium
concentrations. Avoid concomitant use.
- Literature suggests that concomitant use of PPIs with
methotrexate (primarily at high dose; see methotrexate prescribing
information) may elevate and prolong serum levels of methotrexate
and/or its metabolite, possibly leading to methotrexate toxicities.
In high-dose methotrexate administration, a temporary withdrawal of
the PPI may be considered in some patients.
- Concomitant use of esomeprazole strontium and atazanavir or
nelfinavir is not recommended. esomeprazole strontium is expected
to increase the plasma levels of saquinavir. Consider dose
reduction of saquinavir.
- Patients treated with PPIs and warfarin concomitantly may need
to be monitored for increases in INR and prothrombin time.
Esomeprazole may interfere with the absorption of drugs for which
gastric pH affects bioavailability (e.g., ketoconazole, iron salts,
erlotinib, digoxin and mycophenolate mofetil).
- Esomeprazole strontium may increase systemic exposure of
cilostazol and one of its active metabolites. Consider dose
reduction of cilastozol.
- In adults, adverse reactions (ARs) reported at a frequency of
1% or greater with esomeprazole strontium include headache,
diarrhea, nausea, flatulence, abdominal pain, constipation, and dry
mouth.
- Safety and effectiveness of esomeprazole strontium have not
been established in pediatric patients. Not recommended for use in
pediatric patients.
- Safety of esomeprazole strontium have not been studied in
patients with severe renal impairment. Not recommended for use in
patients with severe renal impairment.
Talk to your doctor or healthcare professional.
Please see Prescribing information including Medication Guide for
Esomeprazole Strontium Delayed-Release Capsules at
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
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 breastfeeding 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 components7, 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 disorders8.
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 ParaPRO LLC:ParaPRO is a
Specialty Pharmaceutical Company created in 2002 to acquire,
develop, and commercialize proprietary products in focused high
potential markets. ParaPRO is a wholly owned subsidiary of SePRO
Corporation, a management owned life-sciences business. Started in
1994, SePRO Corporation is a research-based life
sciences company providing innovative products and services for
specialty environmental and human health markets worldwide. SePRO
is recognized as a preeminent leader in the aquatics industry and
as a vital player in professional turf, horticulture and landscape
markets.
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 three 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, and Esomeprazole Strontium
Delayed-Release Capsules 49.3 mg, a prescription
proton pump inhibitor indicated for adults for the treatment of
gastroesophageal reflux disease (GERD) and other gastrointestinal
conditions. RedHill’s clinical-stage pipeline includes: (i)
TALICIA™ (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 pivotal 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.
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.
_____________________________
1 Esomeprazole Strontium Delayed-Release (DR)
Capsules 49.3 mg is an FDA-approved, proprietary, prescription
proton pump inhibitor, indicated for adults for the treatment of
gastroesophageal reflux disease (GERD) and other gastrointestinal
(GI) conditions. For more information, please see the prescribing
information:
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display
2 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.
3 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.
4 For more information, please see the
prescribing
information: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display
5 Symphony Health (accessed August, 2017)
6 Esomeprazole Strontium Delayed-Release Capsules is also
available in a 24.65 mg dose. RedHill promotes the Esomeprazole
Strontium Delayed-Release Capsules 49.3 mg formulation only.
7 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.
8 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.
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