RedHill Biopharma Initiates Promotion of Esomeprazole Strontium Delayed-Release Capsules 49.3 mg in the U.S.

ID: 1520657
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(Thomson Reuters ONE) -


* Esomeprazole Strontium Delayed-Release (DR) Capsules 49.3 mg is an FDA-
approved, proprietary, prescription proton pump inhibitor (PPI) indicated
for adults for the treatment of gastroesophageal reflux disease (GERD) and
other gastrointestinal (GI) conditions

* PPIs are one of the most commonly prescribed classes of medications in the
U.S., with an estimated market value exceeding $20 billion in 2016

* RedHill''s GI-focused sales force, headquartered in Raleigh, NC, promotes
three GI-specialty products in the U.S., Donnatal(®), EnteraGam(® )and
Esomeprazole Strontium DR Capsules 49.3 mg

TEL-AVIV, Israel and RALEIGH, N.C., Sept. 13, 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 announced that it has initiated promotion of
Esomeprazole Strontium Delayed-Release (DR) Capsules 49.3 mg(1) 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 syndrome(4). 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 2016(5).

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 mg(6):
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(at)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 components(7), 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 disorders(8).

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((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
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=532
40ab5-98e7-4050-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=5324
0ab5-98e7-4050-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(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






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Date: 09/13/2017 - 07:00
Language: English
News-ID 1520657
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