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DGAP-News: RedHill Biopharma Ltd. / Key word(s): Miscellaneous
RedHill Biopharma Ltd.: RedHill Biopharma Initiates Promotion of
Esomeprazole Strontium Delayed-Release Capsules 49.3 mg in the U.S
2017-09-13 / 14:01
The issuer is solely responsible for the content of this announcement.
*RedHill Biopharma Initiates Promotion of Esomeprazole Strontium
Delayed-Release Capsules 49.3 mg in the U.S.*
? *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(R),
EnteraGam(R) and Esomeprazole Strontium DR Capsules 49.3 mg*
*TEL-AVIV, Israel / RALEIGH, NC, September 13, 2017* 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
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(R) (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate,
Scopolamine Hydrobromide), EnteraGam(R) (serum-derived bovine
immunoglobulin/protein isolate, SBI) 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. Esomeprazole Strontium DR Capsules 49.3 mg is
a proprietary prescription drug approved by the FDA under a New Drug
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.
*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
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(R) 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(R). Under the terms of the agreement, RedHill and
Concordia will share the revenues generated from the promotion of
Donnatal(R) by RedHill, based on an agreed upon split.
EnteraGam(R) 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(R) 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(R) by RedHill.
*About Esomeprazole Strontium Delayed-Release Capsules 49.3 mg:*
Esomeprazole Strontium Delayed-Release Capsules 49.3 mg is indicated for
? 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
? 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
? 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
? 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
? 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
? 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
? 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,
(MORE TO FOLLOW) Dow Jones Newswires
September 13, 2017 08:01 ET (12:01 GMT)
PRESS RELEASE: RedHill Biopharma Ltd.: RedHill Biopharma Initiates Promotion of Esomeprazole Strontium Delayed-Release Capsules 49.3 mg in the U.S| Quelle: Dow Jones Newswire Web
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