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PRESS RELEASE: RedHill Biopharma Ltd.: RedHill -3-

| Quelle: Dow Jones Newswire Web
PRESS RELEASE: RedHill Biopharma Ltd.: RedHill Biopharma Initiates Promotion of Esomeprazole Strontium Delayed-Release Capsules 49.3 mg in the U.S

Dow Jones received a payment from EQS/DGAP to publish this press release.

===


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[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(R) (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate,
Scopolamine Hydrobromide)[2], EnteraGam(R) (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(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[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,
===
(MORE TO FOLLOW) Dow Jones Newswires

September 13, 2017 08:01 ET (12:01 GMT)

PRESS RELEASE: RedHill Biopharma Ltd.: RedHill -2-

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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 [1]

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch [2] or call 1-800-FDA-1088.

*About Donnatal(R):*
Donnatal(R) (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(R) slows the natural movements of the gut by
relaxing the muscles in the stomach and intestines. Donnatal(R) comes in two
formulations: immediate release Donnatal(R) Tablets and immediate release
Donnatal(R) Elixir, a fast-acting liquid.

*Important Safety Information about Donnatal(R):*
Donnatal(R) 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(R). 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 [3].

Please see the following website for complete important safety information
about Donnatal(R):
http://www.donnatal.com/professionals/important-safety-information/ [4]

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(R):*
EnteraGam(R) (serum-derived bovine immunoglobulin/protein isolate, SBI) is a
medical food product intended for the dietary management of chronic diarrhea
and loose stools. EnteraGam(R) must be administered under medical
supervision. EnteraGam(R) 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(R):*
EnteraGam(R) contains beef protein; therefore, patients who have an allergy
to beef or any other component of EnteraGam(R) should not take this product.
EnteraGam(R) has not been studied in pregnant women, in women during labor
and delivery, or in nursing mothers. The choice to administer EnteraGam(R)
during pregnancy, labor and delivery, or to nursing mothers is at the
clinical discretion of the prescribing physician.

EnteraGam(R) does not contain any milk-derived ingredients such as lactose,
casein or whey. EnteraGam(R) is gluten-free, dye-free and soy-free.

Please see full Product Information [5].

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(R)*, a prescription
oral adjunctive drug used in the treatment of IBS and acute enterocolitis,
and *EnteraGam(R)*, 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(R) (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(R) (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(R) (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 [6].

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(R) and
EnteraGam(R), (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
===
(MORE TO FOLLOW) Dow Jones Newswires

September 13, 2017 08:01 ET (12:01 GMT)

===
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.

*Company contact:* *IR & PR contact (Europe): *
Adi Frish Anne Hennecke
Senior VP Business Development & Managing Partner
Licensing MC Services AG
RedHill Biopharma +49-211-529252-22
+972-54-6543-112 anne.hennecke@mc-services.eu
adi@redhillbio.com

[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(R) (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-i
nformation-DTC-REV.-SE.pdf.
[3] EnteraGam(R) (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.

2017-09-13 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
609105 2017-09-13


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(END) Dow Jones Newswires

September 13, 2017 08:01 ET (12:01 GMT)

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