01.09.2019 14:29:53
|
Press Release: Novartis PARAGON-HF trial suggests -2-
1995. Forward-looking statements can generally be identified by words
such as "potential," "can," "will," "plan," "expect," "anticipate,"
"look forward," "believe," "committed," "investigational," "next steps,"
"to date," "could," "investigating," "ongoing," "emerging," "suggests,"
"may," or similar terms, or by express or implied discussions regarding
potential marketing approvals, new indications or labeling for Entresto,
or regarding potential future revenues from Entresto. You should not
place undue reliance on these statements. Such forward-looking
statements are based on our current beliefs and expectations regarding
future events, and are subject to significant known and unknown risks
and uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those set forth in the forward-looking
statements. There can be no guarantee that Entresto will be submitted or
approved for sale or for any additional indications or labeling in any
market, or at any particular time. Nor can there be any guarantee that
Entresto will be commercially successful in the future. In particular,
our expectations regarding Entresto could be affected by, among other
things, the uncertainties inherent in research and development,
including clinical trial results and additional analysis of existing
clinical data; regulatory actions or delays or government regulation
generally; global trends toward health care cost containment, including
government, payor and general public pricing and reimbursement pressures
and requirements for increased pricing transparency; our ability to
obtain or maintain proprietary intellectual property protection; the
particular prescribing preferences of physicians and patients; general
political and economic conditions; safety, quality or manufacturing
issues; potential or actual data security and data privacy breaches, or
disruptions of our information technology systems, and other risks and
factors referred to in Novartis AG's current Form 20-F on file with the
US Securities and Exchange Commission. Novartis is providing the
information in this press release as of this date and does not undertake
any obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or
otherwise.
About Novartis
Novartis is reimagining medicine to improve and extend people's lives.
As a leading global medicines company, we use innovative science and
digital technologies to create transformative treatments in areas of
great medical need. In our quest to find new medicines, we consistently
rank among the world's top companies investing in research and
development. Novartis products reach more than 750 million people
globally and we are finding innovative ways to expand access to our
latest treatments. About 108,000 people of more than 140 nationalities
work at Novartis around the world. Find out more at www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis or follow @NovartisNews for the latest News
& Media Updates at https://twitter.com/novartisnews
For Novartis multimedia content, please visit
www.novartis.com/news/media-library
For questions about the site or required registration, please contact
media.relations@novartis.com
References
[1] Solomon S, McMurray J, et al. Angiotensin-Neprilysin in Heart
Failure with Preserved Ejection Fraction. N Engl J Med. 2019; doi:
10.1056/NEJMoa1908655
[2] Ponikowski P, Voors A, et al. 2016 ESC Guidelines for the diagnosis
and treatment of acute and chronic heart failure. Eur Heart J.
2016;37:2129--2200. doi:10.1093/eurheartj/ehw128.
[3] Treatment for Heart Failure: Endpoints for Drug Development
Guidance for Industry. U.S. Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research
(CDER) and Center for Biologics Evaluation and Research (CBER). June
2019. Available at: https://www.fda.gov/media/128372/download. Accessed
July 17, 2019.
[4] McMurray J, Packer M, Desai A, et al. Angiotensin-neprilysin
inhibition versus enalapril in heart failure. N Engl J Med.
2014;371:993-1004. doi: 10.1056/NEJMoa1409077.
[5] Seferovic P, Ponikowski P, Anker S, et al. Clinical practice update
on heart failure 2019: pharmacotherapy, procedures, devices and patient
management. An expert consensus meeting report of The Heart Failure
Association of the European Society of Cardiology. Eur J Heart Fail.
2019. doi: 10.1002/ejhf.1531.
[6] Velazquez E, Morrow D, DeVore, A, et al., Angiotensin-Neprilysin
Inhibition in Acute Decompensated Heart Failure. N Engl J Med. 2018.
doi: 10.1056/NEJMoa1812851.
[7] Chandra A, Lewis E, Claggertt B, et al. The Effects of
Sacubitril/Valsartan on Physical and Social Activity Limitations in
Heart Failure Patients: The PARADIGM-HF Trial. JAMA Cardiol.
2018;3(6):498-505. doi: 10.1001/jamacardio.2018.0398.
[8] EMA. Entresto (sacubitril/valsartan). Summary of product
characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004062/WC500197536.pdf.
Accessed July 2019.
[9] Yancy C, Jessup M, et al. 2017 ACC/AHA/HFSA Focused Update of the
2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of
the American College of Cardiology/American Heart Association Task Force
on Clinical Practice Guidelines and the Heart Failure Society of
America. Circulation. 2017;136:e137-161. doi:
10.1161/CIR.0000000000000509.
[10] Solomon S, Rizkala A, et al. Angiotensin Receptor Neprilysin
Inhibition in Heart Failure with Preserved Ejection Fraction: Rationale
and Design of the PARAGON-HF Trial. JACC Heart Fail. 2017;5(7):471-482.
doi: 10.1016/j.jchf.2017.04.013.
[11] Solomon S, Zile M, et al. The angiotensin receptor neprilysin
inhibitor LCZ696 in heart failure with preserved ejection fraction: a
phase 2 double-blind randomised controlled trial. Lancet.
2012;380(9851):1387-1395. doi: 10.1016/S0140-6736(12)61227-6.
[12] Ndumele C, Matsushita K, et al. NT-proBNP and Heart Failure Risk
Among Individuals With and Without Obesity: The ARIC Study. Circulation.
2016;133:631-638. doi: 10.1161/CIRCULATIONAHA.115.017298.
[13] What is Heart Failure? American Heart Association. Website.
http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/What-is-Heart-Failure_UCM_002044_Article.jsp#.WvB9T6iPKyJ.
Updated March 7, 2018. Accessed July 20, 2019.
[14] Savarese G, Lund L. Global Public Health Burden of Heart Failure.
Card Fail Rev. 2017;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
[15] Borlaug B, Redfield M. Distolic and systolic heart failure are
distinct phenotypes within the heart failure spectrum. Circulation.
2011;123(18):2006-214. doi: 10.1161/CIRCULATIONAHA.110.954388.
[16] Ejection Fraction Heart Failure Measurement. American Heart
Association. Website.
https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement.
Published March 24, 2015. Accessed July 17, 2019.
[17] Dunlay S, Roger V, et al. Epidemiology of heart failure with
preserved ejection fraction. Nature Reviews Cardiology.
2017;14:591--602. doi: 10.1038/nrcardio.2017.65.
[18] Oktay A, Rich J, et al. The Emerging Epidemic of Heart Failure
with Preserved Ejection Fraction. Curr Heart Fail Rep.
2013;10(4):401-410. doi:10.1007/s11897-013-0155-7.
[19] Yancy C, Jessup M, et al. 2013 ACCF/AHA Guideline for the
Management of Heart Failure. J Am Coll Cardiol. 2013;62(16):e147-e239.
doi: 10.1016/j.jacc.2013.05.019.
[20] Owan T, Hodge D, et al. Trends in prevalence and outcome of heart
failure with preserved ejection fraction. N Engl J Med.
2006;355:251-259. doi: 10.1056/NEJMoa052256.
[21] Yancy C, Jessup M, et al. 2017 ACC/AHA/HFSA Focused Update of the
2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of
the American College of Cardiology/American Heart Association Task Force
on Clinical Practice Guidelines and the Heart Failure Society of
America. Circulation. 2017;136:e137-161. doi:
10.1161/CIR.0000000000000509.
[22] Langenickel T, Dole W. Angiotensin receptor-neprilysin inhibition
with LCZ696: a novel approach for the treatment of heart failure. Drug
Discov Today. 2012;9(4):e131-139. doi: 10.1016/j.ddstr.2013.11.002.
[23] ENTRESTO [prescribing information]. East Hanover, NJ: Novartis
Pharmaceuticals Corp; November 2018.
[24] Desai A, Claggett B, et al. Influence of Sacubitril/Valsartan
(LCZ696) on 30-Day Readmission After Heart Failure Hospitalization.
JACC. 2016;68(3):241-248. doi: 10.1016/j.jacc.2016.04.047.
# # #
Novartis Global External Communications
E-mail: media.relations@novartis.com
Peter Züst Eva Mispelbaum
Novartis Global External Communications Novartis Global Pharma Communications
+41 61 324 6383 (direct) +49 911 273 13 051 (direct)
peter.zuest@novartis.com +49 172 686 62 30 (mobile)
Eric Althoff eva.mispelbaum@novartis.com
Novartis US External Communications
+1 646 438 4335
eric.althoff@novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central North America
Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052
Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 862 778 3258
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
(END) Dow Jones Newswires
September 01, 2019 08:30 ET (12:30 GMT)
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu Novartis AGmehr Nachrichten
10:49 |
Novartis-Aktie dennoch mit Verlusten: US-Berufungsgericht stellt sich hinter Novartis-Patent für Entresto (dpa-AFX) | |
10:04 |
SMI-Papier Novartis-Aktie: So viel Gewinn hätte eine Novartis-Investition von vor 10 Jahren eingebracht (finanzen.at) | |
07:14 |
Press Release: Novartis Entresto(R) US patent upheld by US Court of Appeals (Dow Jones) | |
09.01.25 |
Optimismus in Zürich: SMI steigt zum Handelsende (finanzen.at) | |
09.01.25 |
SIX-Handel: SMI legt zu (finanzen.at) | |
08.01.25 |
Freundlicher Handel in Zürich: SMI zum Handelsende freundlich (finanzen.at) | |
07.01.25 |
Freundlicher Handel: SMI steigt zum Handelsende (finanzen.at) | |
07.01.25 |
Freundlicher Handel: STOXX 50 zeigt sich letztendlich fester (finanzen.at) |
Analysen zu Novartis AGmehr Analysen
09.01.25 | Novartis Neutral | Goldman Sachs Group Inc. | |
07.01.25 | Novartis Hold | Joh. Berenberg, Gossler & Co. KG (Berenberg Bank) | |
07.01.25 | Novartis Outperform | Bernstein Research | |
17.12.24 | Novartis Hold | Deutsche Bank AG | |
10.12.24 | Novartis Hold | Deutsche Bank AG |
Aktien in diesem Artikel
Novartis AG | 80,10 | -0,27% | |
Novartis AG (Spons. ADRS) | 96,40 | -0,41% |