01.06.2019 13:29:55
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Press Release: Novartis Kisqali significantly -2-
at least 3 weeks after the last dose of KISQALI. Patients should tell
their health care provider about all of the medicines they take,
including prescription and over-the-counter medicines, vitamins, and
herbal supplements since they may interact with KISQALI. Patients should
avoid grapefruit or grapefruit juice while taking KISQALI. The most
common side effects (incidence >=20%) include infections, white blood
cell count decreases, headache, cough, nausea, tiredness, diarrhea,
vomiting, constipation, hair loss and rash. The most common Grade 3/4
side effects (incidence >5%) were infections, low neutrophils, low
leukocytes, low red blood cells, abnormal liver function tests, low
lymphocytes, low phosphate levels and vomiting. Abnormalities were
observed in hematology and clinical chemistry laboratory tests.
Please see full Prescribing Information for KISQALI, available at
www.kisqali.com.
Disclaimer
This press release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform Act of
1995. Forward-looking statements can generally be identified by words
such as "potential," "can," "will," "plan," "expect," "anticipate,"
"look forward," "believe," "committed," "investigational," "pipeline,"
"launch," or similar terms, or by express or implied discussions
regarding potential marketing approvals, new indications or labeling for
the investigational or approved products described in this press release,
or regarding potential future revenues from such products. 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 the investigational or
approved products described in this press release 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
such products will be commercially successful in the future. In
particular, our expectations regarding such products 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 105 000 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
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] Hurvitz S, Seock-Ah I, Yen-Shen L et al. Phase III MONALEESA-7
trial of premenopausal patients with HR+/HER2- advanced breast cancer
(ABC) treated with endocrine therapy +/- ribociclib: Overall survival
(OS) results. Presented at the 2019 ASCO Meeting, June 1, 2019,
Abstract# LBA 1008.
[2] Benz CC. Impact of aging on the biology of breast cancer. Crit
Rev Oncol Hematol. 2008;66:65-74.
[3] World Health Organization. Top cancer per country, estimated
age-standardized mortality rates (World) in 2018, females, all ages.
2018. Available at http://gco.iarc.fr/today/home. Accessed May 2019
[4] Tripathy D, Sohn J, Im S, et al. First-line ribociclib or placebo
combined with goserelin and tamoxifen or a non-steroidal aromatase
inhibitor in premenopausal women with hormone receptor-positive,
HER2-negative advanced breast cancer: results from the randomized Phase
III MONALEESA-7 trial. Presented at the San Antonio Breast Cancer
Symposium (SABCS), December 6, 2017, (Abstract #S2-05).
[5] Novartis Data on File.
# # #
Novartis Media Relations
E-mail: media.relations@novartis.com
Julie Masow
Novartis Oncology Media Relations
+1 862 778 7220 (direct)
+1 862 579 8456 (mobile)
julie.masow@novartis.com
Eric Althoff
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 Richard Pulik +1 862 778 3275
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
Media release (PDF): http://hugin.info/134323/R/2245456/886958.pdf
This announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Novartis International AG via Globenewswire
--- End of Message ---
Novartis International AG
P.O. Box Basel Switzerland
WKN: 904278;ISIN: CH0012005267;
http://www.novartis.com
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