16.04.2019 22:44:54
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Press Release: Novartis: AveXis data reinforce -2-
granted Priority Review by the FDA, with regulatory action anticipated
in May 2019. In addition, the drug is anticipated to receive approval in
Japan and the European Union later this year.
About Spinal Muscular Atrophy (SMA)
SMA is a severe neuromuscular disease characterized by the loss of motor
neurons leading to progressive muscle weakness and paralysis. SMA is
caused by a genetic defect in the SMN1 gene that codes SMN, a protein
necessary for survival of motor neurons. The incidence of SMA is
approximately one in 10,000 live births and is the leading genetic cause
of infant mortality. The most severe form of SMA is Type 1, a lethal
genetic disorder characterized by rapid motor neuron loss and associated
muscle deterioration, which results in mortality or the need for
permanent ventilation support by 24 months of age for more than 90
percent of patients.
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
Zolgensma and the other investigational 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
Zolgensma or the other investigational 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 AveXis
AveXis, a Novartis company, is dedicated to developing and
commercializing novel treatments for patients suffering from rare and
life-threatening neurological genetic diseases. Our initial product
candidate, Zolgensma, is a proprietary gene therapy currently in
development for the treatment of spinal muscular atrophy, or SMA. In
addition to developing Zolgensma to treat SMA, AveXis also plans to
develop other novel treatments for rare neurological diseases, including
Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused
by mutations in the superoxide dismutase 1 (SOD1) gene. For additional
information, please visit www.avexis.com.
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] The brand name Zolgensma(R) (onasemnogene abeparvovec-xioi) has
been provisionally approved by the FDA for the investigational product
AVXS-101, but the product itself has not received marketing
authorization or BLA approval from any regulatory authorities.
[2] An event is defined as either death or at least 16 hours per day of
required ventilation support for breathing for 14 consecutive days in
the absence of acute reversible illness or perioperative change.
[3] Finkel RS, et al. Neurology. 2014;83:810-817.
[4] Colella P, et al. Mol Ther Methods Clin Dev. 2017;8:87-104.
[5] Calcedo R, et al. Clin Vaccine Immunol. 2011;18:1586-8.
[6] Mimuro J, et al. J Med Virol. 2014;86:1990-7.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com
Eric Althoff Farah Bulsara Speer
Novartis Global Media Relations VP, Corporate Communications, AveXis
+41 61 324 7999 (direct) +1 312 543 2881 (mobile)
+41 79 593 4202 (mobile) fSpeer259@avexis.com
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/2241833/884431.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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April 16, 2019 16:45 ET (20:45 GMT)
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Novartis AG | 80,10 | -0,27% | |
Novartis AG (Spons. ADRS) | 94,40 | -0,84% |