16.04.2019 22:44:54

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

(END) Dow Jones Newswires

April 16, 2019 16:45 ET (20:45 GMT)

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