13.11.2020 16:00:16

Press Release: New Novartis analyses for -2-

use the small interfering RNA (siRNA mechanism) of action to lower

low-density lipoprotein cholesterol (LDL-C), which could help improve

outcomes for patients with atherosclerotic cardiovascular disease

(ASCVD), a deadly form of cardiovascular disease(5,6,) (14). With two

doses a year and effective and sustained LDL-C reduction, inclisiran

works as a complement to statins. Inclisiran works differently from

other therapies by preventing the production of the target protein in

the liver, increasing hepatic uptake of LDL-C and clearing it from the

bloodstream(14). Inclisiran is dosed initially, again at 3 months, and

then once every 6 months. In three clinical trials, patients taking

inclisiran maintained LDL-C reduction throughout each 6-month dosing

interval(5,6). Administered in-office as a subcutaneous injection,

inclisiran integrates seamlessly into a patient's healthcare

routine(5,6).

No significant safety or tolerability concerns have been identified with

the long-term administration of inclisiran. In the Phase III trials,

inclisiran was well-tolerated with a safety profile shown to be

comparable to placebo(5,6). The most common adverse reactions reported

(>=3% of patients treated with inclisiran and occurring more frequently

than placebo) were injection site reaction, arthralgia, urinary tract

infection, diarrhea, bronchitis, pain in extremity and dyspnea. Adverse

events at the injection site were generally mild and none were severe or

persistent(5,6).

Novartis has obtained global rights to develop, manufacture and

commercialize inclisiran under a license and collaboration agreement

with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.

About Novartis in Cardiovascular-Renal-Metabolism

Bending the curve of life requires addressing some of society's biggest

public health concerns. Novartis has an established and expanding

presence in diseases covering the heart, kidney and metabolic system. In

addition to essential treatment Entresto(R) (sacubitril/valsartan),

Novartis has a growing pipeline of potentially first-in-class molecules

addressing cardiovascular, metabolic and renal diseases.

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," "may," "could," "would,"

"expect," "anticipate," "seek," "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, economic and

business conditions, including the effects of and efforts to mitigate

pandemic diseases such as COVID-19; safety, quality, data integrity 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 nearly 800 million people globally

and we are finding innovative ways to expand access to our latest

treatments. About 110,000 people of more than 140 nationalities work at

Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at

https://twitter.com/novartisnews

For Novartis multimedia content, please visit

https://www.novartis.com/news/media-library

For questions about the site or required registration, please contact

media.relations@novartis.com

References

1. Wright RS, Ray KK, Raal FJ, et al. Efficacy and safety of

inclisiran according to sex: a pooled analysis of phase III studies

(ORION 9, 10 And 11). ePoster presentation (P2253) at: AHA Scientific

Sessions; November 2020.

2. Wright RS, Ray KK, Raal FJ, et al. Efficacy and safety of

inclisiran according to age: a pooled analysis of Phase III studies

(ORION 9, 10 And 11). ePoster presentation (P2250) at: AHA Scientific

Sessions; November 2020.

3. Ference B, Graham I, Tokgozoglu L, Catapano AL. Impact of lipids

on cardiovascular health: JACC health promotion series. J Am Coll

Cardiol. 2018;72:1141-1156.

4. Wong ND, Young D, Zhao Y, et al. Prevalence of the American

College of Cardiology/American Heart Association statin eligibility

groups, statin use, and low-density lipoprotein cholesterol control in

US adults using the National Health and Nutrition Examination Survey

2011-2012. J Clin Lipidol. 2016;10(5):1109-1118.

5. Raal FJ, Kallend D, Ray KK, et al. Inclisiran for the treatment

of heterozygous familial hypercholesterolemia. N Engl J Med.

2020;382(16):1520-1530. doi:10.1056/NEJMoa1913805.

6. Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of

inclisiran in patients with elevated LDL cholesterol. N Engl J Med.

2020;382:1507-1519. doi:10.1056/NEJMoa1912387.

7. Clinicaltrials.gov. ORION -9, -10, -11. Accessed October 21st,

2020. https://www.clinicaltrials.gov/ct2/show/NCT03397121;

https://clinicaltrials.gov/ct2/show/NCT03399370;

https://www.clinicaltrials.gov/ct2/show/NCT03400800.

8. Mayo Clinic. Arteriosclerosis / atherosclerosis. Available from:

https://www.mayoclinic.org/diseases-conditions/arteriosclerosis-atherosclerosis/symptoms-causes/

[Last accessed: October 2020].

9. Goldstein J, Brown M. A century of cholesterol and coronaries:

from plaques to genes to statins. Cell. 2015;161(1):161--172.

10. World Health Organization. Cardiovascular diseases (CVDs).

Available from:

https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

[Last accessed: October 2020].

11. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke

Statistics--2012 update. Circulation. 2012;125(1):e2--e220.

12. Kim H, Kim S, Han S, et al. Prevalence and incidence of

atherosclerotic cardiovascular disease and its risk factors in Korea: a

nationwide population-based study. BMC Public Health. 2019;19(1):1112.

13. National Cholesterol Education Program (NCEP) Expert Panel on

Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults

(Adult Treatment Panel III). Third Report of the National Cholesterol

Education Program (NCEP) Expert Panel on Detection, Evaluation, and

Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel

III) final report. Circulation. 2002;106(25):3143--3421.

14. Stoekenbroek RM, Kallend D, Wijngaard PL, et al. Inclisiran for

the treatment of cardiovascular disease: the ORION clinical development

program. Future Cardiol. 2018;14(6):433--442.

# # #

Novartis Media Relations

E-mail: media.relations@novartis.com

Anja von Treskow Phil McNamara

Novartis External Communications Global Head, Cardio-Renal-Metabolism

+41 61 324 2279 (direct) Communications

E-mail: anja.von_treskow@novartis.com +41 79 510 8756 (mobile)

E-mail: phil.mcnamara@novartis.com

Eric Althoff

Novartis US External Communications

+1 646 438 4335

E-mail: 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

Thomas Hungerbuehler +41 61 324 8425

Isabella Zinck +41 61 324 7188

(END) Dow Jones Newswires

November 13, 2020 10:00 ET (15:00 GMT)

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