UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 or 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
Report on Form 6-K dated December 22, 2021
(Commission File No. 1-15024)
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Novartis AG
(Name of Registrant)
Lichtstrasse 35
4056 Basel
Switzerland
(Address of Principal Executive Offices)
____________________
Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F:
Form 20-F: ☒
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Form 40-F: ☐
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
Indicate by check mark whether the registrant by furnishing the information contained
in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
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Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com
https://twitter.com/novartisnews
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MEDIA & INVESTOR RELEASE
FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and
keep it low with two doses a year
Ad hoc announcement pursuant to Art. 53 LR
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With
two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol)
reduction1
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Leqvio
provides effective and sustained LDL-C reduction of up to 52% vs. placebo for certain people with atherosclerotic cardiovascular disease
(ASCVD) on maximally tolerated statin therapy2,3
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Approximately
16 million Americans with ASCVD taking statins to lower cholesterol—including those who have experienced a heart attack or stroke—are
not at recommended LDL-C target4,5
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Basel, December 22, 2021 — Novartis today announced the US Food and Drug
Administration (FDA) approval of Leqvio® (inclisiran), the first and only small interfering RNA (siRNA) therapy to
lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year, after an initial dose and one
at three months.
“Leqvio is a revolutionary approach to lower LDL-C, and creates new possibilities for
how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time,” said Vas Narasimhan,
Novartis CEO. “We now have the opportunity, working together with partners, to provide this first-ever approved LDL-C–lowering
siRNA-based therapy to tackle ASCVD at scale across the United States.”
Leqvio is indicated in the United States as an adjunct to diet and maximally tolerated statin
therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia
(HeFH) who require additional lowering of LDL-C. The effect of Leqvio on cardiovascular morbidity and mortality is being explored in clinical
trials currently underway.
“ASCVD is a substantial public health burden affecting 30 million Americans,” said Norman Lepor, MD, a Los Angeles based cardiologist
and a clinical investigator in the Phase III clinical program for Leqvio. “As a first-of-its-kind siRNA therapy, Leqvio works differently
than other cholesterol treatments, with twice-yearly dosing that makes it a compelling option for the millions of people with ASCVD already
on cholesterol-lowering medications struggling to reach their LDL-C target.”
Leqvio reduces the amount of LDL-C in the bloodstream by improving the liver’s natural
ability to prevent the production of a protein that plays a role in keeping circulating cholesterol levels high6,7. It is a
subcutaneous injection given by a healthcare provider with an initial dose, then again at three months, and then every six months1.
This approach may help those who have trouble sticking to medicines that are self-administered and have greater dosing frequency. Leqvio
will be available in early January 2022.
“People with ASCVD have most likely experienced a heart attack or stroke from high cholesterol,
causing a burden on the family and having a negative impact on lives,” said Andrea Baer, Executive Director of The Mended Hearts,
Inc. “One of the first steps to improving patients’ health is to manage high cholesterol and we’re encouraged that this
new twice-a-year treatment offers a new option.”
The FDA approval was based on results from the comprehensive Phase III ORION-9, -10 and -11
clinical trials, in which all 3,457 participants with ASCVD or HeFH had elevated LDL-C while receiving a maximally tolerated dose of statin
therapy2,3. In the Phase III trials at month 17, Leqvio delivered effective and sustained LDL-C reduction of up to 52% vs.
placebo and was reported to be well-tolerated with a safety profile shown to be comparable to placebo2,3. The most common side
effects were mild to moderate injection site reaction (including pain, redness and rash), joint pain, urinary tract infection, diarrhea,
chest cold, pain in legs or arms and shortness of breath2,3.
Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a
license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.
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 “will,” “may,” “believe,”
“keep,” “taking on,” next-generation,” “enables,” “to explore,” “innovative,”
“to help,” “improving,” “keeping,” “to develop,” “possible,” “goal,”
or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Leqvio,
or regarding potential future revenues from Leqvio. 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 Leqvio 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 Leqvio will be successfully launched in the markets where it is approved, or at any particular time. Neither can there be any guarantee
that Leqvio will be commercially successful in the future. In particular, our expectations regarding Leqvio 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 in cardiovascular renal metabolism
Cardiovascular (CV), renal and metabolic diseases are a global health crisis8-11.
These chronic, complex and often hereditary diseases are frequently inter-related, and come
with healthcare and treatment barriers and a lack of transformative medicines, and almost always lead to the same outcome: death due to
CV disease8-11.
CV disease is the number one killer in the world8. Taking more lives than all cancers
combined, it contributes to one in every three deaths globally8,12. Of all CV events, 80% can be prevented13. Patients
and their families deserve better, and our society deserves more.
Thanks to a combination of our legacy, global footprint and leading science, Novartis is uniquely
positioned to help change this landscape. We are transforming the way we think about the relationship between these diseases and how they
are managed throughout life. Our efforts include the use of early interventions and the development of pioneering treatments that address
the spectrum of CV, renal and metabolic diseases, from prevention to management, as well as the creation of innovative access models.
By re-writing the way we work with society, we will lead a worldwide effort to improve health outcomes and roll back the crisis of CV
death.
Our goal is to bend the curve of life by reducing and stopping premature death from CV disease.
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 108,000 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
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1.
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Leqvio
prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.
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2.
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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(16):1507-1519. doi:10.1056/NEJMoa1912387
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3.
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Raal
FJ, Kallend D, Ray KK, et al. Inclisiran for heterozygous familial hypercholesterolemia. N
Engl J Med. 2020;382(16):1520-1530. doi:10.1056/NEJMoa1913805
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4.
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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. doi: 10.1016/j.jacl.2016.06.011
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5.
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Grundy
MS, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/ AGS/APhA/ASPC/NLA/PCNA
Guideline on the Management of Blood Cholesterol: a report of the American College of Cardiology/American
Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139:e1082–e1143.
doi: 10.1161/CIR.0000000000000625
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6.
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Khvorova
A. Oligonucleotide therapeutics—a new class of cholesterol-lowering drugs. N
Engl J Med. 2017;376(1):4-7. doi: 10.1056/NEJMp1614154
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7.
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Kosmas
CE, Muñoz Estrella A, Sourlas A, et al. Inclisiran: a new promising agent in the management
of hypercholesterolemia. Diseases. 2018;6(3):63. doi: 10.3390/diseases6030063
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8.
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World
Health Organization. Cardiovascular diseases (CVDs). June 11, 2021. Accessed November 23,
2021. https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
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9.
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National
Kidney Foundation. Global Facts: About Kidney Disease. Accessed November 23, 2021. https://www.kidney.org/kidneydisease/global-facts-about-kidney-disease
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10.
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Levey
AS, Atkins R, Coresh J, et al. Chronic kidney disease as a global public health problem:
approaches and initiatives—a position statement from Kidney Disease Improving Global
Outcomes. Kidney Int. 2007;72(3):247-259. doi: 10.1038/sj.ki.5002343
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11.
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World
Health Organization. Diabetes. November 10, 2021. Accessed November 23, 2021. https://www.who.int/news-room/fact-sheets/detail/diabetes
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12.
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American Cancer Society. Global Cancer Facts & Figures 4th Edition. Atlanta, GA: American Cancer Society; 2018.
Accessed November 23, 2021.
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-4th-edition.pdf
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13.
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World Health Organization. Cardiovascular diseases: Data and statistics. Accessed November 23, 2021.
https://www.euro.who.int/en/health-topics/noncommunicable-diseases/cardiovascular-diseases/data-and-statistics
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# # #
Novartis Media Relations
E-mail: media.relations@novartis.com
Jamie Bennett
Director, US External Engagement
+1 862 217 3976
jamie.bennett@novartis.com
Julie Masow
Novartis US External Communications
+1 862 579 8456
julie.masow@novartis.com
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Phil McNamara
Global Head, Novartis Cardio-Renal-Metabolic Communications
+41 79 510 8756 (mobile)
philip.mcnamara@novartis.com
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Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central
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North America
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Samir Shah
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+41 61 324 7944
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Sloan Simpson
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+1 862 345 4440
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Thomas Hungerbuehler
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+41 61 324 8425
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Alina Levchuk
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+1 862 778 3372
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Isabella Zinck
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+41 61 324 7188
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Parag Mahanti
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+1 973-876-4912
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# # #
SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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Novartis AG
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Date: December 22, 2021
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By:
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/s/ PAUL
PENEPENT
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Name:
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Paul Penepent
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Title:
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Head Group Financial Reporting and
Accounting
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