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 September 23, 2020
(Commission File No. 1-15024)
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Novartis AG
(Name of Registrant)
Lichtstrasse 35
4056 Basel
Switzerland
(Address of Principal Executive Offices)
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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
Novartis Provides Update on AVXS-101 Intrathecal Clinical Development
Program
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Novartis Gene Therapies to initiate new pivotal confirmatory study to evaluate use of AVXS-101
intrathecal (IT) formulation in older patients with SMA to further support registration
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Basel, September 23, 2020 – Novartis Gene Therapies recently
received feedback from the US Food and Drug Administration (FDA) following their review of data from the STRONG study of the intrathecal
(IT) formulation of AVXS-101 in older patients with spinal muscular atrophy (SMA). The FDA has acknowledged the potential of AVXS-101
IT in this patient population and recommends a pivotal confirmatory study to supplement the existing STRONG data and further support
the regulatory submission for AVXS-101 IT.
This guidance provides clarity on the path to registration for AVXS-101
IT. Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development
program will be provided at a future time following further discussions with health authorities. This request for a study is unrelated
to the partial clinical hold on AVXS-101 IT, and the new study will not be initiated in the US until the hold has been lifted by
the FDA. Novartis Gene Therapies remains confident in the overall benefit-risk profile for patients on treatment. This does not
impact marketed Zolgensma® (onasemnogene abeparvovec) and the company continues to advance its regulatory
filings and intravenous clinical studies.
Novartis Gene Therapies reaffirms its commitment to
the SMA community and to pursuing solutions for patients with all types of SMA, including older children and adults. All patients
deserve a gene therapy designed to address the genetic root cause of their disease with a single dose.
Zolgensma is approved in the US, Japan and, most recently, Brazil, for patients
with SMA under the age of two. Zolgensma also continues to have a strong launch in Europe where it is approved for babies and young
children with a clinical diagnosis of SMA Type 1 or SMA with up to three copies of the SMN2 gene, with dosing guidance provided
up to 21 kg. More than 600 patients have benefited from Zolgensma, including through clinical trials, commercially and through
the managed access program. This number is expected to continue to grow as this transformative gene therapy is approved in additional
markets and as the company pursues additional studies to fully explore the impact of Zolgensma across a broad population of patients
with SMA.
The company’s commitment to SMA extends beyond gene therapy to
branaplam (LMI070), an oral, once-weekly RNA splicing modulator also currently under development, to expand the treatment options
for SMA patients.
About Zolgensma® (onasemnogene abeparvovec)
Zolgensma® is designed to
address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through
sustained SMN protein expression with a single, one-time IV infusion. Zolgensma was approved by the US Food and Drug Administration
in May 2019 and represents the first approved therapeutic in the company’s proprietary platform to treat rare, monogenic
diseases using gene therapy. In addition to the US, Zolgensma is approved in Japan, Europe and Brazil. More than 600 patients have
been treated with Zolgensma, including clinical trials, commercially and through the managed access program. Novartis Gene Therapies
is pursuing registration in close to three dozen countries with regulatory decisions anticipated in Switzerland, Canada, Israel,
Australia, and South Korea in late-2020 or early 2021.
About Spinal Muscular Atrophy
SMA is the leading genetic cause of
infant death. If left untreated, SMA Type 1 leads to death or the need for permanent ventilation by the age of two in more
than 90% of cases. SMA is a rare, genetic neuromuscular disease caused by a lack of a functional SMN1 gene, resulting
in the rapid and irreversible loss of motor neurons, affecting muscle functions, including breathing, swallowing and basic
movement. It is imperative to diagnose SMA and begin treatment, including proactive supportive care, as early as possible to
halt irreversible motor neuron loss and disease progression. This is especially critical in SMA Type 1, where motor neuron
degeneration starts before birth and escalates quickly. Loss of motor neurons cannot be reversed, so SMA patients with
symptoms at the time of treatment will likely require some supportive respiratory, nutritional and/or musculoskeletal care to
maximize functional abilities. More than 30% of patients with SMA Type 2 will die by age 25.
About Novartis Gene Therapies
Novartis Gene Therapies (formerly AveXis) is reimagining medicine to
transform the lives of people living with rare genetic diseases. Utilizing cutting-edge technology, we are turning promising gene
therapies into proven treatments, beginning with our transformative gene therapy for spinal muscular atrophy (SMA). This therapy
is now approved in the US, Japan, Europe and Brazil, and additional registrations are being pursued in close to three dozen countries,
with regulatory decisions anticipated in Switzerland, Canada, Israel, Australia, Argentina and South Korea in late 2020 or early
2021. Our robust AAV-based pipeline is advancing treatments for Rett syndrome; a genetic form of amyotrophic lateral sclerosis
(ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene; and Friedreich’s ataxia. We are powered by the
world’s largest gene therapy manufacturing footprint of more than one million square feet, enabling us to bring these therapies
to patients around the world at quality and scale.
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 “to initiate,” “to evaluate,”
“to further support,” “potential,” “recommends,” “to supplement,” “being
evaluated,” “will,” “to advance,” “could,” “anticipated,” “remains,”
“continues,” “to advance,” “reaffirms,” “commitment,” “to pursuing,”
“to address,” “explore,” “investigational,” “launch,” “under development,”
or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for
AVXS-101 IT, Zolgensma and branaplam, or regarding potential future revenues from AVXS-101 IT, Zolgensma and branaplam. 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 AVXS-101 IT or branaplam will be submitted or
approved for sale in any market, or at any particular time. Neither can there be any guarantee that Zolgensma 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 AVXS-101 IT, Zolgensma or branaplam 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 109,000 people
of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
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Novartis
Media Relations
E-mail: media.relations@novartis.com
Anja von
Treskow
Novartis
External Communications
+41 79
392 8697 (mobile)
anja.von_treskow@novartis.com
Eric Althoff
Novartis
US External Communications
+1 646
438 4335
eric.althoff@novartis.com
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Farah
Bulsara Speer
SVP,
Corporate Communications, Novartis Gene Therapies
+1 312 543
2881 (mobile)
farah.speer@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
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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: September 23, 2020
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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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