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 July 27, 2018
(Commission File No. 1-15024)
____________________
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: ☒
|
|
Form 40-F: ☐
|
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.
|
|
|
|
Media
Release
|
Medienmitteilung
|
Communiqué Aux Médias
|
|
|
|
|
|
|
|
|
Sandoz
International Industriestr.
|
|
|
83607
Holzkirchen,Germany
|
|
|
Tel: +49
8024 476 2596
|
|
|
Fax:
+49 8024 476 2599
|
|
|
www.sandoz.com
|
Sandoz receives European
Commission approval for biosimilar Hyrimoz® (adalimumab)
·
|
Biosimilar
Hyrimoz
®
(adalimumab) approved
for
use
in
all
same
indications as reference medicine
†
*
including rheumatology, gastroenterology
and
dermatology
|
·
|
Early therapeutic
intervention
is
essential
in rheumatoid arthritis, supporting
urgency of
treatments like Hyrimoz
|
·
|
Fourth
Sandoz biosimilar approved in Europe** in past
18
months,
and seventh
in
total, underscoring Sandoz commitment
to
making
access happen through
a
robust
portfolio
|
Holzkirchen, July
27,
2018
–
Sandoz,
a
Novartis
division
and the pioneer and global leader
in
biosimilars,
today
announced that the European Commission
(EC)
granted marketing authorization
to
biosimilar
Hyrimoz
®
(adalimumab) for
use
in
all indications of
the
reference
medicine
†
*, including rheumatoid arthritis, plaque psoriasis, Crohn's disease,
uveitis
and ulcerative colitis.
1
,
2
Rheumatoid
arthritis
alone affects up to 1% of people in
the
European Union. Patients
with
moderate
to
severe rheumatoid arthritis can have chronic inflammation
that
causes fatigue, pain and joint stiffness. Symptoms can be
reversible with
appropriate treatment, however the joint damage and the
resulting
disability are
permanent.
3
The
introduction
of
biosimilars has
been shown to improve access
to
advanced treatment options,
such
as
biologic medicines.
4
“We
believe in
making access
happen
for
patients
who are suffering
from chronic
inflammatory diseases.
Earlier
and
expanded access to important, disease-modifying, biologic medicines can fundamentally change how
patients
manage their health,”
said
Stefan Hendriks,
Global
Head of Biopharmaceuticals, Sandoz. “Biosimilars such
as
Hyrimoz can also play
a transformational role
in healthcare
system sustainability – so
we
look forward
to
making Hyrimoz,
and
other important
biosimilar
medicines, broadly available.”
The
approval
was
based on a comprehensive data package comprising analytical,
preclinical
and clinical research demonstrating that Hyrimoz matches the reference
biologic
in
terms of
safety,
efficacy and technical
quality.
A randomized, double-blind, three-arm,
parallel
study confirmed
the
pharmacokinetics, immunogenicity and safety of Hyrimoz. The study
met
the
primary
endpoint, demonstrating bioequivalence for
all
primary
pharmacokinetic parameters. A Phase
III
confirmatory safety and efficacy
study
(ADACCESS) demonstrated therapeutic
equivalence in
the sensitive indication
of
patients with
moderate
to severe
chronic plaque-type psoriasis,
with
a similar safety and immunogenicity profile to
the reference biologic. No meaningful clinical differences were observed.
5
-
7
Sandoz
is
well-positioned to
lead
the biosimilars industry based on
its
experience
and
capabilities in development, manufacturing and commercialization.
Hyrimoz
is
the
company’s
seventh
approved
biosimilar
medicine in Europe. Additional biosimilars
for
oncology and
immunology
indications
are expected to launch globally across major
regions
by
2020.
About
Hyrimoz
®
(adalimumab)
Hyrimoz
is
an inhibitor of
tumor
necrosis
factor (TNF), a protein
that is
overproduced in certain autoimmune conditions—including
rheumatoid arthritis, plaque psoriasis, Crohn's
disease and
ulcerative colitis—causing
inflammation
and
tissue destruction
in
joints, mucosa
or
skin. In
some
cases
of autoimmune disease, the immune
system
damages
the
body’s own
tissues. Hyrimoz can be a potentially appropriate treatment
option
for certain patients across a variety of indications. Hyrimoz works by targeting
and
blocking
the
protein that contributes to disease symptoms.
1
|
|
|
|
Media
Release
|
Medienmitteilung
|
Communiqué Aux Médias
|
|
|
|
|
|
|
|
|
Sandoz
International Industriestr.
|
|
|
83607
Holzkirchen,Germany
|
|
|
Tel: +49
8024 476 2596
|
|
|
Fax:
+49 8024 476 2599
|
|
|
www.sandoz.com
|
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
“potentially,”
“plan,” “expected,” “proposed,” “potential,”
“can,”
“will,”
“look forward,” “believe,”
“committed,”
“investigational,” “portfolio,”
“launch,”
or similar terms,
or
by express or implied discussions
regarding
potential marketing
approvals,
new
indications
or
labelling
for the investigational or approved
biosimilar
products described in
this
press release, or regarding potential future
revenues
from Hyrimoz
and
such other biosimilar 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 Hyrimoz
or the other investigational or approved
biosimilar
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.
Neither
can there be any guarantee
that,
if
approved, such other biosimilar products will be approved for all
indications
included
in
the reference product’s label. Nor can there be any guarantee that
Hyrimoz or such
other
products will be commercially successful
in
the future.
In
particular, our expectations regarding Hyrimoz and such
other
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; the
particular
prescribing preferences of
physicians
and patients; competition
in
general, including potential approval of additional biosimilar
versions
of such
products; global
trends
toward health care cost containment, including government,
payor
and general public
pricing and reimbursement pressures;
litigation
outcomes,
including
intellectual property disputes or
other
legal efforts to
prevent
or limit Sandoz from
selling its
products; 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
Sandoz
Sandoz
is
a global
leader
in
generic
pharmaceuticals
and
biosimilars.
As
a division of
the
Novartis Group,
our purpose
is
to discover new
ways
to improve and extend people’s lives.
We
contribute
to
society’s
ability to support growing healthcare needs by
pioneering
novel approaches to
help
people around the
world
access high-quality medicine. Our
portfolio of
approximately 1,000 molecules, covering
all major
therapeutic
areas, accounted for 2017 sales of
USD
10.1 billion. In 2017, our products reached well
over 500
million patients. Sandoz
is
headquartered
in
Holzkirchen,
in
Germany’s
Greater Munich area.
Sandoz
is
on Twitter. Sign up to
follow
@Sandoz_global at
http://twitter.com/Sandoz_Global
.
Follow our blog at
www.sandoz.com/makingaccesshappen
.
|
|
|
|
Media
Release
|
Medienmitteilung
|
Communiqué Aux Médias
|
|
|
|
|
|
|
|
|
Sandoz
International Industriestr.
|
|
|
83607
Holzkirchen,Germany
|
|
|
Tel: +49
8024 476 2596
|
|
|
Fax:
+49 8024 476 2599
|
|
|
www.sandoz.com
|
References:
|
1.
|
European Medicines
Agency.
Hyrimoz. Key Facts. Available
at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004320/s mops/Positive/human_smop_001301.jsp&mid=WC0b01ac058001d127&source=homeMedSe
arch&category=human
. Accessed
June
19, 2018.
|
|
2.
|
European Medicines
Agency.
Hyrimoz. Summary of
Product Characteristics:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004320/s
mops/Positive/human_smop_001301.jsp&mid=WC0b01ac058001d127
.
|
|
3.
|
European Medicines Agency.http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/1
2/news_detail_002667.jsp&mid=WC0b01ac058004d5c1. Accessed July 5, 2018.
|
|
4.
|
European Commission Consensus paper –
What
you
need to know about biosimilar medicines:
http://ec.europa.eu/DocsRoom/documents/8242
.
Accessed July 2, 2018.
|
|
5.
|
Blauvelt A.
A randomized, double-blind, multicenter
study to compare
the
efficacy,
safety,
and immunogenicity of a proposed adalimumab
biosimilar
(GP2017)
with
originator adalimumab
Poster
#5224 presented
at
the 2017 American Academy of Dermatology (AAD) Annual Meeting,
3-7
March 2017.
|
|
6.
|
Blauvelt A.
Long-Term
Efficacy,
Safety
and
Immunogenicity Results from a
Randomized,
Double-Blind,
Phase
III
Confirmatory Efficacy and Safety Study Comparing GP2017,
a
Proposed
Biosimilar,
with
Reference
Adalimumab [abstract].
Arthritis
Rheumatol. 2017; 69 (suppl 10). American College
of Rheumatology (ACR) Annual Meeting, US,
3-9
November 2017.
|
|
7.
|
Jauch-Lembach J.
Randomized,
Double-Blind, Single-Dose,
Three-Arm
Parallel
Trial to Determine
the
Pharmacokinetics and Safety of GP2017,
EU-
and
US-Adalimumab
in
Healthy Male Subjects [abstract].
Arthritis
Rheumatol.
2017;
69 (suppl 10). American College of Rheumatology (ACR) Annual Meeting,
US, 3-9
November
2017.
|
†
Humira
®
(adalimumab)
is
marketed by AbbVie Deutschland
GmbH
& Co.
KG in
Europe and Humira
®
is
a registered trademark
of
AbbVie
Biotechnology,
Inc.
*Hyrimoz
is
only
available
as 40
mg
pre-filled syringe
/ pre-filled pen. Thus,
it is
not
possible
to administer Hyrimoz to pediatric patients that require less
than
a full 40
mg
dose.
If an alternate dose
is required,
other adalimumab products offering such an option should be used.
**European Commission
decisions
on the authorization
of
medicines are
valid
throughout the 31
countries
of
the
European
Economic area,
which
comprises
the
28
member
countries
of
the
European
Union
plus Norway,
Iceland and
Liechtenstein. That
governing
body bases its decisions on scientific assessments by
the Committee for Medicinal Products for Human Use (CHMP), a subgroup
of the
European
Medicines Agency
(EMA).
# # #
Novartis Media
Relations
Central media line:
+41
61
324
2200
E-mail:
media.relations@novartis.com
Eric
Althoff
Novartis
Global Media
Relations
+41
61
324
7999 (direct)
+41 79
593
4202 (mobile)
eric.althoff@novartis.com
|
|
|
|
Media
Release
|
Medienmitteilung
|
Communiqué Aux Médias
|
|
|
|
|
|
|
|
|
Sandoz
International Industriestr.
|
|
|
83607
Holzkirchen,Germany
|
|
|
Tel: +49
8024 476 2596
|
|
|
Fax:
+49 8024 476 2599
|
|
|
www.sandoz.com
|
Chris Lewis
|
Michelle Bauman
|
Sandoz Global Communications
|
Sandoz Global Communications
|
+49
174
244 9501 (mobile)
|
+1 973 714 8043 (mobile)
|
chris.lewis@sandoz.com
|
michelle.bauman@sandoz.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
|
+1 212 830
2448
|
Pierre-Michel
Bringer
|
+41
61
324
1065
|
Cory Twining
|
+1 212 830
2417
|
Thomas Hungerbuehler
|
+41
61
324
8425
|
|
|
Isabella
Zinck
|
+41
61
324
7188
|
|
|
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.
|
Novartis AG
|
|
|
|
|
|
|
|
|
|
Date: July 27, 2018
|
By:
|
/s/ PAUL
PENEPENT
|
|
|
Name:
|
Paul Penepent
|
|
|
Title:
|
Head Group Financial Reporting and
Accounting
|
Novartis Ag Basel Namen ... (PK) (USOTC:NVSEF)
Historical Stock Chart
From Jun 2024 to Jul 2024
Novartis Ag Basel Namen ... (PK) (USOTC:NVSEF)
Historical Stock Chart
From Jul 2023 to Jul 2024