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Novartis highlights its differentiated late stage pipeline at the R&D update and investor event

Novartis International AG /
Novartis highlights its differentiated late stage pipeline at the R&D update and
investor event
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.

* RTH258 demonstrates superiority versus aflibercept in key secondary endpoint
measures of disease activity and meets primary endpoint of non-inferiority
in patients with nAMD

* AMG 334 has a robust data package, even in difficult to treat patients, and
is on track to be the first CGRP to market for treatment of patients with
chronic or episodic migraine

* Cosentyx has strong differentiation based on its unique biology, which has
been proven to deliver a high level of enthesitis resolution and no
radiographic progression in spondyloarthritis

* ACZ885 feedback from regulators supports moving forward with regulatory
submissions for treatment of patients with inflammatory CV risk

London, November 13, 2017 - Novartis has had a strong year in innovation with
several key approvals and positive trial readouts. Today Novartis holds an R&D
and investor update in London, which will provide deeper insights into key late-
stage pipeline projects. In the Oncology business unit, Novartis is pursuing
multiple indications for Kymriah, the first-in-class CAR-T therapy, and could
further strengthen the oncology pipeline if the proposed acquisition of Advanced
Accelerator Applications is closed. In the Pharmaceuticals business unit,
Novartis continues to strengthen its position in Multiple Sclerosis through
BAF312 (siponimod), OMB157 (ofatumumab) and the recent pediatric findings for
Gilenya. During the investor event Novartis will provide a deep dive on the four
selected programs below.

In Ophthalmology, RTH258 (brolucizumab) data presented at the American Academy
of Ophthalmology showed superiority versus aflibercept in key secondary
endpoints reflective of disease activity in patients with nAMD. Patients treated
with RTH258 showed fewer signs of specific disease activity than patients
treated with aflibercept. RTH258 patients showed less retinal fluids, less fluid
in the deepest part of the retina and superior reductions in retinal thickness.
Novartis expects to file for the nAMD indication by Q4 2018 and expects to start
clinical trials in DME and RVO during 2018. Additionally, RTH258 creates the
potential opportunity for Novartis to enter the attractive growing US retina
market.

In Neuroscience, AMG 334 (erenumab) is being developed to deliver an effective
and safe prophylactic treatment for patients suffering from chronic or episodic
migraine. This debilitating disease affects more than 10% of adults, mainly in
their prime working years. AMG 334 has shown encouraging results in reducing
monthly migraine days, even in difficult to treat patients. AMG 334 is a fully
human, potent, selective CGRP antagonist targeting the receptor and it was the
first CGRP antagonist to be filed in the US and EU, on track for a potential
first-in-class launch in 2018.

In Immunology, Cosentyx continues to build on its best-in-class profile, which
has demonstrated sustained control of signs and symptoms in PSO, PsA and AS.
Cosentyx has strong differentiation based on its unique biology which has shown
a high level of enthesitis resolution and no radiographic progression in
psoriatic arthritis and ankylosing spondylitis. By targeting the IL-17A pathway,
the cornerstone cytokine of enthesitis, Cosentyx has the potential to change the
course of disease in AS and PsA. Cosentyx is uniquely positioned to continue
growth in all indications, particularly in spondyloarthritis, where the segment
opportunity is larger than psoriasis.

In Cardiology, ACZ885 (canakinumab) data showed there was a significant
reduction in major adverse cardiac events, in a subpopulation of patients who
achieved hsCRP<2mg/L three months after the initial treatment. This well defined
target population is critical to establishing the product's value proposition
and commercial uptake. Feedback from FDA and EU regulators supports moving
forward with regulatory submissions for cardiovascular risk reduction, which are
planned for Q4 and onwards. The novelty of approach to reduce CV risk is
recognized by the regulators and there is interest in understanding the
relationship between hsCRP and patient response.

For background slides and webcast (audio only) please refer to the following
link: http://www.novartis.com/investors/event-calendar/index.shtml
The background slide decks will be available on Monday November 13(th), 2017.

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 "pipeline," "on track,"
"moving forward," "will," "pursuing," "could," "continues," "expects," "by Q4
2018," "during 2018," "potential," "growing," "being developed," "encouraging,"
"launch," "to build," "positioned," "opportunity," "planned," "for Q4 and
onwards," "interest in," or similar terms, or by express or implied discussions
regarding potential marketing approvals, new indications or labeling for the
investigational and approved products described in this press release, including
RTH258, AMG 334, ACZ885, BAF312, OMB157, Cosentyx, Kymriah and Gilenya, or
regarding potential future revenues from such investigational and approved
products, or by express or implied discussions regarding the potential outcome
of the tender offer for Advanced Accelerator Applications, and the potential
impact on Novartis of the proposed acquisition, including express or implied
discussions regarding potential future sales or earnings of Novartis, and any
potential strategic benefits, synergies or opportunities expected as a result of
the proposed acquisition. 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 any new products will be approved for
sale in any market, or that any new indications will be approved for any
existing products in any market, or that any approvals which are obtained will
be obtained at any particular time, or that any such products will achieve any
particular revenue levels. Neither can there be any guarantee that the
investigational or approved products described in this press release will be
commercially successful in the future. Nor can there be any guarantee that the
proposed acquisition described in this press release will be completed, or that
it will be completed as currently proposed, or at any particular time. Neither
can there be any guarantee that Novartis will achieve any particular future
financial results as a result of the proposed acquisition, or that Novartis will
be able to realize any potential strategic benefits, synergies or opportunities
as a result of the proposed acquisition. Nor can there be any guarantee that
shareholders will achieve any particular level of shareholder returns. Neither
can there be any guarantee that the Group, or any of its divisions, will be
commercially successful in the future, or achieve any particular credit rating
or financial results. In particular, our expectations 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, including
potential regulatory actions or delays relating to the completion of the
potential acquisition described in this press release, as well as potential
regulatory actions or delays with respect to the development of the products
described in this press release; the potential that the strategic benefits,
synergies or opportunities expected from the proposed acquisition may not be
realized or may take longer to realize than expected; uncertainties regarding
actual or potential legal proceedings, including, among others, potential legal
proceedings with respect to the proposed acquisition; our ability to obtain or
maintain proprietary intellectual property protection, including the ultimate
extent of the impact on Novartis of the loss of patent protection and
exclusivity on key products which commenced in prior years and will continue
this year; the particular prescribing preferences of physicians and patients;
global trends toward health care cost containment, including government, payor
and general public pricing and reimbursement pressures, such as from increased
publicity on pharmaceuticals pricing, including in certain large markets;
general economic and industry conditions, including the effects of the
persistently weak economic and financial environment in many countries;
uncertainties regarding future demand for our products; safety, quality or
manufacturing issues, 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.

Additional Information
Novartis announced October 30, 2017, that it had entered a memorandum of
understanding with Advanced Accelerator Applications (AAA) under which Novartis
intends to commence a tender offer for 100% of the share capital of AAA. The
transaction is subject to certain closing conditions.  Novartis will commence a
tender offer upon completion of works council consultation and AAA's Board of
Directors recommending the tender offer to AAA shareholders. The senior
management and Directors of AAA have, in their capacity as shareholders of AAA,
undertaken to tender their shares into the proposed tender offer. The
transaction is additionally subject to (i) the valid tender pursuant to the
tender offer of ordinary shares (including ordinary shares in the form of
American Depositary Shares) of AAA representing at least 80% of the outstanding
ordinary shares on a fully diluted basis and (ii) receipt of customary
transactional regulatory approvals and other customary closing conditions.
Until such time as the closing conditions are satisfied, Lutathera® remains
under the custody and control of AAA.  Novartis does not currently own or
control these projects and will not have the ability to influence them until
closing of the proposed acquisition of AAA which is subject to certain closing
conditions and regulatory approvals.


Lutathera® is a registered trademark of Advanced Accelerator Applications.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
121,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.

###

Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com

Eric Althoff Paul Barrett
Novartis Global Media Relations  Novartis Global Media Relations
+41 61 324 7999 (direct) +41 61 324 7999 (direct)
+41 79 593 4202 (mobile) +41 79 797 8137 (mobile)
eric.althoff@novartis.com paul.barrett@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 +1 212 830 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



Media release (PDF):
http://hugin.info/134323/R/2149080/824700.pdf



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions 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



 
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