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2016-12-07

Novartis International AG: Novartis' Lucentis® received EU approval in new indication - Lucentis the only treatment available for a wide range of CNV condition

Novartis International AG / Novartis' Lucentis® received EU approval in new
indication - Lucentis the onlytreatment available for a wide range of CNV
conditions . Processed and transmitted by Nasdaq Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
* The European Commission approved Lucentis to treat patients for visual
impairment due to choroidal neovascularization (CNV) associated with causes
other than neovascular age-related macular degeneration (nAMD) or secondary
to pathologic myopia (PM)
* Results of the pivotal MINERVA[5]study showed a significant gain in visual
acuity of approximately 10 letters at two months, which was maintained for
one year[1]
* Lucentis (ranibizumab) is the first and only treatment approved in this
indication in the EU, and the only treatment available for a wide range of
CNV conditions

Basel, December 7, 2016
-
Novartis today announced that the European Commission (EC) has granted an
additional indication for Lucentis®(ranibizumab) to treat patients with
visual impairment due to choroidal neovascularization (CNV) associated with
causes other than neovascular age-related macular degeneration (nAMD), or
secondary to pathologic myopia (PM). With this approval, Lucentis is the
first retinal treatment approved for these conditions, addressing an
important unmet medical need.

"This confirms Lucentis as standard of care in diseases of the retina," said
Paul Hudson, CEO Novartis Pharmaceuticals. "With this approval, Lucentis is
the only treatment available for a wide range of CNV conditions. We are
dedicated to bringing new innovations to the market, as we are aware that
there is still high unmet medical need for patients with retinal diseases."

The approval is applicable to all 28 European member states, as well as
Iceland, Liechtenstein and Norway. It was based on the positive opinion from
the Committee for Medicinal Products for Human Use (CHMP), adopted in October
2016. Following this approval, Lucentis covers six indications in Europe.

Submissions for this indication have been filed in 11 other countries,
including Switzerland, Australia, Indonesia and Brazil.

About CNV

CNV is an ocular condition caused by the growth of abnormal blood vessels
below the retina, which cause disruption to vision[2]. The condition can
occur rapidly, and is a major cause of vision loss, causing symptoms
including visual distortion, color disturbances, partial loss of vison or a
blindspot within the visual field[3]. CNV is most commonly associated with
neovascular ("wet") age-related macular degeneration and pathologic myopia,
but it can also occur with many other conditions including uveitis, central
serous chorioretinopathy, angioid streaks, trauma, retinal or macular
dystrophies, and with no apparent cause (idiopathic CNV)[4].

About MINERVA study trial

The submission was supported by data from the Novartis sponsored MINERVA[5]
study, which showed that Lucentis treatment resulted in a significant gain of
visual acuity by approximately 10 letters at two months; this gain was
maintained to month 12 of the one-year study[1]. Ranibizumab has therefore
proven to be effective for the treatment of CNV, regardless of the underlying
etiology, with no new safety findings[1].

About Lucentis

Lucentis is a humanized therapeutic antibody fragment designed to block all
biologically active forms of vascular endothelial cell growth factor-A
(VEGF-A). Increased levels of VEGF-A are seen in nAMD and other ocular
diseases such as DME and retinal vein occlusion (RVO). Lucentis was
specifically designed for the eye, minimizing systemic exposure.

Lucentis is licensed for the treatment of nAMD, and for the treatment of
visual impairment due to CNV, DME, BRVO and CRVO. The indication for the
treatment of visual impairment due to CNV includes secondary to pathologic
myopia (PM) and CNV associated with causes other than nAMD or PM (approved in
EMA only
).

Lucentis is available in more than 110 countries and has a well-established
safety profile supported by a portfolio of 129 sponsored clinical studies in
addition to extensive real-world experience. The safety profile of Lucentis
has been well established in a clinical development program that has enrolled
more than 76,000 patients across indications and has 3.7 million
patient-treatment years of exposure since its launch in the United States in
2006. Lucentis was developed by Genentech and Novartis. Genentech has the
commercial rights to Lucentis in the United States. Novartis has exclusive
rights in the rest of the world. Lucentis is a registered trademark of
Genentech Inc.

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "dedicated to," "positive opinion," "so far," or
similar terms, or by express or implied discussions regarding potential new
indications or labeling for Lucentis, or regarding potential future revenues
from Lucentis. You should not place undue reliance on these statements. Such
forward-looking statements are based on the current beliefs and expectations
of management 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 Lucentis will be
submitted or approved for any additional indications or labeling in any
market, or at any particular time. Nor can there be any guarantee that
Lucentis will be commercially successful in the future. In particular,
management's expectations regarding Lucentis could be affected by, among
other things, the uncertainties inherent in research and development,
including unexpected clinical trial results and additional analysis of
existing clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected 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.

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, eye care and cost-saving generic pharmaceuticals. Novartis is the
only global company with leading positions in these areas. In 2015, the Group
achieved net sales of USD 49.4 billion, while R&D throughout the Group
amounted to approximately USD 8.9 billion (USD 8.7 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 118,000 full-time-equivalent associates. Novartis products are
available in approximately 180 countries around the world. For more
information, please visithttp://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis
athttp://twitter.com/novartis

For Novartis multimedia content, please
visitwww.novartis.com/news/media-library

For questions about the site or required registration, please
contactmedia.relations@novartis.com

References

[1] Lai, T et al. Efficacy and safety of ranibizumab 0.5 mg in adult patients
with visual impairment due to choroidal neovascularization associated with
rare diseases: 12 month results of the MINERVA study. European Society of
Retina Specialists (EURETINA) 2016.
[2] American Academy of Ophthalmology. What Are Choroidal Neovascular
Membranes? Available
athttp://www.aao.org/eye-health/diseases/choroidal-neovascular-membranes.
Accessed October 2016.

[3] American Academy of Ophthalmology. Choroidal Neovascular Membranes
Symptoms. Available
athttp://www.aao.org/eye-health/diseases/choroidal-neovascular-membranes-s....
Accessed October 2016.

[4] Cohen S et al. Etiology of choroidal neovascularization in young patients.
Ophthalmology 1996; 103: 1241-1244.
[5] ClinicalTrials.gov. Identifier NCT01840410. Available
athttps://clinicaltrials.gov/ct2/show/study/NCT01840410. Accessed October
2016.

# # #

Novartis Media Relations

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

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Media release (PDF)
http://hugin.info/134323/R/2062345/773704.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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