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 12, 2016
(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: ☒
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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
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MEDIA RELEASE
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COMMUNIQUE AUX MEDIAS
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MEDIENMITTEILUNG
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Novartis provides update on pegpleranib Phase III clinical
trial program in patients with neovascular age-related macular degeneration (nAMD or wet AMD)
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·
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Two pivotal Phase III studies did not show additional improvement in best corrected visual acuity (BCVA) for pegpleranib
and Lucentis (ranibizumab) combination treatment over standard of care Lucentis monotherapy
1,2
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·
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Recent Lucentis EU approval in new choroidal neovascularization (CNV) indication demonstrates Novartis’ strong commitment
to innovate and grow Lucentis (ranibizumab) as standard of care in diseases of the retina – Lucentis is the only treatment
available for a wide range of CNV conditions
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·
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Novartis continues to discover and develop next generation of treatment for neovascular age-related macular degeneration
(nAMD) patients with RTH258
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Basel, December 12, 2016 –
Novartis today announced initial topline results
from two pivotal Phase III clinical studies evaluating the safety and efficacy of pegpleranib in combination with Lucentis
®
(ranibizumab) for the treatment of neovascular age-related macular degeneration (nAMD). Studies OPH1002 and OPH1003, sponsored
by Ophthotech Corporation, did not meet the primary endpoint of superiority for the pegpleranib and ranibizumab combination therapy,
measured as best corrected visual acuity (BCVA) in terms of additional letter gains over ranibizumab monotherapy. At month 12,
patients in the pegpleranib and ranibizumab combination treatment groups showed a 10.74 letter BCVA improvement in study OPH1002
1
and a 9.91 letter BCVA improvement in study OPH1003
2
. Patients treated with ranibizumab alone showed a 9.82 letter BCVA
improvement in the OPH1002
1
study and a 10.36 letter BCVA improvement in the OPH1003
2
study.
“We are fully committed to innovate and grow Lucentis as standard of care in diseases
of the retina and to continue our research in this area. The key message from the data is that the proven efficacy of Lucentis
monotherapy was not improved by the addition of pegpleranib", said Vasant Narasimhan, Global Head, Drug Development and Chief
Medical Officer, Novartis. “Together with Ophthotech we continue to analyze the data. We are confident that underlying data
will provide further understanding and guidance on how best to help patients with this disease. Novartis continues researching
new treatment options for patients with nAMD, and we are looking forward to the phase III results of our next generation treatment
RTH258.”
Data from the OPH1002 and OPH1003 studies, including secondary and exploratory efficacy endpoints,
will be presented at a future medical meeting.
About the OPH1002 and OPH1003 studies
The OPH1002 and OPH1003 studies are both randomized, double blind, Phase III clinical trial
studies designed to evaluate the safety and efficacy of pegpleranib 1.5mg in combination with ranibizumab versus ranibizumab monotherapy
in people with subfoveal neovascular age-related macular degeneration (nAMD)
1,2
. A total of 1,248 patients over the
age of 50 were enrolled across both studies (621 patients in the OPH1002 study and 627 patients in the
Page 2 of 4
OPH1003 study)
6
and were randomized to receive either pegpleranib in combination with ranibizumab or ranibizumab alone each month up to the 12
month primary endpoint of the study
1,2
.
The primary efficacy endpoint in both studies was defined as mean change in best corrected
visual acuity (BCVA) from baseline at 12 months. A number of secondary and exploratory efficacy endpoints are currently being analyzed
across both studies
1,2
.
About nAMD
Age-related macular degeneration (AMD) is a common and degenerative eye condition caused
by damage to the macula
3
, and is globally ranked as the third most common cause
of
blindness
7
. The disease is a leading cause of vision loss in people aged over 50 years
3
and impacts
an estimated 20 to 25 million people worldwide
4
. It is the primary cause of blindness in industrialized countries
7
.
Neovascular age-related macular degeneration (nAMD or wet AMD) occurs when abnormal blood vessels form underneath the macula and
cause damage to the cells, particularly if they leak blood and fluid into the eye
8
. Without treatment, vision deteriorates
within days
8
.
About pegpleranib
Pegpleranib is a 32-mer pegylated DNA aptamer that selectively binds to PDGF-BB and PDGF-AB
homo and hetero-dimers, respectively, thereby disrupting the interaction with their cognate tyrosine kinase receptors (PDGF-BB
with PDGFR-αα, PDGFR -ββ and PDGFR-αβ; PDGF-AB with PDGFR-αα and PDGFR-αβ).
These receptors are commonly expressed on cells of mesenchymal origin such as pericytes
9-13
. In a preclinical model,
pegpleranib potently stripped neovascular pericytes from the underlying endothelial cells
14
. Pericyte stripping from
a neovascular complex may leave the underlying endothelial cells in an unprotected and vulnerable state, thereby increasing their
sensitivity to the effects of VEGF blockade
9-10,12,15-17
. Pegpleranib is currently being investigated in Phase III clinical
trials for the treatment of neovascular age-related macular degeneration (nAMD or wet AMD)
1,2,5
.
About the Ophthotech and Novartis license and commercialization agreement
In May 2014, Novartis signed a license and commercialization agreement with Ophthotech Corporation
(Ophthotech) and holds the exclusive rights to pegpleranib outside the United States. Ophthotech holds the rights to pegpleranib
in the United States.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by words
such as “commitment,” “continues,” “next generation,” “continue,” “confident,”
“will,” “committed,” “looking forward,” “being analyzed,” “being investigated,”
or similar terms, or by express or implied discussions regarding potential marketing approvals for RTH258, potential marketing
approvals for pegpleranib, alone or in combination with Lucentis, potential new indications or labeling for Lucentis, alone or
in combination with pegpleranib, or regarding potential future revenues from RTH258, pegpleranib, Lucentis, or the combination
of pegpleranib and 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 RTH258 will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee
that pegpleranib, alone or in combination with Lucentis, will be submitted or approved for sale in any market, or at any particular
time. Nor can there be any guarantee that Lucentis, alone or in combination with pegpleranib, will be submitted or approved for
any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that RTH258,
pegpleranib, Lucentis, or the combination of pegpleranib and Lucentis will be commercially successful in the future. In particular,
management’s expectations regarding RTH258, pegpleranib, Lucentis, and the combination of pegpleranib
Page 3 of 4
and 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 more than 180 countries around the world. For more
information, please visit
http://www.novartis.com
.
Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis
For Novartis multimedia content, please visit
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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ClinicalTrials.gov. Identifier NCT01944839. Available at https://clinicaltrials.gov/ct2/show/NCT01944839. Accessed October
2016.
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2.
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ClinicalTrials.gov. Identifier NCT01940900. Available at
https://clinicaltrials.gov/ct2/show/NCT01940900. Accessed October 2016.
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3.
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National Eye Institute. Facts About Age-Related Macular Degeneration. Available at https://nei.nih.gov/health/maculardegen/armd_facts.
Accessed October 2016.
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4.
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Chopdar et al. Age related macular degeneration. BMJ 2003;
326(7387): 485-488.
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5.
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ClinicalTrials.gov. Identifier: NCT01940887. Available at
https://clinicaltrials.gov/ct2/show/NCT01940887. Accessed October 2016.
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6.
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Novartis data on file.
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7.
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World Health Organization. Priority eye diseases: Age-related macular degeneration. Available at http://www.who.int/blindness/causes/priority/en/index7.html.
Accessed October 2016.
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8.
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NHS Choices. Macular Degeneration. Available at http://www.nhs.uk/Conditions/Macular-degeneration/Pages/Introduction.aspx.
Accessed October 2016.
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9.
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Benjamin LE, Hemo I, Keshet E. A plasticity window for blood vessel remodelling is defined by pericyte coverage of the preformed
endothelial network and is regulated by PDGF-B and VEGF. Development. 1998; 125:1591-1598.
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10.
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Jo N, Mailhos C, Ju M, et al. Inhibition of platelet-derived growth factor B signaling enhances the efficacy of antivascular
endothelial growth factor therapy in multiple models of ocular neovascularization. Am J Pathol. 2006; 168: 2036-2053.
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11.
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Andrae J, Gallini R, Betsholtz C. Role of platelet-derived growth factors in physiology and medicine. Genes Dev. 2008; 22:1276-1312.
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12.
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Hall AP. Review of the pericyte during angiogenesis and its role in cancer and diabetic retinopathy. Toxicol Pathol. 2006;
34:763-775.
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13.
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Fredriksson L, Li H, Eriksson U. The PDGF family: four gene products form five dimeric isoforms. Cytokine Growth Factor Rev.
2004; 15:197-204.
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14.
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Mitchell TS, Bradley J, Robinson GS, et al. RGS5 expression is a quantitative measure of pericyte coverage of blood vessels.
Angiogenesis. 2008; 11:141-151.
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Page 4 of 4
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15.
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Bergers G, Hanahan D. Modes of resistance to anti-angiogenic therapy. Nat Rev Cancer. 2008; 8:592-603.
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16.
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Erber R, Thurnher A, Katsen AD, et al. Combined inhibition of VEGF and PDGF signaling enforces tumor vessel regression by interfering
with pericyte-mediated endothelial cell survival mechanisms. FASEB J. 2004; 18:338-340.
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17.
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Carmeliet P, Jain RK. Molecular mechanisms and clinical applications of angiogenesis. Nature. 2011; 473:298-307.
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# # #
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
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Friedrich von Heyl
Novartis Pharma Communications
+41 61 324 8984 (direct)
+41 79 749 0286 (mobile)
friedrich.vonheyl@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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Richard Pulik
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+1 212 830 2448
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Pierre-Michel Bringer
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+41 61 324 1065
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Sloan Pavsner
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+1 212 830 2417
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Thomas Hungerbuehler
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+41 61 324 8425
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Isabella Zinck
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+41 61 324 7188
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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 12, 2016
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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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