- Focused medicines company delivering strong operational
performance
- Building depth in five core therapeutic areas, strength in
technology platforms, and a balanced geographic footprint
- Confident to grow sales 4%+ CAGR through 2026*, driven by
multi-billion dollar sales from Cosentyx®, Entresto®, Kesimpta®,
Zolgensma®, Kisqali® and Leqvio®**
- Up to 20 new assets with >1-billion dollar sales potential,
set to potentially be approved by 2026, to fuel further growth
through 2030 and beyond
- Cosentyx met primary efficacy endpoint in two hidradenitis
suppurativa Ph3 studies, and ianalumab demonstrated efficacy in
Ph2b Sjögren’s study1
- Next-generation T-Charge™ platform validated as YTB323 showed
75% CR at 3 months in DLBCL2 and PHE885 delivered 100% BOR in
multiple myeloma3
- Pioneering shift to advanced technology platforms including:
Targeted Protein Degradation, Cell Therapy, Gene Therapy,
Radioligand Therapy, and xRNA
Basel, December 2, 2021 —
Novartis today holds an investor event to provide a comprehensive
overview of the company’s progress in advancing its
industry-leading R&D engine.
Vas Narasimhan, CEO of Novartis, said “Novartis
has transformed to become a focused medicines company, building
depth in our core therapeutic areas and strength across key
technology platforms. We expect to continue delivering strong
operational performance, with 4%+ CAGR through to 2026*, driven by
the momentum of our multi-billion dollar in-market growth drivers.
Up to 20 new assets with significant sales potential could be
approved by 2026, which will fuel the next phase of growth and
address major unmet needs. We are building the foundation for
long-term differential growth by investing in advanced technology
platforms and data science. Novartis remains disciplined and
shareholder focused in its capital allocation priorities, as we
continue to deliver on our strategy”.
New announcements at R&D Day 2021:
Cosentyx, our largest
medicine by sales, showed topline results in moderate to severe
hidradenitis suppurativa (HS), a potential new indication.
Two Phase 3 studies (SUNRISE and SUNSHINE) met their primary
endpoint, with more patients treated with Cosentyx achieving a HS
Clinical Response (HiSCR), compared with placebo, at week 16. The
safety of Cosentyx in HS was consistent with the therapy’s known
safety profile. The trials are ongoing to 52 weeks and are expected
to complete in H2 2022. Regulatory filings are planned for
2022.
Novartis presents T-Charge™, a
next generation CAR-T cell therapy platform, expected to increase
CAR-T potency and have important process efficiencies to reduce
turnaround time. In first-in-human trials to be presented at ASH
2021, lead candidates YTB323 and PHE885 showed 75% Complete
Response in Diffuse Large B-Cell Lymphoma (DLBCL) at three months
and 100% Best Overall Response (BOR) in multiple myeloma,
respectively. Novartis is developing T-Charge™ as the foundational
platform for a wave of potentially transformative CAR-T cell
therapies.2,3
Phase 3 study starts planned or ongoing across 5 core
therapeutic areas include:
- Cardio-Renal: Leqvio (CVRR-LDL-C), pelacarsen
(CVRR-Lp(a)), iptacopan (C3G; IgAN)
- IHD: Cosentyx (HS; GCA; lupus nephritis),
ligelizumab (CSU; food allergy; CINDU), ianalumab (Sjögren’s
syndrome), remibrutinib (CSU)
- Neuroscience: Zolgensma (SMA IT),
remibrutinib (MS)
- Oncology: Kisqali (HR+/HER2- BC adjuvant),
177Lu-PSMA-617 (mCRPC, pretaxane; mHSPC), canakinumab (adjuvant
NSCLC), NIS793 (PDAC), JDQ443 (NSCLC, 2/3L)
- Hematology: Iptacopan (aHUS; PNH), Scemblix®
(CML 1L), sabatolimab (HR-MDS), and YTB323 (2L DLBCL)
(for abbreviations, see below)
Novartis announces a global
co-development and co-commercialization agreement with UCB to
bring disease-modifying therapies to people living with Parkinson’s
Disease. The agreement covers UCB0599, a potential
first-in-class, small molecule, alpha-synuclein misfolding
inhibitor currently in Phase 2 clinical development. In addition,
upon completion of the ongoing Phase 1 program, there is an opt-in
to co-develop UCB7853, an anti-alpha-synuclein antibody. Both
assets could transform care for 10 million people living with
Parkinson’s Disease worldwide given the lack of disease-modifying
therapies.4,5
Novartis also provides a comprehensive
overview of its mid- and late-stage pipeline assets in
five core therapeutic areas, highlighting: Leqvio, pelacarsen,
iptacopan, Cosentyx, ligelizumab, remibrutinib, ianalumab, LNA043,
branaplam, Zolgensma, Kisqali, 177Lu-PSMA-617, sabatolimab, JDQ443,
TNO155, Scemblix and NIS793.
Additionally, Novartis highlights the continued
expansion of its pipeline and capabilities in advanced
technology platforms that are expected to drive multiple
waves of biopharmaceutical innovation. These include: T-Charge™,
Targeted Protein Degradation, Cell Therapy, Gene Therapy,
Radioligand Therapy and xRNA.
DisclaimerThis 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
“potential,” “can,” “will,” “could,” “expect,” “pipeline,”
“continued,” “continue,” “strategy,” “drive,” “deliver,” “remains,”
“innovation,” “pioneering,” “expected,” “mid- to long-term,”
“confident,” “to grow,” “to fuel,” “growth,” “progress,”
“potential,” or similar terms, or by express or implied discussions
regarding potential marketing approvals, new indications or
labeling for the investigational or approved products described in
this press release; or regarding potential future revenues from
such products; or regarding Cosentyx topline results in a new
indication; or regarding the global co-development and
co-commercialization agreement between Novartis and UCB; or
regarding current and potential future or pending collaborations
and alliances; or regarding T-Charge, a next generation CAR-T cell
therapy platform being developed by Novartis. 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 the
investigational or approved 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. Nor can there be any guarantee that such products
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; the potential that the strategic benefits,
synergies or opportunities expected from the collaborations or
alliances described, may not be realized or may be more difficult
or take longer to realize than expected; 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 NovartisNovartis 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 108,000 people of more than 140 nationalities
work at Novartis around the world. Find out more
at https://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at
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multimedia content, please visit
https://www.novartis.com/news/media-libraryFor
questions about the site or required registration, please contact
media.relations@novartis.com* 2020 – 2026 CAGR calculated vs. 2020
base year.**Product and brand name are currently under FDA
review.
Abbreviations
CVRR-LDL-C - Cardiovascular risk reduction - LDL-C; CVRR-Lp(a) -
Cardiovascular risk reduction - Lp(a); C3G - Complement 3
glomerulopathy; IgAN - IgA nephropathy; HS - Hidradenitis
suppurativa; GCA - Giant cell arteritis; CSU - Chronic
spontaneous urticaria; CINDU - Chronic inducible
urticaria; SMA IT - Spinal muscular atrophy - Intrathecal; MS
- Multiple sclerosis; HR+/HER2- BC - Hormone receptor positive/
human epidermal growth factor receptor 2 positive breast cancer;
mCRPC - Metastatic castration-resistant prostate cancer; mHSPC -
Metastatic hormone-sensitive prostate cancer; NSCLC - Non-small
cell lung cancer; PDAC - Pancreatic ductal adenocarcinoma; aHUS -
Atypical hemolytic uremic syndrome; PNH - Paroxysmal nocturnal
hemoglobinuria; CML - Chronic myelogenous leukemia; HR-MDS -
Higher-risk myelodysplastic syndromes; DLBCL - Diffuse large B-cell
lymphomaReferences
- Smolen J, Nash P, Tahir H, Schulze-Koops H, Li L, Hojnik M,
Gellett A, Liu-Leage S, Pillai S, Mease P. Ianalumab (VAY736), a
Dual Mode of Action Biologic Combining BAFF Receptor Inhibition
with B Cell Depletion, for Treatment of Primary Sjögren’s Syndrome:
Results of an International Randomized, Placebo Controlled Dose
Range Finding Study in 190 Patients [abstract]. Arthritis
Rheumatol. 2019; 71 (suppl 10).
https://acrabstracts.org/abstract/ianalumab-vay736-a-dual-mode-of-action-biologic-combining-baff-receptor-inhibition-with-b-cell-depletion-for-treatment-of-primary-sjogrens-syndrome-results-of-an-international-randomized/.
Accessed November 2021.
- Flinn, I. et al. A First-in-Human Study of YTB323, a Novel,
Autologous CD19-Directed CAR-T Cell Therapy Manufactured Using the
Novel T-Charge platform, for the Treatment of Patients (Pts) with
Relapsed/Refractory (r/r) Diffuse Large B-Cell Lymphoma (DLBCL).
Oral Presentation #740. 2021 American Society of Hematology (ASH)
Annual Meeting, Dec 11-14, Atlanta, GA and Virtual.
- Sperling, A. et al. Phase I Study of PHE885, a Fully Human
BCMA-Directed CAR-T Cell Therapy for Relapsed/Refractory Multiple
Myeloma Manufactured in<2 days Using the T-Charge. Poster #3864.
2021 American Society of Hematology (ASH) Annual Meeting, Dec
11-14, Atlanta, GA and Virtual.
- Parkinson’s Foundation. Parkinson’s Disease Statistics.
https://www.parkinson.org/Understanding-Parkinsons/Statistics.
Accessed November 2021.
- Parkinson’s Foundation. Parkinson’s Disease Treatment.
https://www.parkinson.org/Understanding-Parkinsons/Treatment.
Accessed November 2021.
# # #
Novartis Media RelationsE-mail:
media.relations@novartis.com
Richard JarvisNovartis
Strategy & Financial Comms+41 79 584 23 26
(mobile)richard.jarvis@novartis.com |
Julie MasowNovartis US
External Engagement+1 862 579 8456Julie.masow@novartis.com |
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relations line: +41 61 324 7944E-mail:
investor.relations@novartis.com
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