Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. Switzerland
  4. Swiss Exchange
  5. Novartis AG
  6. News
  7. Summary
    NOVN   CH0012005267

NOVARTIS AG

(NOVN)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector newsMarketScreener Strategies

Novartis : Kesimpta« (ofatumumab) data show long-term preservation of IgG/IgM levels and no increased risk of serious infections in people living with multiple sclerosis

06/22/2021 | 04:35am EDT
  • New ALITHIOS data show mean immunoglobulin G (IgG) levels in people treated with Kesimptaremained unchanged over 3.5 years and mean immunoglobulin M (IgM) levels remained within the reference range1
  • Lower serum immunoglobulin levels, known to occur with other anti-CD20 therapies in MS patients, have been linked to an increased risk of infection, while immunoglobulin data with Kesimpta showed no association with risk of serious infections1, 2, 3
  • Data plan for the ALITHIOS sub-study on antibody-mediated immunity post-vaccination in Kesimpta-treated patients will be presented; data generated will provide greater understanding of how the B-cell depleting treatment will impact immune response to vaccinations1
  • Kesimpta is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in MS4

Basel, June 22, 2021 - Today, Novartis disclosed new data showing mean IgG and IgM levels remain unchanged in adults with relapsing multiple sclerosis (RMS) treated with Kesimpta® (ofatumumab) over 3.5 years. The ongoing open label extension of the ALITHIOS study includes 1,703 people living with MS taking Kesimpta for up to 5 years. At the time of analysis, 456 of these people had reached 3.5 years of Kesimpta treatment duration. The long-term findings were consistent with the Phase III ASCLEPIOS trials data, which demonstrated that the overall incidence of infections was low, and no association was observed between decreased immunoglobulin levels and the risk of serious infections1. These data reinforce Kesimpta as a well-tolerated treatment option for people living with RMS.

'Evidence shows that low immunoglobulin levels have been linked to an increased risk of infection, which is why testing of these levels is recommended for people living with MS prior to taking any anti-CD20 treatment,' said Professor Heinz Wiendl, Director of the Clinic of Neurology at UKM Münste. 'It's encouraging to see that over a long period of time, IgG levels remained stable and IgM levels remained well within the reference ranges in all groups treated with ofatumumab, with no increased risk of infections.'

The results will be presented at the 7th Congress of the European Academy of Neurology - Virtual 2021, together with other wide-ranging data to further the understanding of how Kesimpta might impact immune response to a variety of standard vaccinations.

'Patient safety is of the utmost importance to Novartis and these long-term results continue to support Kesimpta as a high-efficacy, first-choice treatment with a favorable safety profile for people living with RMS,' said Marcia Kayath, Global Head Medical Affairs, Novartis Pharmaceuticals. 'Preservation of immunoglobulin levels is important to fight infections, like COVID-19, so we're very happy to share long-term data showing Kesimpta had unchanged IgG levels, providing physicians with important information relevant to the long-term benefit/risk of treating with Kesimpta.'

Disclaimer
This media update 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,' 'plan,' 'may,' 'could,' 'would,' 'expect,' 'anticipate,' 'look forward,' 'believe,' 'committed,' 'investigational,' 'pipeline,' 'launch,' 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 media update, or regarding potential future revenues from such 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 the investigational or approved products described in this media update 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; 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

About Novartis
Novartis 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 110,000 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 https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact [email protected]

References

  1. Jasińska E, Habek M, Wynnet D, et al. Impact of Ofatumumab on Immune Responses Post-vaccination in RMS Patients: ALITHIOS Vaccination Sub-study Design. Oral presentation at: EAN 2021; June 19-22, 2021.
  2. Furst D. Serum immunoglobulins and risk of infection: how low can you go? Seminars in Arthritis and Rheumatism. 2009;39(1):18-29.
  3. Tallantyre E, Whittam D, Jolles S, et al. Secondary antibody deficiency: a complication of anti-CD20 therapy for neuroinflammation. J Neurol. 2018;265(5):1115-1122.
  4. Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med. 2020;383(6):546-557.

# # #

Novartis Media Relations
E-mail: [email protected]

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: [email protected]

Central North America
Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052
Thomas Hungerbuehler
Isabella Zinck
+41 61 324 8425
+41 61 324 7188

Disclaimer

Novartis AG published this content on 22 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 June 2021 08:34:07 UTC.


ę Publicnow 2021
All news about NOVARTIS AG
07/23NOVARTIS AG : Buy rating from UBS
MD
07/22GLOBAL MARKETS LIVE : AT&T, American Airlines, Biogen, Netflix, ABB...
07/22GLAXOSMITHKLINE : GSK appoints consumer head as CEO of new spin-off
RE
07/22NOVARTIS AG : Deutsche Bank is now Neutral
MD
07/22ANALYST RECOMMENDATIONS : Barclays, Chevron, Flutter, Netflix, Unilever...
07/22NOVARTIS AG : Credit Suisse sticks Neutral
MD
07/22NOVARTIS : ESG Update - July 22, 2021
PU
07/22NOVARTIS AG : Goldman Sachs remains its Buy rating
MD
07/21NOVARTIS AG : Bernstein sticks Neutral
MD
07/21European Stocks Close in Green On Strong Earnings
MT
More news
Financials (USD)
Sales 2021 51 974 M - -
Net income 2021 9 802 M - -
Net Debt 2021 24 182 M - -
P/E ratio 2021 20,2x
Yield 2021 3,59%
Capitalization 222 B 222 B -
EV / Sales 2021 4,74x
EV / Sales 2022 4,40x
Nbr of Employees 109 000
Free-Float 87,4%
Chart NOVARTIS AG
Duration : Period :
Novartis AG Technical Analysis Chart | NOVN | CH0012005267 | MarketScreener
Technical analysis trends NOVARTIS AG
Short TermMid-TermLong Term
TrendsNeutralBullishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 26
Last Close Price 91,20 $
Average target price 105,25 $
Spread / Average Target 15,4%
EPS Revisions
Managers and Directors
Vasant Narasimhan Chief Executive Officer
Harry Werner Kirsch Chief Financial Officer
Hans J÷rg Reinhardt Independent Non-Executive Chairman
John Tsai Chief Medical Officer
Klaus Moosmayer Chief Ethics Risk & Compliance Officer
Sector and Competitors
1st jan.Capi. (M$)
NOVARTIS AG-0.17%207 246
JOHNSON & JOHNSON9.21%432 430
ROCHE HOLDING AG12.39%325 975
PFIZER, INC.13.58%218 198
ELI LILLY AND COMPANY44.05%209 276
ABBVIE INC.9.93%199 548