finanzen.net
13.09.2019 14:15
Bewerten
(0)

Novartis Phase III ASCLEPIOS trials demonstrate robust efficacy of ofatumumab in patients with relapsing multiple sclerosis

  • Both ASCLEPIOS I and II studies met their primary endpoints in patients with relapsing forms of MS (RMS)[1]; overall ofatumumab (OMB157), a subcutaneous, potent, fully-human antibody targeting CD20 positive B-cells, delivered efficacy with a favorable safety profile[1]
     
  • RMS patients on ofatumumab had a reduction in annualized relapse rate (ARR) by 50.5%  (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25) compared to Aubagio®* (teriflunomide) (both studies p<0.001) in ASCLEPIOS I and II studies respectively[1]
     
  • Ofatumumab showed highly significant suppression of gadolinium (Gd) T1 lesions when compared to Aubagio®, demonstrating a profound suppression of new inflammatory activity[1]
     
  • Ofatumumab showed a relative risk reduction of 34.4% in 3-month confirmed disability progression (CDP) (p=0.002) and 32.5% in 6-month CDP (p=0.012) versus Aubagio® in pre-specified pooled analyses[1]
     
  • Ofatumumab, if approved, will potentially become a treatment for a broad RMS population and the first B-cell therapy that is easy to start and manage in a monthly self-administered injection at home

Basel, September 13, 2019 Novartis, a global leader in neuroscience, today presented positive results of the Phase III ASCLEPIOS I and II studies at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden. Data from both studies show ofatumumab (OMB157) was superior to Aubagio®* (teriflunomide) in patients with relapsing forms of MS (RMS)[1]. The ASCLEPIOS I and II studies are twin, identical design, flexible duration (up to 30 months), double-blind, randomized, multi-center Phase III studies evaluating the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections versus Aubagio® 14mg oral tablets taken once daily in adults with RMS[2],[3].

Both studies met the primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR)[1]. Patients treated with ofatumumab had an ARR of 0.11 and 0.10 compared to Aubagio® (ARR of 0.22 and 0.25) in ASCLEPIOS I and II respectively, corresponding to a reduction in ARR by 50.5% and 58.8% with ofatumumab (p<0.001 in both studies)[1]. Ofatumumab showed highly significant suppression of both Gd+ T1 lesions and new or enlarging T2 lesions compared to Aubagio®, demonstrating a profound suppression of new inflammatory activity[1]. Additionally, ofatumumab showed a relative risk reduction of 34.4% (p=0.002) in 3-month confirmed disability progression (CDP) and 32.5% (p=0.012) in 6-month CDP versus Aubagio® in pre-specified pooled analyses[1]. Overall ofatumumab, a potent, fully-human antibody targeting CD20 positive B-cells, delivered efficacy with a favorable safety profile[1]. The safety profile of ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results[1],[4]. Novartis plans to initiate submissions to health authorities by end of 2019.

"It is clear that early initiation of highly effective treatment for MS improves long-term outcomes, and there is great need for potent, safe, and convenient therapy that can be used to treat MS from the start,” said Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences. "The results from ASCLEPIOS are wonderful news for patients who would like to take an extremely effective B-cell therapy with low requirement for monitoring, avoiding visits to an infusion center.”

"Ofatumumab showed high efficacy and a favorable safety profile in people with RMS, offering a potential first B-cell therapy that can be self-administered in the home,” said John Tsai, Head of Global Drug Development and Chief Medical Officer, Novartis. "This is a big step forward in our relentless efforts to advance and reimagine treatment in the MS journey of each patient.”  

The ASCLEPIOS I and II studies enrolled 1,882 patients with MS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.5[2],[3]. The studies were conducted in over 350 sites in 37 countries. Additional secondary endpoints included confirmed disability improvement at 6 months, serum levels of neurofilament light chain (NfL), and rate of brain volume loss[2],[3]. Safety and the pharmacokinetic properties of ofatumumab were also measured throughout the treatment period[2],[3].

About ofatumumab
Ofatumumab is a fully human anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly subcutaneous injection that is in development for MS. Ofatumumab works by binding to the CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion. Positive Phase IIb results in MS patients were presented in 2014 and showed a marked significant reduction in the number of new brain lesions in the first 24 weeks after ofatumumab administration[4]. Novartis initiated a Phase III program for ofatumumab in RMS in August 2016. Novartis obtained rights for ofatumumab from Genmab in all indications, including MS, in December 2015. Novartis released first interpretable results from the ASCLEPIOS studies at the end of August 2019.

About Multiple Sclerosis
MS disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss[5]. MS, which affects approximately 2.3 million people worldwide[6], is often characterized into three forms: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS – often defined as cognitive and physical changes, and an overall accumulation of disability[7]) and primary progressive MS (PPMS)[8]. Approximately 85% of patients initially present with relapsing forms of MS[6].

About Novartis in MS
The Novartis multiple sclerosis portfolio includes Gilenya® (fingolimod, an S1P modulator), which is indicated in European Union for the treatment of adult patients and children and adolescents 10 years of age and older with RMS. In the United States, Gilenya is approved for the treatment of adults with relapsing forms of MS, to include clinically isolated syndrome (CIS), relapsing remitting disease and active secondary progressive disease.

In March 2019, the US Food and Drug Administration approved Mayzent® (siponimod) for the treatment of relapsing forms of MS, to include CIS, relapsing remitting disease and active secondary progressive disease. The approval is based on the Phase III EXPAND trial, the largest controlled clinical study of SPMS patients, showing Mayzent significantly reduced the risk of disease progression, including impact on physical disability and cognitive decline[9]. Novartis is committed to bringing Mayzent to patients worldwide, and additional regulatory filings are currently underway with other health authorities outside the US for secondary progressive MS.

Extavia® (interferon beta-1b for subcutaneous injection) is approved in the US for relapsing forms of MS, to include CIS, relapsing remitting disease and active secondary progressive disease. In Europe, Extavia is approved to treat people with RRMS, SPMS with active disease and people who have had a single clinical event suggestive of MS.

In the US, the Sandoz Division of Novartis markets Glatopa® (glatiramer acetate injection) 20mg/mL and 40mg/mL, generic versions of Teva's glatiramer acetate.

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 "potential,” "can,” "will,” "plan,” "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 press release, 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 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; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality 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 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 more than 750 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 www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis or follow @NovartisNews for the latest News & Media Updates at https://twitter.com/novartisnews
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

*Aubagio® is a registered trade mark of Genzyme, a Sanofi company.
CDP synonymously used for confirmed disability worsening (CDW).
Clinically isolated syndrome (CIS) is defined as a first episode of neurologic symptoms that lasts at least 24 hours and is caused by inflammation or demyelination in the central nervous system[10].

References
[1]            Hauser S. Efficacy and safety of ofatumumab versus teriflunomide in relapsing multiple sclerosis: results of the phase 3 ASCLEPIOS I and II trials. Oral presentation. ECTRIMS 2019.
[2]            ClinicalTrials.gov. Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I). https://clinicaltrials.gov/ct2/show/NCT02792218. Accessed September 2019.
[3]            ClinicalTrials.gov. Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. (ASCLEPIOS II). https://clinicaltrials.gov/ct2/show/NCT02792231. Accessed September 2019.
[4]            Bar-Or A, et al. Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study. Neurology. 2018; 90(20):e1805–1814.
[5]            John Hopkins Medicine. Multiple sclerosis (MS). https://www.hopkinsmedicine.org/neurology_neurosurgery/centers_clinics/multiple_sclerosis/conditions/index.html. Accessed September 2019.
[6]            Multiple Sclerosis International Federation. Atlas of MS 2013. http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf. Accessed September 2019.
[7]            National Multiple Sclerosis Society. Secondary Progressive MS (SPMS). https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Secondary-progressive-MS. Accessed September 2019.
[8]            Multiple Sclerosis International Federation. Types of MS. https://www.msif.org/about-ms/types-of-ms/. Accessed September 2019.
[9]            Kappos L, Cree B, Fox R, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomized, phase 3 study. Lancet. 2018:391(10127):1263-1273.
[10]          National MS Society. Clinically isolated syndrome (CIS). https://www.nationalmssociety.org/Symptoms-Diagnosis/Clinically-Isolated-Syndrome-(CIS). Accessed September 2019.

# # #

Novartis Global External Communications
E-mail: media.relations@novartis.com

 
 
Antonio Ligi
Novartis External Communications
+41 79 723 3681 (mobile)
antonio.ligi@novartis.com

 

Eric Althoff
Novartis US External Communications
+1 646 438 4335
eric.althoff@novartis.com
Friedrich vonHeyl
Novartis Global Pharma Communications
+41 61 324 8984(direct)
+41 79 749 0286 (mobile)
friedrich.vonheyl@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 7944Sloan Simpson+1 862 778 5052
Pierre-Michel Bringer+41 61 324 1065Cory Twining +1 862 778 3258
Thomas Hungerbuehler+41 61 324 8425  
Isabella Zinck+41 61 324 7188  

 

Nachrichten zu Novartis AG

  • Relevant
    1
  • Alle
    2
  • vom Unternehmen
  • Peer Group
  • ?

Um Ihnen die Übersicht über die große Anzahl an Nachrichten, die jeden Tag für ein Unternehmen erscheinen, etwas zu erleichtern, haben wir den Nachrichtenfeed in folgende Kategorien aufgeteilt:

Relevant: Nachrichten von ausgesuchten Quellen, die sich im Speziellen mit diesem Unternehmen befassen

Alle: Alle Nachrichten, die dieses Unternehmen betreffen. Z.B. auch Marktberichte die außerdem auch andere Unternehmen betreffen

vom Unternehmen: Nachrichten und Adhoc-Meldungen, die vom Unternehmen selbst veröffentlicht werden

Peer Group: Nachrichten von Unternehmen, die zur Peer Group gehören

Analysen zu Novartis AG

  • Alle
  • Buy
  • Hold
  • Sell
  • ?
07.10.2019Novartis NeutralUBS AG
07.10.2019Novartis UnderweightJP Morgan Chase & Co.
07.10.2019Novartis Conviction Buy ListGoldman Sachs Group Inc.
04.10.2019Novartis UnderweightJP Morgan Chase & Co.
17.09.2019Novartis Conviction BuyGoldman Sachs Group Inc.
07.10.2019Novartis Conviction Buy ListGoldman Sachs Group Inc.
17.09.2019Novartis Conviction BuyGoldman Sachs Group Inc.
13.09.2019Novartis Conviction BuyGoldman Sachs Group Inc.
13.09.2019Novartis buyMerrill Lynch & Co., Inc.
30.08.2019Novartis Conviction Buy ListGoldman Sachs Group Inc.
07.10.2019Novartis NeutralUBS AG
16.09.2019Novartis HoldDeutsche Bank AG
10.09.2019Novartis NeutralUBS AG
09.09.2019Novartis HoldDeutsche Bank AG
30.08.2019Novartis HoldDeutsche Bank AG
07.10.2019Novartis UnderweightJP Morgan Chase & Co.
04.10.2019Novartis UnderweightJP Morgan Chase & Co.
09.09.2019Novartis UnderweightJP Morgan Chase & Co.
05.09.2019Novartis UnderweightBarclays Capital
28.08.2019Novartis UnderweightJP Morgan Chase & Co.

Um die Übersicht zu verbessern, haben Sie die Möglichkeit, die Analysen für Novartis AG nach folgenden Kriterien zu filtern.

Alle: Alle Empfehlungen

Buy: Kaufempfehlungen wie z.B. "kaufen" oder "buy"

Hold: Halten-Empfehlungen wie z.B. "halten" oder "neutral"

Sell: Verkaufsempfehlungn wie z.B. "verkaufen" oder "reduce"
mehr Analysen
Werbung
Werbung
Börse Stuttgart Anlegerclub

Die richtige Strategie für die Börsenkrise

Stecken Sie nicht den Sand in den Kopf, sondern kaufen Sie die richtigen Aktien. Erfahren Sie im aktuellen Anlegermagazin mehr über attraktive Qualitätsaktien und zyklische Aktien
Kostenfrei registrieren und lesen!

Heute im Fokus

DAX geht etwas schwächer aus dem Handel -- Facebook verliert erneut namhafte Partner für Libra-Projekt -- Daimler erhält weiteren Rückruf-Bescheid des KBA -- AIXTRON, Rheinmetall, K+S, FMC im Fokus

Bayer bekommt weitere US-Zulassung für Gerinnungshemmer Xarelto. INDUS-Aktien knicken nach Gewinnwarnung ein. TOTAL beteiligt sich an indischer Adani Gas. Chinas Außenhandel im September schwächer als erwartet. Liberty will sich an Sunrise beteiligen. Faurecia will SAS-JV mit Continental komplett übernehmen.

Die 5 beliebtesten Top-Rankings

In diesen Berufen bekommt man das höchste Gehalt
Mit welchem Beruf kommt man am ehesten an die Spitze?
Big-Mac-Index
In welchen Ländern kostet der Big Mac wie viel?
Das sind die bestbezahlten Schauspieler 2019
Wer verdiente am meisten?
Die Performance der Rohstoffe in in Q3 2019.
Welcher Rohstoff macht das Rennen?
Die Performance der TecDAX-Werte in Q3 2019.
Welche Aktie macht das Rennen?
mehr Top Rankings

Umfrage

Die Bundesregierung erlaubt anscheinend Huawei-Technik bei Aufbau des 5G-Netzes. Was halten Sie davon?

Online Brokerage über finanzen.net

finanzen.net Brokerage
Handeln Sie für nur 5 Euro Orderprovision* pro Trade aus der Informationswelt von finanzen.net!

ETF-Sparplan

Oskar ist der einfache und intelligente ETF-Sparplan. Er übernimmt die ETF-Auswahl, ist steuersmart, transparent und kostengünstig.
Zur klassischen Ansicht wechseln
Kontakt - Impressum - Werben - Pressemehr anzeigen
Top News
Beliebte Suchen
DAX 30
Öl
Euro US-Dollar
Bitcoin
Goldpreis
Meistgesucht
Wirecard AG747206
Daimler AG710000
Deutsche Bank AG514000
NEL ASAA0B733
Microsoft Corp.870747
Apple Inc.865985
Volkswagen (VW) AG Vz.766403
Amazon906866
CommerzbankCBK100
SAP SE716460
Infineon AG623100
BASFBASF11
TUITUAG00
Aurora Cannabis IncA12GS7
Allianz840400