0K9E Novartis Ag

 
TIDMNOVN 
 
 
   In ASCLEPIOS I and II, ofatumumab (OMB157) met primary endpoints to 
reduce the annualized relapse rate over Aubagio(R)* (teriflunomide) in 
patients with relapsing forms of MS (RMS)[1] 
 
 
   -- Key secondary endpoints of delaying time to confirmed disability 
      progression were also met[1];  additional secondary endpoints will be 
      presented at ECTRIMS 
 
   -- Ofatumumab, a potent, fully-human antibody targeting CD20 positive 
      B-cells, delivered sustained efficacy with a favorable safety profile[1] 
 
 
   -- Novartis plans to initiate submissions to health authorities by end of 
      2019. If approved, ofatumumab will potentially become a treatment for a 
      broad RMS population and the first B-cell therapy that can be 
      self-administered at home 
 
 
   Basel, August 30, 2019 -- Novartis, a global leader in neuroscience, 
today announced positive results for ofatumumab (OMB157) from the Phase 
III ASCLEPIOS I and II studies. In both head-to-head studies, ofatumumab 
demonstrated superiority over Aubagio(R) * (teriflunomide) in patients 
with relapsing forms of multiple sclerosis (RMS)[1]. The ASCLEPIOS 
studies investigated the efficacy and safety of monthly subcutaneous 
ofatumumab 20mg versus once daily oral Aubagio(R) 14mg in adults with 
RMS[3],[4]. 
 
   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]. 
Key secondary endpoints of delaying time to confirmed disability 
progression were also met[1]. The top line results of the Phase III 
ASCLEPIOS studies will be presented at the 35(th) Congress of the 
European Committee for Treatment and Research in Multiple Sclerosis 
(ECTRIMS), taking place September 11--13, 2019, in Stockholm, Sweden. 
Overall ofatumumab, a potent, fully-human antibody targeting CD20 
positive B-cells, delivered sustained efficacy with a favorable safety 
profile. The safety profile of ofatumumab as seen in the ASCLEPIOS 
studies is in line with the observations from Phase II results. 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 a high 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 effective B-cell therapy with low 
requirement for monitoring, avoiding visits to an infusion center." 
 
   "Ofatumumab, if approved, could be a highly attractive treatment option 
for a broad RMS patient population, including early MS," said John Tsai, 
Head Global Drug Development and Chief Medical Officer, Novartis. "The 
powerful study results are a reflection of our commitment to reimagine 
MS treatment at all stages of the disease." 
 
   About ASCLEPIOS 
 
   The ASCLEPIOS I and II studies (NCT02792218 and NCT02792231) 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(R) 14mg oral tablets taken once daily in adults with a confirmed 
diagnosis of RMS[3],[4]. The 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[3],[4]. The studies were conducted 
in over 350 sites in 37 countries. 
 
   The primary endpoint of both studies was to demonstrate that ofatumumab 
is superior to Aubagio(R) in reducing the frequency of confirmed 
relapses as evaluated by the ARR in patients treated up to 30 months[3], 
[4]. Secondary endpoints included time to disability progression 
confirmed at three and six months respectively, confirmed disability 
improvement at 6 months, gadolinium enhancing T1 lesions, number of new 
or enlarging T2 lesions, serum levels of neurofilament light chain (NfL), 
and rate of brain volume loss[3],[4]. Safety and the pharmacokinetic 
properties of ofatumumab were also measured throughout the treatment 
period[3],[4]. 
 
   About ofatumumab 
 
   Ofatumumab (OMB157) 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[5]. 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. 
 
   About Multiple Sclerosis 
 
   MS disrupts the normal functioning of the brain, optic nerves and spinal 
cord through inflammation and tissue loss[6]. MS, which affects 
approximately 2.3 million people worldwide[7], 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[8]) and primary progressive MS 
(PPMS)[9]. Approximately 85% of patients initially present with 
relapsing forms of MS[7]. 
 
   About Novartis in MS 
 
   The Novartis multiple sclerosis portfolio includes Gilenya(R) 
(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(R) 
(siponimod) for the treatment of relapsing forms of MS, to include 
clinically isolated syndrome (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[10]. 
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(R)  (interferon beta-1b for subcutaneous injection) is approved 
in the US for relapsing forms of MS, to include clinically isolated 
syndrome (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(R) 
(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. 
 
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   *Aubagio(R) is a registered trade mark of Genzyme, a Sanofi company. 
 
   (**) 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[11]. 
 
   References 
 
   [1]            Novartis, data on file. 
 
   [2]            Arneth B. Impact of B cells to the pathophysiology of 
multiple sclerosis. Journal of Neuroinflammation. 2019; 16:128. 
 
   [3]            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 
August 2019. 
 
   [4]            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 August 2019. 
 
   [5]            Bar-Or A, et al. Subcutaneous ofatumumab in patients with 
relapsing-remitting multiple sclerosis: The MIRROR study. Neurology. 
2018; 90(20):e1805--1814. 
 
   [6]            John Hopkins Medicine. Multiple sclerosis (MS). 
https://www.hopkinsmedicine.org/neurology_neurosurgery/centers_clinics/multiple_sclerosis/conditions/index.html. 
Accessed August 2019. 
 
   [7]            Multiple Sclerosis International Federation. Atlas of MS 
2013. http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf. 
Accessed August 2019. 
 
   [8]            National Multiple Sclerosis Society. Secondary 
Progressive MS (SPMS). 
https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Secondary-progressive-MS. 
Accessed August 2019. 
 
   [9]            Multiple Sclerosis International Federation. Types of MS. 
https://www.msif.org/about-ms/types-of-ms/. Accessed August 2019. 
 
   [10]          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. 
 
   [11]          National MS Society. Clinically isolated syndrome (CIS). 
https://www.nationalmssociety.org/Symptoms-Diagnosis/Clinically-Isolated-Syndrome-(CIS). 
Accessed August 2019. 
 
   # # # 
 
   Novartis Global External Communications 
 
   E-mail: media.relations@novartis.com 
 
 
 
 
Antonio Ligi                          Friedrich vonHeyl 
 Novartis External Communications      Novartis Global Pharma Communications 
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(END) Dow Jones Newswires

August 30, 2019 01:15 ET (05:15 GMT)

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