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20.01.2020 15:31:46

Press Release: Novartis announces EU approval of Mayzent(R) (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS) with active d...

-- Mayzent(R) (siponimod) is the first and only oral treatment specifically

indicated for patients with secondary progressive multiple sclerosis

(SPMS) with active disease in Europe1

-- Mayzent addresses an unmet need for SPMS patients with active disease who,

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until now, did not have an oral treatment that has been shown to be

effective in delaying progression in this patient population

-- Approval is based on the Phase III EXPAND trial, the largest randomized

clinical study in a broad range of SPMS patients, showing Mayzent

significantly reduced the risk of disease progression, including physical

disability and cognitive decline2,3

The digital press release with multimedia content can be accessed here:

https://novartis.gcs-web.com/Novartis-announces-EU-approval-of-Mayzent-siponimod-for-adult-patients-with-secondary-progressive-multiple-sclerosis-SPMS-with-active-disease

Basel, January 20, 2020 -- Novartis today announced the European

Commission (EC) has approved Mayzent(R) (siponimod) for the treatment of

adult patients with secondary progressive multiple sclerosis (SPMS) with

active disease evidenced by relapses or imaging features of inflammatory

activity. Although every patient's MS journey is unique, up to 80% of

relapsing remitting MS (RRMS) patients will eventually transition to

SPMS(4). Mayzent addresses an unmet need for SPMS patients with active

disease who, until now, did not have an oral treatment that has been

shown to be effective in delaying progression in this patient

population. The European marketing authorization makes Mayzent the first

and only indicated oral treatment proven in SPMS patients with active

disease based on a randomized clinical trial of a broad range of SPMS

patients.

"We are delighted by the news that there is now a treatment available

for people in Europe living with active SPMS to potentially delay the

progression of this debilitating disease," said Pedro Carrascal,

President of the European MS Platform. "This treatment brings hope for

improved care and quality of life to patients who have long been

underserved."

The EC's approval is based on data from the EXPAND study, a randomized,

double-blind, placebo-controlled trial, comparing the efficacy and

safety of Mayzent versus placebo in a broad range of SPMS patients (EDSS

score 3--0--6--5 at baseline). EXPAND included a subgroup of patients

with active disease (n=779), defined as patients with relapses in the

two years prior to the study and/or presence of Gd-enhancing T1 lesions

at baseline. The baseline characteristics were similar except for signs

of activity compared to the overall population.

In the subgroup of Mayzent-treated patients with active disease, results

showed:

-- The risk of three--month and six--month confirmed disability progression

(CDP) was significantly reduced by 31% compared to placebo and by 37%

compared to placebo, respectively5.

-- Significant favorable outcomes in other relevant measures of MS disease

activity, including annualized relapse rate (ARR -- confirmed relapses),

MRI disease activity and brain volume loss (brain shrinkage)5.

Results in the overall population showed that Mayzent significantly

reduced the risk of three-month CDP (primary endpoint; 21% reduction

versus placebo, p=0.013) and meaningfully delayed the risk of six-month

CDP (26% versus placebo, p=0.0058)(2). Mayzent also has a meaningful

benefit on cognition and demonstrated clinically relevant effects on

cognitive processing speed(5).

"As the only indicated oral therapy proven for people living with SPMS

with active disease, we are pleased that the European approval of

Mayzent will help change the conversation about progressing MS and

expand possibilities for patients and their caregivers," said Max

Bricchi, Global Head, Neuroscience Franchise, Novartis Pharmaceuticals.

"Delaying progression is hugely important for people living with MS who

want to maintain independence longer and today's decision gives them a

chance to achieve this goal. We are dedicated in our mission to

reimagine medicine and enable brighter futures for people with severe

progressive diseases like MS."

Novartis is working closely with all stakeholders to ensure that

eligible European patients can start benefitting from this treatment as

quickly as possible. In March 2019, Novartis received approval from the

US Food and Drug Administration (FDA) for Mayzent for the treatment of

relapsing forms of multiple sclerosis (RMS), to include clinically

isolated syndrome (CIS*), relapsing remitting disease, and active

secondary progressive disease, in adults. In November 2019, Novartis

received approval from the Australian Therapeutic Goods Administration

(TGA) for Mayzent for adult patients with SPMS. Novartis is committed to

bringing Mayzent to patients worldwide, and additional regulatory

filings are currently underway in Switzerland, Japan, Canada and China.

About Mayzent(R) (siponimod)

Mayzent is a sphingosine 1-phosphate receptor modulator that selectively

binds to S1P1 and S1P5 receptors. In relation to the S1P1 receptor, it

prevents the lymphocytes from egressing the lymph nodes and as a

consequence, from entering the central nervous system (CNS) of patients

with MS(2). This leads to the anti-inflammatory effects of Mayzent(6).

Mayzent also enters the CNS(7,8,9) and binds to the S1P5 sub-receptor on

specific cells in the CNS, including astrocytes and oligodendrocytes and

has shown pro-remyelinating and neuroprotective effects in preclinical

models of MS(10,11,12).

In the European Union (EU), Mayzent is indicated for the treatment of

adult patients with SPMS with active disease evidenced by relapsing or

imaging features of inflammatory activity. In the US, Mayzent is

approved for the treatment of relapsing forms of MS, to include CIS*,

relapsing remitting disease and active secondary progressive disease. In

November 2019, Novartis received approval from the Australian TGA for

Mayzent for adult patients with SPMS. The approvals in the US, Australia,

and EU are based on the Phase III EXPAND trial, the largest controlled

clinical study of a broad range of SPMS patients, showing Mayzent

significantly reduced the risk of disease progression, including impact

on physical disability and cognitive decline(2). Novartis is committed

to bringing Mayzent to patients worldwide, and additional regulatory

filings are currently underway in Switzerland, Japan, Canada and China.

About the EXPAND Study(2)

EXPAND is a randomized, double-blind, placebo-controlled Phase III study,

comparing the efficacy and safety of Mayzent versus placebo in people

with SPMS with varying levels of disability, EDSS scores of 3--0--6--5.

It is the largest randomized, controlled study in SPMS to date,

including 1,651 people with a diagnosis of SPMS from 31 countries.

Mayzent demonstrated a safety profile that was overall consistent with

the known effects of S1P receptor modulation. It reduced the risk of

three-month CDP by a statistically significant 21% (p=0.013; primary

endpoint). CDP was defined as a 1-point increase in EDSS, if the

baseline score was 3--0--5--0, or a 0--5-point increase, if the baseline

score was 5--5--6--5. No significant differences were found in the Timed

25-Foot Walk Test. T2 lesion volume was reduced by 79% as compared to

placebo. Additional secondary endpoints included a relative reduction in

the ARR by 55%, and compared to placebo, more patients were free from

Gd-enhancing lesions (89% vs 67% for placebo) and from new or enlarging

T2 lesions (57% vs 37% for placebo). Additional exploratory analyses

presented at the 35(th) Congress of the European Committee for Treatment

and Research in Multiple Sclerosis (ECTRIMS), demonstrated Mayzent can

help patients keep their mobility for over four years longer on

average(13).

About Multiple Sclerosis

MS disrupts the normal functioning of the brain, optic nerves and spinal

cord through inflammation and tissue loss(14). MS, which affects

approximately 2.3 million people worldwide(4), is often characterized

into three forms: primary progressive MS (PPMS)(15),

relapsing-remitting MS (RRMS), and SPMS, which follows from an initial

RRMS course and is characterized by physical and cognitive changes over

time, in presence or absence of relapses, leading to a progressive

accumulation of neurological disability(16). Approximately 85% of

patients initially present with relapsing forms of MS(4). There remains

a high unmet need for safe and effective treatments to help delay

disability progression in SPMS with active disease (with relapses and/or

evidence of new MRI activity)(16).

About Novartis in MS

In addition to Mayzent, the Novartis MS portfolio includes also

Gilenya(R) (fingolimod, an S1P modulator), which is indicated in the EU

for the treatment of adult patients and children and adolescents 10

years of age and older with RRMS. In the United States, Gilenya is

approved for the treatment of adults and pediatric patients aged 10

years and older with RMS, to include CIS*, relapsing remitting disease

and active secondary progressive disease.

Ofatumumab (OMB157), a fully human anti-CD20 monoclonal antibody (mAb)

that targets B-cells, is in development for treating RMS. Positive Phase

III data presented in September 2019 show ofatumumab met primary

endpoints to reduce the ARR in patients with RMS(17). If approved,

ofatumumab will potentially become a treatment for a broad RMS

population and the first subcutaneous B-cell therapy that can be

self-administered at home.

Extavia(R) (interferon beta-1b for subcutaneous injection) is approved

in the US for RMS, 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

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January 20, 2020 09:32 ET (14:32 GMT)