Press Release: Novartis PARADIGMS data show children and adolescents with MS had an 82% lower relapse rate with Gilenya(R) vs. interferon beta-1a

Novartis International AG / Novartis PARADIGMS data show children and

adolescents with MS had an 82% lower relapse rate with Gilenya(R) vs.

interferon beta-1a. Processed and transmitted by Nasdaq Corporate

Solutions. The issuer is solely responsible for the content of this

announcement.

-- PARADIGMS data also show patients treated with Gilenya had significantly

fewer new brain lesions vs. those on interferon beta-1a

-- Currently there are no specifically approved disease modifying therapies

for children and adolescents with MS, a population at high risk of

long-term disability

-- MS is a highly debilitating disease which touches every aspect of young

patients' daily lives, from school performance to family relations and

friendships

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

https://novartis.gcs-web.com/Novartis-PARADIGMS-data-show-children-and-adolescents-with-MS-had-an-82-percent-lower-relapse-rate-with-Gilenya-vs-interferon-beta-1a

Basel, October 28, 2017 - Novartis today announced full results from the

positive Phase III PARADIGMS study, investigating the safety and

efficacy of Gilenya(R) (fingolimod) vs. interferon beta-1a, in children

and adolescents (ages 10 to 17) with multiple sclerosis (MS). Treatment

with oral Gilenya resulted in an 82% reduction in the rate of relapses

(annualized relapse rate) over a period of up to two years, compared to

interferon beta-1a intramuscular injections (p <0.001)[1]. PARADIGMS is

the first ever controlled, randomized trial specifically designed for

pediatric MS. The results have been presented at the 7(th) Joint

European and Americas Committee for Treatment and Research in Multiple

Sclerosis (ECTRIMS-ACTRIMS) meeting on October 28, 2017 in Paris,

France.

"Pediatric MS patients experience more frequent relapses and are more

likely to accumulate physical disability at an earlier age than patients

diagnosed as adults," said Dr. Tanuja Chitnis, Principle Investigator

for PARADIGMS and Director of the Partners Pediatric Multiple Sclerosis

Center, Massachusetts General Hospital, Boston, US, and Scientist, Ann

Romney Center, Brigham and Women's Hospital, Boston, US. "Yet, current

therapies are limited to drugs that have not been tested in a controlled

manner in this age group. PARADIGMS was uniquely designed for this

patient population. Its results signify an important step towards a

potential new treatment that could improve the lives of these young

patients."

Additional data from the study demonstrated:

-- A significant reduction in the number of new / newly enlarging T2 and

Gd-T1 lesions in the brain of Gilenya treated patients compared to those

treated with interferon beta-1a, as measured by magnetic resonance

imaging (MRI)[1]. The number and volume of lesions are associated with

increased relapses and disability progression[2].

-- Individuals treated with Gilenya had significantly less brain shrinkage

(measured by MRI as brain volume loss), compared to those treated with

interferon beta-1a[1]. Brain shrinkage in adults is associated with the

loss of physical and cognitive functionSHY[3].

-- The safety profile of Gilenya was overall consistent with that seen in

previous clinical trials, with more adverse events reported in the

interferon group[1].

-- In an additional analysis, Gilenya significantly delayed disability

progression, defined as Confirmed Disability Progression (CDP), compared

to interferon beta-1a[1].

"There is already substantial evidence that Gilenya is an effective

treatment that improves long-term outcomes for adults with relapsing MS.

We are delighted that PARADIGMS has shown such meaningful benefits for

children and adolescents with MS," said Vas Narasimhan, Global Head of

Drug Development and Chief Medical Officer, Novartis. "This pioneering

study demonstrates our continued commitment to providing new treatment

options to MS patients with the highest need. We look forward to working

with health authorities and preparing for submission."

Gilenya is not currently approved for the treatment of pediatric MS.

Novartis is working on submission with health authorities worldwide.

About the Phase III PARADIGMS study

The Phase III PARADIGMS study (NCT01892722) is a flexible duration (up

to two years), double-blind, randomized, multi-center study to evaluate

the safety and efficacy of oral Gilenya compared to interferon beta-1a

in children and adolescents with a confirmed diagnosis of multiple

sclerosis (MS), followed by a five-year open label extension phase[4].

The study enrolled 215 children and adolescents with MS, between the

ages of 10 and 17 years with an Expanded Disability Status Scale (EDSS)

score between 0 and 5.5[4]. Patients were randomized to receive

once-daily oral Gilenya (0.5 mg or 0.25 mg, dependent on patients' body

weight) or intramuscular interferon beta-1a once weekly[4].

The primary endpoint of the study was the frequency of relapses in

patients treated up to 24 months (annualized relapse rate)[4]. Secondary

endpoints include the number of new or newly enlarged T2 lesions,

Gadolinium enhancing T1 lesions, safety and the pharmacokinetic

properties of Gilenya, all measured throughout the treatment period[4].

The Phase III PARADIGMS study was conducted in 87 sites over 25

countries, and was designed in partnership with the US Food and Drug

Administration, the European Medicines Agency and the International

Pediatric Multiple Sclerosis Study Group.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic disorder of the central nervous

system (CNS) that disrupts the normal functioning of the brain, optic

nerves and spinal cord through inflammation and tissue loss[5]. In

adults, there are three types of MS: relapsing-remitting MS (RRMS),

secondary progressive MS (SPMS) and primary progressive MS (PPMS)[6]. In

children, RRMS accounts for nearly all cases (approximately 98

percent)[7].

The evolution of MS results in an increasing loss of both physical and

cognitive (e.g. memory) function. This has a substantial negative impact

on the lives of the approximately 2.3 million people worldwide affected

by MS, of which between three and five percent are estimated to be

children[8],[9].

About Gilenya (fingolimod) in adults

Gilenya (fingolimod) is an oral disease-modifying therapy (DMT) that is

highly efficacious at controlling disease activity in relapsing multiple

sclerosis (RMS)[10]. Gilenya has a reversible lymphocyte redistribution

effect targeting both focal and diffuse central nervous system (CNS)

damage caused by MS[11],[12]. Long-term clinical trial and real-world

evidence and experience has shown Gilenya treatment to be convenient for

individuals to incorporate into everyday life, leading to high treatment

satisfaction, long-term persistence, and ultimately, improved long-term

outcomes for people with RMS[13],[14].

Gilenya impacts four key measures of RMS disease activity: relapses, MRI

lesions, brain shrinkage (brain volume loss) and disability

progression[15],[16]. Its effectiveness on all of these measures has

been consistently shown in multiple controlled clinical studies and in

the real-world setting. Studies have shown its safety and high efficacy

to be sustained over the long term, demonstrating that switching to

Gilenya treatment as early in the disease course as possible can be

beneficial in helping to preserve individuals' function[17],[18].

Gilenya is approved in the US for the first-line treatment of relapsing

forms of MS in adults, and in the EU for adult patients with

highly-active relapsing-remitting MS (RRMS) defined as either high

disease activity despite treatment with at least one DMT, or

rapidly-evolving severe RRMS[10],[19].

Gilenya has been used to treat more than 217,000 patients in both

clinical trials and the post-marketing setting, with approximately

480,000 years of patient experience[20].

About Novartis in Multiple Sclerosis

Alongside Gilenya (fingolimod, an S1P modulator), Novartis' multiple

sclerosis (MS) portfolio includes Extavia(R) (interferon beta-1b for

subcutaneous injection) which is approved in the US for the treatment of

relapsing forms of MS. In Europe, Extavia is approved to treat people

with relapsing-remitting MS, secondary progressive MS (SPMS) with active

disease and people who have had a single clinical event suggestive of

MS.

Investigational compounds include BAF312 (siponimod), under

investigation in MS, and OMB157 (ofatumumab), a fully human monoclonal

antibody under investigation in relapsing MS. OMB157 targets CD20, and

is currently being investigated in two Phase III pivotal studies.

In the US, the Sandoz Division of Novartis markets Glatopa(R)

(glatiramer acetate injection) 20mg/mL, the first generic version of

Teva's Copaxone(R) * 20mg.

*Copaxone(R) is a registered trademark of Teva Pharmaceutical Industries

Ltd.

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," "exciting," "underway," "upcoming," or similar terms, or by

express or implied discussions regarding potential marketing approvals,

new indications or labeling for the investigational and 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

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October 28, 2017 02:55 ET (06:55 GMT)