Press Release: New data at AAN reinforce Novartis commitment to transforming the lives of people of all ages who live with neurological conditions

Novartis International AG / New data at AAN reinforce Novartis

commitment to transforming the lives of people of all ages who live with

neurological conditions. Processed and transmitted by West Corporation.

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

-- Novartis leads the way at AAN with 53 abstracts, showcasing its broad

portfolio of transformative medicines and innovative solutions for people

living with spinal muscular atrophy (SMA), multiple sclerosis (MS) and

migraine

-- Interim data from multiple ongoing clinical studies of

Zolgensma(R)*(onasemnogene abeparvovec-xioi; AVXS-101) show positive

results in the treatment of SMA[1]-[12]

-- EXPAND analyses show people with secondary progressive MS (SPMS) taking

Mayzent(R) (siponimod) - the only therapy proven to delay disability

progression in a study of typical SPMS patients - experienced significant

benefits on cognitive function[13]

-- With the greatest real world exposure and longest clinical trial

experience of any anti-CGRP therapy, Aimovig(R) (erenumab) continues to

show positive long-term safety and efficacy across the spectrum of

migraine with new clinical trial data[14]-[22]

Basel, April 30, 2019 - Novartis announced today it will present 53

abstracts from across its unique neurological portfolio and pipeline at

the upcoming 71(st) American Academy of Neurology (AAN) meeting May 4 -

10 in Philadelphia, Pennsylvania, USA. The breadth and depth of the data

highlights the company's commitment to decoding the science behind

neurological diseases such as spinal muscular atrophy (SMA), multiple

sclerosis (MS) and migraine.

"Our presence at AAN this year is a testament to how we are reimagining

medicine across a broad spectrum of neurological diseases, for many

patients of all ages," said Danny Bar-Zohar, Global Head, Neuroscience

Development for Novartis Pharmaceuticals. "Nothing is more rewarding

than combining cutting-edge science, advanced algorithms and technology

with a relentless ambition to bring life-changing solutions to people

who need them."

Novartis highlights at AAN include:

Spinal muscular atrophy[1]-[12]:

-- Four new scientific abstracts spanning the clinical development program

for the investigational gene therapy Zolgensma(R) (onasemnogene

abeparvovec-xioi; AVXS-101) show positive results in the treatment of

SMA.

-- Interim data presented for the first time from the Phase I STRONG trial

demonstrated encouraging results via the intrathecal delivery in patients

with SMA Type 2.

-- New interim data from the Phase III STR1VE study demonstrated survival

and motor function improvements that continue to parallel the Phase I

START study.

-- Preliminary data from the Phase III SPR1NT trial demonstrated significant

motor function improvements in pre-symptomatic SMA patients.

-- Data from the ongoing long-term follow-up study for the Phase I START

trial show no waning of motor milestone achievements in patients with SMA

Type 1.

-- Three health economics studies demonstrated improved survival and

milestone achievement with Zolgensma.

-- New data supporting the potential use of serum neurofilament light chain

as biomarker for SMA Type 1 disease activity and therapy response under

branaplam (LMI070), an oral, once-weekly RNA splicing modulator.

Zolgensma was granted Priority Review for the treatment of SMA Type 1 by

the FDA and regulatory action is anticipated in May 2019.

Multiple Sclerosis[12],[13](,) [23]-[38]:

-- New analyses from the Phase III EXPAND study show Mayzent(R) (siponimod)

had a sustained benefit on cognition in secondary progressive MS (SPMS)

patients. Impaired cognitive function is a key aspect of disability

associated with MS. It substantially affects the social and professional

lives of people with MS and their families. Mayzent was approved by US

Food and Drug Administration (FDA) in March 2019 for the treatment of

adults across the spectrum of relapsing multiple sclerosis, including

SPMS with active disease*. It is the only FDA-approved treatment for

active SPMS, based on a positive pivotal study in a typical SPMS

population.

-- Presented for the first time, the full results from the Phase III ASSESS

study, a direct head-to-head trial comparing Gilenya(R) (fingolimod) vs.

glatiramer acetate patients with RRMS. Top line results announced in

October 2018 showed treatment with Gilenya 0.5mg demonstrated superior

efficacy in significant reduction of annualized relapse rate, with nearly

41% fewer relapses versus glatiramer acetate, as well beneficial effects

on other key measures of disease activity.

-- MSProDiscussTM, the first-of-its-kind algorithm-based tool developed

side-by-side with renowned MS researchers, healthcare professionals and

patients, to facilitate doctor-patient discussions around MS progression.

-- Scientific explorations of ofatumumab, the first fully human anti-CD20

monoclonal antibody with a monthly self-administered subcutaneous dosing

regimen tailored for RMS, allowing for the potential preservation of

immune function.

-- Furthermore, new analyses supporting neurofilaments as an increasingly

used biomarker in MS clinical trials will be highlighted. Utilizing blood

neurofilaments as an easy-to-use biomarker for MS could revolutionize the

way MS treatments are assessed in clinical trials and ultimately, in

clinical practice. Novartis is leading the field with 18 data analyses

presented so far.

*Mayzent was approved by the US FDA in March 2019 for the treatment of

adults with relapsing forms of multiple sclerosis, including SPMS with

active disease, relapsing remitting multiple sclerosis (RRMS) and

clinically isolated syndrome (CIS). 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.

Migraine[14]-[22]:

-- Nine new scientific abstracts on Aimovig(R) (erenumab), reinforcing the

extensive long term safety and efficacy profile of the drug across the

spectrum of migraine, including chronic, episodic and difficult to treat

migraine patients.

-- A new set of data shows that a majority of chronic migraine patients on

Aimovig converted to episodic migraine. In a separate study, almost two

thirds of patients with episodic migraine reported a sustained reduction

of migraine days at one year.

Aimovig has been studied extensively in a broad clinical program

involving more than 3,000 patients. Since launch in May 2018, Aimovig

has been used to treat an estimated 220,000 patients worldwide, making

it the most prescribed anti-CGRP therapy worldwide.

Novartis in Neuroscience

Novartis has a strong ongoing commitment to neuroscience and to bringing

innovative treatments to patients suffering from neurological conditions

where there is a high unmet need. We are committed to supporting

patients and physicians in multiple disease areas, including MS,

migraine, Alzheimer's disease and Parkinson's disease and have a

promising pipeline in MS, Alzheimer's disease and spinal muscular

atrophy.

About AveXis, a Novartis Company

AveXis, a Novartis company, is dedicated to developing and

commercializing novel treatments for patients suffering from rare and

life-threatening neurological genetic diseases. Our initial product

candidate, Zolgensma (onasemnogene abeparvovec-xioi; AVXS-101), is its

proprietary gene therapy currently in development for the treatment of

spinal muscular atrophy, or SMA. In addition to developing Zolgensma to

treat SMA, AveXis also plans to develop other novel treatments for rare

neurological diseases, including Rett syndrome and a genetic form of

amyotrophic lateral sclerosis caused by mutations in the superoxide

dismutase 1 (SOD1) gene. For additional information, please visit

www.avexis.com.

About Amgen and Novartis Neuroscience Collaboration

In August 2015, Amgen entered into a global collaboration with Novartis

to develop and commercialize pioneering treatments in the field of

migraine and Alzheimer's disease. The collaboration focuses on

investigational Amgen drugs in the migraine field, including Aimovig

(approved by the FDA in May 2018 for the preventive treatment of

migraine in adults). In April 2017, the collaboration was expanded to

include co-commercialization of Aimovig in the U.S. For the migraine

programs, Amgen retains exclusive commercialization rights in the U.S.

(other than for Aimovig as described above) and Japan, and Novartis has

exclusive commercialization rights in Europe, Canada and rest of world.

Also, the companies are collaborating in the development and

commercialization of a beta-secretase 1 (BACE) inhibitor program in

Alzheimer's disease. The oral therapy CNP520 (currently in Phase III for

Alzheimer's disease) is the lead molecule and further compounds from

both companies' pre-clinical BACE inhibitor programs may be considered

as follow-on molecules. At the center of the Amgen and Novartis

neuroscience collaboration is the shared mission to fight migraine and

the stereotypes and misperceptions surrounding this debilitating

disease.

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

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April 30, 2019 16:30 ET (20:30 GMT)