Press Release: Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig(R) (erenumab) in patients with chronic and epi...

Novartis International AG / Novartis presents new data demonstrating

long-term efficacy, safety and tolerability of Aimovig(R) (erenumab) in

patients with chronic and episodic migraine. Processed and transmitted

by Nasdaq Corporate Solutions. The issuer is solely responsible for the

content of this announcement.

-- Results from a one-year study of efficacy and safety of Aimovig in

chronic migraine and data from a three-year analysis assessing safety and

tolerability of Aimovig in episodic migraine will be presented at AHS

-- Aimovig showed robust efficacy in patients with chronic migraine, with

substantial reductions in monthly migraine days sustained throughout the

study

-- Safety data in both studies were consistent with the placebo-like safety

profile seen for Aimovig across the clinical trial program of 3,000

patients

-- Aimovig is the first and only FDA-approved treatment designed

specifically to prevent migraine; EMA approval is expected in the coming

months

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

https://novartis.gcs-web.com/Novartis-presents-new-data-demonstrating-long-term-efficacy-safety-and-tolerability-o-Aimovig-erenumab-in-patients-with-chronic-and-episodic-migraine%20

Basel, June 28, 2018 - Novartis today announced the results of two

open-label extension studies (OLE) of Aimovig(R) (erenumab) in patients

with chronic and episodic migraine, which will be presented at the

60(th) Annual Scientific Meeting of the American Headache Society in San

Francisco[1],[2]. The data reinforce the established safety and efficacy

profile of Aimovig in long-term use for patients with chronic migraine.

In addition, data will be presented from the longest running study of a

CGRP therapy, demonstrating the long-term safety and tolerability of

Aimovig in episodic migraine. Aimovig is the first and only FDA-approved

treatment specifically developed to prevent migraine by blocking the

calcitonin gene-related peptide receptor (CGRP-R), which is believed to

play a critical role in migraine.

In the study in chronic migraine patients (15 or more migraine days per

month), the primary and secondary endpoints were long-term safety and

efficacy, respectively[1]. The safety results after one year were

consistent with the established safety profile of Aimovig in previous

studies. The most frequent adverse events (AEs) were viral upper

respiratory tract infection, upper respiratory tract infection,

sinusitis, arthralgia, and migraine.

The efficacy data showed sustained benefits up to one year. Compared to

a baseline of 18.1 average monthly migraine days, patients taking

Aimovig 140mg and 70mg (based on last dose received) respectively

achieved a:

-- Substantial reduction of average monthly migraine days - 10.5 and 8.5

days

-- 50% or more reduction in monthly migraine days - 67% and 53%

-- 75% or more reduction in monthly migraine days - 42% and 27%

-- Migraine-free status (100% reduction) - 13% and 6%

"These data showing sustained efficacy and consistent safety and

tolerability of Aimovig over an extended period of time are important

for migraine patients and their clinicians to know," said Stewart J.

Tepper, M.D., professor of neurology at the Geisel School of Medicine at

Dartmouth Medical School. "Collectively these data reinforce the safety

and tolerability of Aimovig, and having a treatment specifically

designed for migraine has the potential to truly improve the lives of

those living with this neurological disease."

The results from a three-year interim data analysis of the five-year OLE

study assessing safety in episodic migraine (four or more migraine days

per month) showed Aimovig had a safety profile consistent with the

spectrum and rate of AEs seen in shorter-term placebo-controlled

studies. The most frequent AEs were viral upper respiratory tract

infection, upper respiratory tract infection, sinusitis, influenza, and

back pain and there were no new safety signals.

"Following FDA approval, with European approval anticipated in the

coming months, we are very pleased to report positive long-term safety

and efficacy results for Aimovig," said Danny Bar-Zohar, Global Head of

Neuroscience Development at Novartis Pharmaceuticals. "For patients who

have suffered from migraine for years, these new data further confirm

that Aimovig may offer long-term sustained and safe relief from migraine

and the heavy burden it imposes."

Aimovig was approved by the FDA on May 17, 2018. The Committee for

Medicinal Products for Human Use (CHMP) of the European Medicines Agency

(EMA) delivered a positive opinion for Aimovig for the prevention of

migraine in adults on May 31, 2018. The European Commission will review

the CHMP opinion before delivering its final decision.

Novartis and Amgen are co-commercializing Aimovig in the U.S, Amgen has

exclusive commercialization rights to the drug in Japan and Novartis has

exclusive rights to commercialize in the rest of the world.

About the Open-Label Extension Study in Chronic Migraine

After the 12-week, Phase II, double-blind placebo-controlled parent

study, eligible patients could enroll in the OLE. 451 people completed

the study receiving either Aimovig 70 mg, 140 mg or changing from 70 mg

to 140 mg during the course of the study. Of the 609 patients who

enrolled in the study, 199 increased their dose from 70 mg to 140 mg by

week 28[1].

The primary outcome measure of the study was long-term safety. The

secondary outcome measure was efficacy, as determined by four measures:

change from baseline to week 52 in monthly migraine days (MMD), monthly

acute migraine-specific medication days, monthly cumulative hours of

headache, and proportion of patients achieving at least a 50% reduction

in MMD.

The most frequent adverse events (greater than 2.0 per

100-subject-years) were viral upper respiratory tract infection, upper

respiratory tract infection, sinusitis, arthralgia, and migraine. In the

double-blind treatment phase, no differences were observed in the safety

events between Aimovig and placebo.

About the Open-Label Extension Study in Episodic Migraine

Following a Phase II 12-week double-blind, placebo-controlled study of

Aimovig in adults with episodic migraine, patients could enroll in the

OLE, initially receiving 70 mg Aimovig monthly. A protocol amendment

increased the dosage to 140 mg monthly to assess long-term safety of the

higher dose. Safety and tolerability were assessed by monitoring AEs,

electrocardiograms, laboratory assessments, and vital signs. Of the 383

patients who enrolled in the open-label extension, 235 patients (61.3

percent) remained in the OLE study at the data cutoff point for this

interim analysis, all having received Aimovig for at least three years.

The study is continuing for up to five years of treatment.

Data at approximately four and five years of treatment will be reported

in the future.

About Aimovig(R) (erenumab)

Aimovig is the only FDA-approved treatment specifically developed to

prevent migraine by blocking the calcitonin gene related peptide

receptor (CGRP-R), which plays an important role in migraine. Aimovig

has been studied in several large, global, randomized, double-blind,

placebo-controlled studies to assess its safety and efficacy in migraine

prevention. More than 3,000 patients have participated in our overall/

clinical trial program across the four placebo-controlled Phase II and

Phase III clinical studies, their open-label extensions and further

studies such as LIBERTY, a dedicated study in a difficult-to-treat

treatment failure population.

About Migraine

Migraine is a distinct neurological disease[3]. It involves recurrent

attacks of moderate to severe head pain that is typically pulsating,

often unilateral and associated with nausea, vomiting and sensitivity to

light, sound and odors[4]. Migraine is associated with personal pain,

disability and reduced quality of life, and financial cost to

society[5]. It has a profound and limiting impact on an individual's

abilities to carry out everyday tasks and was reported by the World

Health Organization to be one of the top 10 causes of years lived with

disability for men and women[6]. It remains under-recognized and

under-treated[5],[7]. Existing preventive therapies have been repurposed

from other indications and are often associated with poor tolerability

and lack of efficacy, with high discontinuation rates among patients[8].

About Novartis and Amgen Neuroscience Collaboration

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

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) and AMG 301 (currently in Phase II development). In

April 2017, the collaboration was expanded to include

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

Amgen retains exclusive commercialization rights in 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.

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

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June 28, 2018 16:30 ET (20:30 GMT)