Press Release: Novartis marks a new era for migraine patients with the EU approval of Aimovig(R), a first-of-its-kind treatment specifically designed for mig...

Novartis International AG / Novartis marks a new era for migraine

patients with the EU approval of Aimovig(R), a first-of-its-kind

treatment specifically designed for migraine prevention. Processed and

transmitted by Nasdaq Corporate Solutions. The issuer is solely

responsible for the content of this announcement.

-- Patients on Aimovig (erenumab) in clinical trials reported consistent and

sustained migraine prevention, with many experiencing a 50% or more

reduction in monthly migraine days; safety and tolerability were similar

to placebo[1]-[3]

-- Migraine is the third leading cause of disability in people under 50,

leading to severe disruption to the personal and professional lives of

millions of sufferers; it is estimated to cost up to EUR27 billion per

year in Europe alone[4],[5]

-- Aimovig is the first and only approved migraine prevention treatment

designed specifically to block the calcitonin gene-related peptide

receptor (CGRP-R), which plays a critical role in migraine

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

https://novartis.gcs-web.com/Novartis-mark-a-new-era-for-migraine-patients-with-the-EU-approval-of-Aimovig-a-first-of-its-kind-treatment-specifically-designed-for-migraine-prevention

Basel, July 30, 2018 - Novartis announced today that the European

Commission (EC) approved Aimovig(R) (erenumab) for the prevention of

migraine in adults experiencing four or more migraine days per month.

Aimovig is the first and only treatment specifically designed for

migraine prevention to be approved in the European Union, Switzerland,

the US and Australia. It works by blocking a receptor called the

calcitonin gene-related peptide receptor (CGRP-R) which plays a critical

role in mediating the incapacitating pain of migraine. In the extensive

clinical program of 2,600 patients, those on Aimovig experienced

significant reductions in their number of migraine days per month, with

a safety and tolerability profile similar to placebo[1]-[3]. Aimovig can

be self-administered or administered by another trained person every

four weeks with the SureClick(R) autoinjector pen, an established device

commonly used for a range of different conditions.

"Migraine matters. It is a painful, highly disruptive neurological

disease that affects all aspects of life, from going to work to spending

time with family and friends," said Patrick Little, President of the

European Migraine and Headache Alliance. "A treatment specifically

designed for migraine prevention is a much-welcomed innovation and could

transform lives of patients for whom current therapies do not work or

are not well tolerated."

Aimovig showed efficacy even in a difficult-to-treat population. It is

the only CGRP-R pathway therapy specifically studied in patients who had

failed on two to four previous treatments commonly used for migraine

prevention[6]. Furthermore, in an interim analysis from a five year open

label extension (OLE) in episodic migraine, it was demonstrated that

more than one in four (26%), patients taking Aimovig 70 mg, who were

still enrolled and assessed for migraine over month fifteen, were

completely migraine free[7].

"Erenumab heralds a new era in clinical practice, bringing both a

targeted mechanism for prevention and a deep understanding of migraine,

which we have never had before," said Peter Goadsby, M.D., Ph.D., FRCP,

Director, NIHR-Wellcome Trust King's Clinical Research Facility and

Professor of Neurology at King's College London. "We will see sustained

relief from migraine for many of those who suffer with this debilitating

disease."

"Today's approval is groundbreaking for people living with migraine,

their families and doctors" said Paul Hudson, CEO Novartis

Pharmaceuticals. "In clinical trials, Aimovig has consistently shown to

be effective in preventing migraine and bringing relief from the grip of

this disease. We are proud to be the first to reimagine migraine

prevention and we are committed to ensuring Aimovig's availability for

those who could benefit from it. We are launching a tailored

post-approval access program and are exploring a number of innovative

reimbursement and access approaches, including paying only for patients

who respond well to treatment."

A post-approval access program has been opened to provide Aimovig in

countries where the local regulations allow provision of unapproved or

yet to be reimbursed therapies. Support programs are also being

developed for eligible patients in line with local regulations that

include personalized services, information and resources to support them

as they begin their treatment with Aimovig.

The EMA decision is applicable to all 28 European Union member states

plus Iceland, Norway and Liechtenstein. Aimovig (erenumab-aooe) received

U.S. FDA approval for the preventive treatment of migraine in adults on

May 17, 2018. Aimovig received Swissmedic approval in Switzerland on

July 13, 2018 and Australian TGA registration on July 3, 2018.

Additional regulatory filings are underway with other health authorities

worldwide.

About Aimovig(R) (erenumab)

Aimovig is the only EMA, Swissmedic, Australian TGA and FDA-approved

migraine prevention treatment designed specifically to block the

calcitonin gene related peptide receptor (CGRP-R), which plays a

critical 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. This includes

2,600 participants across the four placebo-controlled pivotal Phase II

and Phase III clinical studies as well as participants in further

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

treatment failure population. The most common side effects in the

clinical program to date have been viral upper respiratory tract

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

back pain.

Novartis and Amgen are co-commercializing Aimovig in the US. Amgen has

exclusive commercialization rights to the drug in Japan and Novartis has

exclusive rights to commercialize in the rest of the world.

About Migraine

Migraine is a distinct neurological disease[8]. 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[9]. Migraine is associated with personal pain,

disability and reduced quality of life, and financial cost to

society[10]. 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[4]. It remains under-recognized and

under-treated[10],[11]. 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[12].

We "Get" Migraine - About Novartis' Commitment to People Living with

Migraine

Through support and education, we aim to challenge public perception of

migraine, assist people in getting appropriate treatment and facilitate

informed communication among people with migraine and with those who

live and work with them, including co-workers and employers.

As an employer, Novartis is also committed to supporting its associates

living with migraine. The Migraine Care program is a pilot program

created by Novartis, in collaboration with patient groups and leading

experts in neurology, telemedicine and digital, to provide a

complimentary service for all Swiss based Novartis associates living

with migraine to improve their quality of life. The program aims to

raise awareness of migraine in the workplace and provide free coaching

to Novartis associates living with migraine to empower them in the

management of the disease. Novartis is exploring opportunities to work

with other employers who are interested in supporting their employees

and family members living with migraine.

Novartis is also committed to working with the migraine community around

the world to discover new ways to improve care for people living with

the disease. Novartis and the European Migraine and Headache Alliance

collaborated to launch the My Migraine Voice survey, a global survey

designed to assess the worldwide migraine burden from the patient's

perspective[13]. Data was collected from 11, 266 adults via a 30-minute

online questionnaire fielded in 31 countries between September 2017 and

February 2018. The survey questions covered the social, economic and

emotional impact of the disease, the real-life experience of an

individual living with migraine and their journey through the healthcare

system and employment environment[13].

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

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July 30, 2018 16:30 ET (20:30 GMT)