Press Release: Novartis presents first-of-its-kind evidence at AAN reinforcing robust and consistent efficacy of AimovigTM* (erenumab) for migraine patients ...

Novartis International AG / Novartis presents first-of-its-kind evidence

at AAN reinforcing robust and consistent efficacy of AimovigTM*

(erenumab) for migraine patients with multiple treatment failures.

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solely responsible for the content of this announcement.

-- The LIBERTY trial studied patients with episodic migraine who had failed

2 to 4 prior treatments, a uniquely difficult-to-treat population often

excluded from migraine prevention trials

-- Patients taking erenumab had nearly three-fold higher odds of having

their migraine days cut by half or more compared to placebo

-- Study completion, safety and tolerability were consistent with results

seen in the pivotal clinical program - over 97% of those taking erenumab

completed the double-blind treatment phase and erenumab showed a

placebo-like safety and tolerability profile

-- Data selected by the American Academy of Neurology Science Committee as

one of the most noteworthy presentations at this year's annual meeting

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

https://novartis.gcs-web.com/Novartis-presents-first-of-its-kind-evidence-at-AAN-reinforcing-robust-and-consistent-efficacy-of-AimovigTM-erenumab-for-migraine-patients-with-multiple-treatment-failures

Basel, April 17, 2018 - Novartis today announced full results from the

Phase IIIb LIBERTY trial of Aimovig (erenumab, AMG 334) in episodic

migraine patients who had previously failed two to four preventive

treatments, due to lack of efficacy or intolerable side effects[1]. The

data, which will be presented at the annual meeting of the American

Academy of Neurology (AAN) in Los Angeles, show the potential of

investigational erenumab as an effective preventive treatment option for

these patients, who have tried several treatment options without gaining

relief. Erenumab is the only fully human monoclonal antibody under

regulatory review that was designed to selectively block the calcitonin

gene-related peptide (CGRP) receptor, which plays a critical role in

migraine activation. LIBERTY is the first study to investigate a

treatment targeting the CGRP pathway specifically in this challenging

patient population.

In LIBERTY, 246 patients who had experienced two to four previous

preventive treatment failures were randomized to receive monthly

subcutaneous injections of either erenumab 140mg or placebo for 12

weeks. Patients taking erenumab had nearly three-fold higher odds of

having their migraine days cut by at least 50%, with more than twice as

many patients taking erenumab achieving this reduction compared to

placebo (weeks 9-12: 30.3% with erenumab, 13.7% with placebo, p=0.002,

odds ratio 2.73).

"The LIBERTY study distinctively demonstrates the ability of an

anti-CGRP receptor antibody to significantly reduce migraine frequency

and its associated burden in patients who could not find the relief they

need with the currently available preventive treatment options," said

Prof. Uwe Reuter, Managing Medical Director at Charité

Universitätsmedizin. "These compelling data offer new hope of fewer

migraine days to those people with migraine who may have cycled through

current standard of care unsuccessfully for years due to lack of

efficacy and tolerability."

In the study, patients taking erenumab also had statistically

significant and clinically meaningful improvements from baseline

compared to placebo across all secondary endpoints:

-- Reduction in monthly migraine days

-- Decrease in acute migraine-specific drug use

-- 75% or greater reduction in monthly migraine days

-- 100% reduction in monthly migraine days

-- Improved physical functioning and ability to complete everyday activities

as measured by the Migraine Physical Function Impact Diary (MPFID) scales

Over 97% of erenumab patients completed the double-blind phase of the

LIBERTY study. There were no adverse events leading to discontinuation

of treatment in the erenumab group while 0.8% of those in the placebo

group experienced adverse events leading to discontinuation of

treatment.

"In LIBERTY, all primary and secondary endpoints were met. These data,

combined with the previously reported positive results, further

reinforce erenumab's robust efficacy and safety profile seen across the

full spectrum of migraine," said Danny Bar-Zohar, Global Head of

Neuroscience Development at Novartis. "We strive to demonstrate that our

novel therapies provide high value to those patients who continue to

suffer, despite standard of care and so we are excited to bring this

targeted prevention option, and hope, to these patients as soon as we

can."

LIBERTY contributes to an extensive body of evidence, across the

spectrum of migraine, in support of the sustained efficacy, safety and

tolerability profile of erenumab including four placebo-controlled Phase

II and Phase III clinical studies involving more than 3,000 patients, as

well as ongoing open-label extension trials up to five years in

duration. If approved, erenumab will be administered every four weeks

using a self-injection device. Subject to approval, Novartis and Amgen

will co-commercialize erenumab 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.

*The brand name Aimovig(TM) has been provisionally approved by the FDA

and EMA for the investigational product erenumab (AMG 334), but the

product itself has not been approved for sale in any country.

About LIBERTY

LIBERTY (NCT03096834) is a Phase IIIb, multicenter, randomized 12-week,

double-blind, placebo-controlled study evaluating the safety and

efficacy of erenumab in patients with episodic migraine (defined in the

trial as four to 14 migraine days per month at baseline) who have failed

two to four prior preventive treatments for migraine. In the study, 246

participants were randomized to receive erenumab140mg or placebo during

the 12-week double-blind treatment phase. The primary endpoint was the

percentage of patients with at least 50% reduction of monthly migraine

days from baseline over the last four weeks of the double-blind

treatment phase of the study (weeks 9-12)[2]. The trial includes an

ongoing 52 week open-label extension study.

Secondary endpoints assessed during the same time period included:

change from baseline in monthly migraine days, change from baseline in

the number of monthly acute migraine-specific medication treatment days,

change from baseline in the Migraine Physical Function Impact Diary

(MPFID) physical impairment and impact on everyday activities domain

scores. The MPFID is a scale developed to measure these two domains. It

has been validated in line with US Food and Drug Administration Patient

Reported Outcomes Guidance[3]. Percentages of patients with a 75%

response rate and 100% response rate to erenumab, and safety and

tolerability were also assessed as secondary endpoints.

About Aimovig (erenumab)

Aimovig (erenumab, AMG 334) is the only investigational treatment under

regulatory review that was specifically designed to prevent migraine by

blocking the CGRP receptor, which plays an important role in migraine

activation. 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 clinical trial program including the four

placebo-controlled Phase II and Phase III clinical studies and their

open-label extensions. The brand name Aimovig(TM) has been provisionally

approved by the FDA and EMA for the investigational product erenumab

(AMG 334), but the product itself has not been approved for sale in any

country.

About Migraine

Migraine is a distinct neurological disease[4]. 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[5]. Migraine is associated with personal pain,

disability and reduced quality of life, and financial cost to

society[6]. It has a profound and limiting impact on an individual's

abilities to carry out everyday tasks, and was declared by the World

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

disability for men and women[7]. It remains under-recognized and

under-treated[6],[8]. 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[9].

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 erenumab

(Biologics License Application submitted to FDA in May 2017) and AMG 301

(currently in Phase II development). In April 2017, the collaboration

was expanded to include co-commercialization of erenumab in the U.S. For

the migraine programs, Amgen retains exclusive commercialization rights

in the U.S. (other than for erenumab 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.

Disclaimer

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April 17, 2018 16:00 ET (20:00 GMT)