Allergan's Study in Chronic Migraine Receives Migraine Research Award at the American Headache Society's 60th Annual Scientific Meeting

DUBLIN, June 28, 2018 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, announced today that the Company's sponsored CaMEO (Chronic Migraine Epidemiology and Outcomes) study is being recognized with the 2018 Harold G. Wolff Lecture Award for its continued commitment to understanding the natural disease course of migraine with the acceptance of the manuscript, "Identifying Natural Subgroups of Migraine Based on Comorbidity and Concomitant Condition Profiles: Results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study" to Headache. The American Headache Society awards the Harold G. Wolff Lecture Award to the best manuscript on headache, head or face pain, or the nature of pain itself. Allergan has been a leader in Chronic Migraine research for over 20 years and sponsored CaMEO to support the clinical community by generating data to characterize natural disease course, quantify individual, economic, societal and familial impact of life with migraine, specifically Chronic Migraine, and to provide evidence-based foundation to improve Chronic Migraine management. 

"As a leader in migraine treatment, Allergan is committed to understanding the condition's impact on patients and evaluating both current and pipeline therapies to optimize treatment paradigms," said David Nicholson, Chief Research and Development Officer, Allergan. "Our data being presented at AHS underscores our continued goal of addressing the unmet needs of the migraine community."

This sub-analysis of CaMEO identified natural subgroups (clinically-meaningful groups of migraine patients) of those with migraine based on profiles of comorbidities and concomitant conditions. The identification of these subgroups may help inform the classification of migraine, predict prognosis, and identify people who respond to specific treatment classes, rather than using a trial and error approach.  As a result of the manuscript acceptance, a lecture on CaMEO will take place on Friday, June 29, 2018 at 2:15 pm PT.

"The CaMEO study helps us identify clinically meaningful subgroups of migraine, a first step towards developing a foundation for personalized medicine," said Dr. Richard B. Lipton, Professor and Vice Chair of Neurology, Professor of Epidemiology and Population Health and Director of the Montefiore Headache Center, all at the Albert Einstein College of Medicine. "It is a privilege to have CaMEO recognized at this year's American Headache Society. Furthermore, the data supports the opportunity for new advancements in migraine patient care and may lead to meaningful clinical trials."

In total, Allergan will present 18 abstracts.  Data from the ACHIEVE I and ACHIEVE II studies examining the efficacy, safety and tolerability of investigational oral CGRP ubrogepant were accepted as late breakers. Results from the FORWARD study comparing onabotulinumtoxinA and topiramate for headache prevention in adults with Chronic Migraine and long-term safety and efficacy data for onabotulinumtoxinA in the treatment of Chronic Migraine (COMPEL) will also be presented. Allergan will present five podium presentations and seven data blitz presentations.

The following have been accepted as podium presentations and are scheduled as follows (noted in local Pacific Time):

• Identifying Natural Subgroups of Migraine Based on Profiles of Comorbidities and Concomitant Conditions: Results of the Chronic Migraine Epidemiology and Outcomes Study. Authors: Lipton R, et al. Friday, June 29^th, 2:15-3:00 pm
• Life with Migraine, Effect on Relationships: Results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Buse D, et al. Friday, June 29^th, 12:20-12:30 pm
• Migraine Progression in Natural Subgroups of Migraine Based on Comorbidities and Concomitant Conditions: Results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Lipton R, et al. Saturday, June 30^th, 3:35-4:45 pm
• Ubrogepant for the Acute Treatment of Migraine: Efficacy, Safety, Tolerability, and Functional Impact Outcomes from a Single Attack Phase III Study, ACHIEVE I. Authors: Dodick D, et al. Saturday, June 30^th, 9:50-10:00 am
• A Multicenter, Prospective, Randomized, Open-Label Study to Compare OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults with Chronic Migraine: Patient Reported Outcomes From The FORWARD Study. Authors: Blumenfeld A, et al. Saturday June 30^th, 8:50-9:00 am

The scheduled poster presentations (noted in local Pacific Time) are as follows:

• Perceived Effect of Migraine on Career and Finances: Results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Manack Adams A, et al. Friday, June 29^th, 1:15-2:15 pm; Data Blitz Presentation 1:50-1:55 pm
• Patterns and Characterization of Acute Prescription Headache Medication Use: Results From the CaMEO Study. Authors: Lipton R, et al. Friday, June 29^th, 1:15-2:15 pm; Data Blitz Presentation 1:25-1:30 pm
• Self-Perceptions of What Life Would Be Like Without Migraine in Major Life Domains: Results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Lipton R, et al. Friday, June 29th, 1:15-2:15 pm; Data Blitz Presentation 1:50-1:55 pm
• Evaluating the Impact of Ubrogepant, an Acute Treatment for Migraine, on Patient-Reported Functionality and Satisfaction: Results from a Single Attack Phase III Study, ACHIEVE I. Authors: Dodick D, et al. Saturday, June 30^th, 1:00-2:15 pm; Data Blitz Presentation 1:35-1:40 pm
• Efficacy, Safety, and Tolerability of Ubrogepant for the Acute Treatment of Migraine: Results from a Single Attack Phase III Study, ACHIEVE II. Authors: Lipton R, et al. June 30^th, 1:00-2:15 pm; Data Blitz Presentation 1:30-1:35 pm
• A Multicenter, Prospective, Randomized, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine: The FORWARD Study. Authors: Rothrock J, et al. Friday, June 29^th, 1:15-2:15pm; Data Blitz Presentation 1:40-1:45pm
• Effect of OnabotulinumtoxinA Prevention on Comorbidities of Depression and Anxiety in Chronic Migraine: Analysis in Headache Day Frequency Responders vs Headache Day Frequency Non-Responders. Authors: Blumenfeld A, et al. Friday, June 29^th, 1:15-2:15pm
• The Long-Term Efficacy and Safety of OnabotulinumtoxinA for the Prevention of Chronic Migraine in Patients With Medication Overuse: Results of the COMPEL Study. Authors: Tepper S, et al. Friday, June 29^th, 1:15-2:15 pm
• Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Chronic Migraine Patients: COMPEL Analysis by Treatment Cycle. Authors: Blumenfeld A, et al. Friday, June 29^th, 1:15-2:15 pm
• Impact of OnabotulinumtoxinA on Quality of Life, Health Resource Utilization, and Work Productivity in People with Chronic Migraine: Interim Results from a Prospective, Observational Study (PREDICT). Authors: Boudreau G, et al. Friday, June 29^th, 1:15-2:15 pm
• Onset of Effect of OnabotulinumtoxinA for Chronic Migraine Treatment: Analysis of PREEMPT Data. Authors: Dodick D, et al. Friday, June 29^th, 1:15-2:15 pm
• Migraine Treatment Patterns and Opioid Use Among Chronic and Episodic Migraine Patients Identified by a Clinician-Administered Semi-Structured Diagnostic Interview. Authors: Yu JS, et al. Friday, June 29^th, 1:15-2:15 pm, Data Blitz Presentation 1:30-1:35 pm
• The Activity Impairment in Migraine – Diary (AIM-D): A Novel Migraine-specific Patient-reported Outcome Measure to Assess Functioning Based on Activity Impairment Related to Migraine in Episodic and Chronic Migraine Patients. Authors: Cala ML, et al. Friday, June 29^th, 1:15-2:15pm

About Migraine
Migraine is a chronic disease with episodic attacks defined by neurological symptoms such as headache pain, sensitivity to light, sound, and nausea that are often incapacitating.  It is highly prevalent, affecting approximately 1 in 7 individuals, and is associated with significant disability leading to societal and economic burden.  It may also prevent migraineurs from performing daily activities and significantly impacting their quality of life.  Despite its prevalence and the availability of treatments, migraine is an underdiagnosed and undertreated disease.  Substantial number of patients discontinue or cycle through treatments without adequately reducing migraine frequency or severity.  There is a need for novel, oral preventive treatments for migraine with improved benefit-risk profiles to fulfill this unmet need.

Allergan, a leader in the Chronic Migraine space, markets BOTOX^® (onabotulinumtoxinA), the first preventive treatment for adult Chronic Migraine patients since it was approved in 2010. Allergan is also advancing its migraine program with two investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists, which are being developed for the treatment and prevention of migraine. Allergan's CGRP receptor antagonists, ubrogepant in Phase 3 for the acute treatment of migraine and atogepant in Phase 2b for the prevention of migraine, are expected to be the first oral CGRP receptor antagonists to market.

BOTOX^® (onabotulinumtoxinA) Important Information

Indication

BOTOX^® is a prescription medicine that is injected to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older.

It is not known whether BOTOX^® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

IMPORTANT SAFETY INFORMATION

BOTOX^® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX^®:

Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.

Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX^® has been used at the recommended dose to treat chronic migraine.

BOTOX^® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX^®.  If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX^® if you: are allergic to any of the ingredients in BOTOX^®; had an allergic reaction to any other botulinum toxin product; have a skin infection at the planned injection site. Serious and/or immediate allergic reactions have been reported. Get medical help right away if you experience symptoms; further injection of BOTOX^® should be discontinued. Tell your doctor about all your muscle, nerve and medical conditions. Tell your doctor about all the medicines you take. Using BOTOX^® with certain other medicines may cause serious side effects. The most common side effects include neck pain and headache.

For more information, refer to the Medication Guide or talk with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see BOTOX^® full Product Information including Boxed Warning and Medication Guide.

About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at www.Allergan.com.

Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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SOURCE Allergan plc

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