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09.06.2017 | Investors

Allergan to Present New Data on Chronic Migraine at the International Headache Congress in Vancouver

DUBLIN, Sept. 6, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that data on Chronic Migraine and the Company's Chronic Migraine treatment will be featured in 11 presentations at the upcoming 18th Congress of the International Headache Society (IHC2017) taking place September 7-10, 2017 in Vancouver, BC.

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Among the highlights are one oral podium presentation and two poster presentations on Chronic Migraine disease awareness from the CaMEO and PREDICT studies, as well as one poster on migraine treatment patterns and opioid use among episodic and Chronic Migraine patients and one poster evaluating the Identify Chronic Migraine (ID-CM) screener in an accountable care organization. Additionally, Allergan will be presenting six posters from the COMPEL, FORWARD and REPOSE studies containing data on the safety, efficacy and real-world effectiveness for BOTOX® treatment for Chronic Migraine.

"The data being presented at IHC2017 underscores Allergan's dedication and investment to advancing the science of migraine through ongoing research," said David Nicholson, Chief Research & Development Officer at Allergan. "We are proud to be at the forefront of  progressing research and treatment options for the millions of Americans living with migraine."

Allergan, a leader in the Chronic Migraine space, markets BOTOX® (onabotulinumtoxinA) the first and only FDA-approved, 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 CGRPs, ubrogepant in Phase III for the acute treatment of migraine and atogepant in Phase II for the prevention of migraine, are expected to be the first oral CGRP receptor antagonists to market.

The scheduled times (noted in local Pacific Time) of the presentations and locations are as follows:

  • A Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of OnabotulinumtoxinA and Topiramate for Headache Prophylaxis in Adults with Chronic Migraine: The FORWARD Study
    • Authors: Rothrock J, Manack Adams A, Jo E, Zhao X, Blumenfeld AM
    • Poster Presentation, PO-01-185
    • Thurs, 9/7 - Fri, 9/8 (all day)
  • Migraine Treatment Patterns and Opioid Use Among Chronic and Episodic Migraine Patients Identified by a Clinician-Administered Semi-Structured Diagnostic Interview
    • Authors: Yu JS, Pavlovic JM, Silberstein SD, Reed ML, Kawahara SH, Cowan RP, Dabbous F, Campbell KL, Pulicharam R, Kowalski J, Viswanathan HN, Lipton RB
    • o   Poster Presentation, PO-02-176
    • o   Sat, 9/9 - Sun, 9/10 (all day)
  • Real-Life Use of OnabotulinumtoxinA for the Symptomatic Treatment of Chronic Migraine: The REPOSE Study
    • o   Authors: Ahmed F, Gaul C, Martelletti P, García-Moncó J, Manack Adams A
    • o   Poster Presentation, PO-01-066
    • o   Thurs, 9/7 - Fri, 9/8 (all day)
  • Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Chronic Migraine Patients: COMPEL Analysis by Treatment Cycle
    • o    Authors: Winner P, Blumenfeld A, Eross E, Orejudos A, Manack Adams A, Brin M
    • o    Poster Presentation, PO-01-065
    • o    Thurs, 9/7 - Fri, 9/8 (all day)
  • Effects of OnabotulinumtoxinA Treatment on Disability and Quality of Life in Patients with Chronic Migraine with Baseline Headache Every Day: A COMPEL Subanalysis
    • o    Authors: Lopez J, Blumenfeld A, Young W, Manack Adams A, Rothrock J
    • o    Poster Presentation, PO-01-074
    • o    Thurs, 9/7 - Fri, 9/8 (all day)
  • Effects of OnabotulinumtoxinA Treatment on Disability and Quality of Life in Patients with Chronic Migraine with Baseline Allodynia: A COMPEL Subanalysis
    • o    Authors: Young W, Lopez J, Rothrock J, Manack Adams A, Blumenfeld A
    • Poster Presentation, PO-01-075
    • o    Thurs, 9/7 - Fri, 9/8 (all day)
  • Impact of Chronic Migraine on Health Resource Utilization, Quality of Life, and Work Productivity: Baseline Results from a Prospective, Observational Study (PREDICT)
    • o    Boudreau G, Becker WJ, Graboski C, Ong-Lam M, Stewart B, Davidovic G
    • o    Poster Presentation, PO-01-081
    • o    Thurs, 9/7 - Fri, 9/8 (all day)
  • Effects of OnabotulinumtoxinA Treatment on Chronic Migraine Comorbidities of Depression and Anxiety
    • o    Authors: Blumenfeld A, Tepper S, Robbins L, Manack Adams A, Silberstein S
    • o    Poster Presentation, PO-02-028
    • o    Sat, 9/9 - Sun, 9/10 (all day)
  • The Relationship Between Sleep Disorders and Migraine: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study
    • o    Authors: Buse D, Rains J, Pavlovic J, Fanning K, Reed M, Manack Adams A, Lipton R
    • o    Poster Presentation, PO-02-027
    • o    Sat, 9/9 - Sun, 9/10 (all day)
  • Evaluation of the Identify Chronic Migraine (ID-CM) screener in an accountable care organization
    • o    Authors: Yu J, Pavlovic J, Silberstein S, Reed M, Kawahara S, Cowan R, Dabbous F, Campbell K, Pulicharam R, Viswanathan H, Lipton R
    • o    Poster Presentation, EP-02-023
    • o    Sat, 9/9 - Sun, 9/10 (all day); Poster Walk: Sat, 9/9, 10:00 AM -10:45 AM or 15:15 PM -16:00 PM
  • Medical Comorbidities of Migraine: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study
    • o    Authors: Lipton R, Martin V, Reed M, Fanning K, Manack Adams A, Buse D, Goadsby P
    • o    Podium Presentation, OC-EP-001
    • o    Sun, 9/10; 8:00 AM - 8:12 AM

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 take 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.

Allergan's Commitment to People with Migraine
Allergan is committed to advancing the science of migraine through ongoing research and clinical investment, while providing innovative treatment approaches, educational opportunities, and support services that improve the lives of patients. Allergan tirelessly pursues freedom from migraine in partnership with the entire migraine community.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. 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 with 65+ mid-to-late stage pipeline programs currently in development.

Allergan's success is powered by our more than 18,000 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; 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, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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