Allergan's Migraine Leadership Recognized with Enrico Greppi Award for Excellence in Headache Research

DUBLIN, Nov. 29, 2017 /PRNewswire/ -- Allergan plc, AGN, a leading global pharmaceutical company, is pleased to announce that its manuscript, "Fluctuations in Episodic and Chronic Migraine Status Over the Course of One Year: Implications for Diagnosis, Treatment and Clinical Trial Design," has been selected as the 2017 Enrico Greppi Award Winner. The Italian Society for the Study of Headaches (SISC) grants the annual Award to the best unpublished original paper dealing with clinical, epidemiological, genetic, pathophysiological or therapeutic aspects of headache, in memory of Enrico Greppi, a pioneer and expert in the study of headache.

"We are honored to receive this prestigious award and the recognition of the importance of gaining a data-driven understanding of chronic migraine to improve classification, diagnosis and clinical trial design," says Richard Lipton, MD, Vice Chair of Neurology, Albert Einstein College of Medicine, and an author on the paper. "There is a traditional bright line of 15 headache days that separates people with episodic migraine from those with chronic migraine, but people with migraine experience striking fluctuations in the frequency of their headache attacks. Therefore, days alone may not be sufficiently stable to distinguish between episodic and chronic migraine. More data is needed to fully understand the underlying biological differences."

The award-winning manuscript, which was published in The Journal of Headache and Pain and will be presented at the 11th European Headache Federation (EHF) Congress in Rome, includes findings from the longitudinal Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, which recruited nearly 17,000 individuals with migraine from a web-based panel, to complete a series of surveys for more than one year. It was purposely designed to characterize natural migraine disease course; quantify its societal, familial, and economic impact; and provide an evidence-based foundation to improve migraine care.

"For decades, Allergan has been investing in research that continues to uncover new data about headache medicine and improve our understanding of the disease. We're proud to be recognized with this prestigious award and share our latest data on a global stage," said David Nicholson, Chief Research & Development Officer at Allergan. "We congratulate the authors on this honor and are grateful for their shared commitment to the future of headache research."

Allergan will also present six additional abstracts on Chronic Migraine and the Company's Chronic Migraine treatment. Beyond the award lecture, highlights include three podium presentations on findings from the CaMEO study on comorbidities of migraine, the REPOSE study on the safety and effectiveness of BOTOX^® (onabotulinumtoxinA) for the treatment of Chronic Migraine, and the FORWARD study comparing the tolerability profile of BOTOX^® and topiramate for the preventive treatment of Chronic Migraine. Allergan will also present four posters containing data from CaMEO and FORWARD studies, and the diagnosis of patients with Chronic Migraine.

The following presentations will take place at the 11th European Headache Federation (EHF) Congress in Rome from December 1-3, 2017:

• Fluctuations in Episodic Chronic Migraine Status Over the Course of One Year: Implications for Diagnosis, Treatment, and Clinical Trial Design (Greppi Award Winner). Authors: Serrano D, et al [Oral Presentation]
• The Relationship Between Pain, Psychiatric, and Endocrine/Neurological Comorbidities of Migraine: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Lipton RB, et al. [Oral Presentation]
• Real-life Use of OnabotulinumtoxinA for the Symptomatic Treatment of Chronic Migraine: The REPOSE Study. Authors: Ahmed F, et al. [Oral Presentation]
• 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 JF, et al. [Oral Presentation & E-Poster]
• The Relationship Between Sleep Disorders and Migraine: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Buse DC, et al. [E-Poster]
• Medical (Respiratory, Sleep, Cardiovascular and Gastrointestinal) Comorbidities of Migraine: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Lipton RB, et al. [E-Poster]
• Development of a Claims-based Algorithm for Use in Patients with Migraine to Identify Potentially Undiagnosed Chronic Migraine Patients. Authors: Pavlovic JM, et al. [E-Poster]

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.

Funding for the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study was provided by Allergan plc.

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.

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 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 55+ 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; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS^®, on our financial results; 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, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended September 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:      

Allergan:

Investors:
Daphne Karydas
(862) 261-8006

Media:
Mark Marmur
(862) 261-7558

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