AGN Allergan plc

DUBLIN, July 9, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today that the company will present 29 abstracts at the 61^st American Headache Society (AHS) Meeting, including one late-breaking podium presentation, five oral podium presentations and 23 poster presentations. The presentations will continue to highlight Allergan's ongoing innovation in the treatment and understanding of migraine disease, bringing forth new data and insights across its expanding migraine franchise.

With an expected FDA decision in Q4 2019, Allergan continues to highlight data from its pivotal trials for ubrogepant, an investigational oral CGRP receptor antagonist for the acute treatment of migraine. Allergan will present a total of 14 ubrogepant focused abstracts, including ubrogepant in patients ineffectively treated with triptans, the effectiveness and safety of a second optional dose in achieving pain freedom at 2 hours, the safety of ubrogepant in patients with moderate to high cardiovascular risk, and the onset of pain relief.

BOTOX^® (onabotulinumtoxinA) remains a mainstay in the preventive treatment space and is a first-line treatment for Chronic Migraine. BOTOX^® will be featured in several presentations focused on safety, efficacy, and healthcare resource utilization with data evaluating impact on headache severity, headache-related impact, and quality of life in responder and nonresponder subgroups, and reductions in healthcare resource utilization. In addition, preclinical data from a mechanism of action study will be presented. This study evaluated a potential Chronic Migraine treatment approach that combines BOTOX^® and atogepant, the company's second investigational, orally-administered CGRP receptor antagonist. Atogepant is currently in Phase III clinical trials for the prevention of migraine and will be highlighted in four abstracts at this year's meeting.

"The strength of our data at AHS reinforces Allergan's heritage and innovation in the migraine treatment space," said David Nicholson, Chief Research and Development Officer, Allergan. "With a wealth of presentations highlighting BOTOX^®, ubrogepant and atogepant, Allergan is proud to showcase our ongoing commitment to the scientific advancement of our migraine franchise – Allergan MIND™ – and to the migraine community at large." As part of Allergan's ongoing commitment to innovating and inspiring change in the migraine community, the company has established a migraine franchise, Allergan MIND™ (Migraine: Innovation, Navigation, Discovery), to drive progress and unify its efforts as a worldwide leader in migraine.

The following late-breaking platform presentation will be highlighted on Saturday, July 13^th at 11:30 AM ET:

• Extracranial injections of onabotulinumtoxinA in combination with intravenous injection of atogepant attenuates activation and sensitization of HT and WDR neurons by CSD. Authors: Agustin M, et al.

Oral podium presentations include:

• Demographics, Headache Characteristics, and Other Factors Associated With Opioid Use in People With Migraine: Results From the CaMEO Study. Authors: Lipton R, et al. Friday, July 12th, 12:10 PM ET. 
• Orally Administered Atogepant Was Efficacious, Safe, and Tolerable for the Prevention of Migraine: Results From a Phase 2b/3 Study. Authors: Goadsby P, et al. Saturday, July 13th, 8:00 AM ET.
• Ubrogepant is Effective for the Acute Treatment of Migraine in Patients for Whom Triptans are Ineffective. Authors: Blumenfeld AM, et al. Saturday, July 13th, 8:10 AM ET. (ePoster to be highlighted on Saturday, July 13^th from 1:30 PM – 1:35 PM ET)
• Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study Demonstrate a High Level of Unmet Need for Migraine Treatment in People Who Discontinue Acute Prescription Migraine Medication. Authors: Lipton R, et al. Saturday, July 13th, 9:20 AM ET.
• Characterization of the Effects of the Calcitonin Gene–Related Peptide (CGRP) Receptor Antagonists Atogepant and Ubrogepant on Isolated Human Coronary, Cerebral, and Middle Meningeal Arteries. Authors: Rubio-Beltran E, et al. Saturday, July 13th, 11:10 AM ET.

The following posters will be displayed on Friday, July 12^th from 1:15 PM – 2:15 PM ET:

• The Impact of OnabotulinumtoxinA vs Placebo on Efficacy Outcomes in Responder and Nonresponder Subgroups of Patients with Chronic Migraine: PREEMPT Pooled Analysis. Authors: Diener HC, et al. (ePoster to be highlighted on Saturday, July 13^th from 1:15 PM – 2:15 PM ET)
• Safety and Tolerability of Ubrogepant Following Intermittent, High Frequency Dosing. Authors: Goadsby P, et al. 
• Triptan Discontinuation and Treatment Patterns Among Migraine Patients Initiating Triptan Treatment in a US Commercially Insured Population. Authors: Marcus S, et al.
• Greater Headache-Related Burden and Disability Among Those with Medication Overuse: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Schwedt TJ, et al. (ePoster to be highlighted on Saturday, July 13^th from 1:50 PM – 1:55 PM ET)
• Health-Related Quality of Life Based on Response to Triptans in People With Migraine: Analysis of Real-World Data. Authors: Lipton RB, et al.
• Single Therapeutic Doses of Ubrogepant Are Not Associated with a Clinically Relevant Drug-Drug Interaction When Co-administered with Acetaminophen or Naproxen. Authors: Jakate A, et al. (ePoster to be highlighted on Saturday, July 13^th from 1:40 PM – 1:45 PM ET)
• Absence of Clinically Significant Drug Interactions With Coadministration of Ubrogepant and an Ethinyl Estradiol/Norgestimate Oral Contraceptive in Healthy Female Subjects: A Phase 1 Pharmacokinetic Analysis. Authors: Li CC, et al. (ePoster to be highlighted on Friday, July 12^th or Saturday, July 13^th from 1:15 PM – 2:15 PM ET)
• An Optional Second Dose of Ubrogepant is Effective in Achieving 2-Hour Pain Freedom in the Acute Treatment of Migraine. Authors: Ailani J, et al. (ePoster to be highlighted on Saturday, July 13^th from 1:10 PM – 1:15 PM ET)
• Safety and Efficacy of Ubrogepant in Participants with Moderate to High Cardiovascular Risk. Authors: Hutchinson S, et al. (ePoster to be highlighted on Friday, July 12^th or Saturday, July 13^th from 1:15 PM – 2:15 PM ET)
• Healthcare Resource Utilization in Adult Patients Treated with OnabotulinumtoxinA for Chronic Migraine: Results from the COMPEL Study. Authors: Rothrock JF, et al. (ePoster to be highlighted on Saturday, July 13^th from 1:15 PM – 1:20 PM ET)
• Ubrogepant for the Acute Treatment of Migraine: Pooled Safety and Tolerability from ACHIEVE I and ACHIEVE II Phase 3 Studies. Authors: Hutchinson S, et al. (ePoster to be highlighted on Saturday, July 13^th from 1:30 PM – 1:35 PM ET)
• Depression and Anxiety Are Associated With Increased Headache-Related Disability in Episodic and Chronic Migraine: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Lipton RB, et al. (ePoster to be highlighted on Saturday, July 13^th from 1:05 PM – 1:10 PM ET)
• Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults. Authors: Jakate A, et al. (ePoster to be highlighted on Friday, July 12^th from 1:40 PM – 1:45 PM ET)

The following posters will be displayed on Saturday, July 13^th from 1:00 PM – 2:15 PM ET:

• Characterization of Ubrogepant: A Potent and Selective Antagonist of the Human Calcitonin Gene‒Related Peptide Receptor. Authors: Moore E, et al. 
• Responder Rates to Atogepant in Patients With Episodic Migraine: A Post Hoc Analysis of Results From a Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled Trial. Authors: Dodick DW, et al.
• Opioid Use, Rebound Headache, and Resource Utilization Among Migraine Patients With Insufficient Response to Triptans Based on Real-World Data. Authors: Silberstein SD, et al. (ePoster to be highlighted on Friday, July 12^th from 1:25 PM – 1:30 PM ET)
• Analysis of Treatment Change of Acute Prescription Migraine Medications Using Real-World Evidence. Authors: Lipton RB, et al. (ePoster to be highlighted on Friday, July 12^th from 1:30 PM – 1:35 PM ET)
• Coadministration of Single Therapeutic Oral Doses of Ubrogepant and Sumatriptan Produces No Clinically Relevant Pharmacokinetic Interactions. Authors: Jakate A, et al. (ePoster to be highlighted on Friday, July 12^th from 1:45 PM – 1:50 PM ET)
• Absence of Clinically Significant Drug Interactions With Coadministration of Atogepant and an Ethinyl Estradiol/Levonorgestrel Oral Contraceptive in Healthy Female Subjects: A Phase 1 Pharmacokinetic Analysis. Authors: Ankrom W, et al. (ePoster to be highlighted on Friday, July 12^th or Saturday, July 13^th from 1:15 PM – 2:15 PM ET)
• Ubrogepant Achieves Early Pain Relief for the Acute Treatment of Migraine. Authors: Dodick DW, et al.
• Long-term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine Attacks. Authors: Ailani J, et al. (ePoster to be highlighted on Friday, July 12^th from 1:25 PM – 1:30 PM ET)
• Efficacy is Maintained with Long-term Intermittent Use of Ubrogepant for the Acute Treatment of Migraine. Authors: Lipton RB, et al. (ePoster to be highlighted on Friday, July 12^th from 1:40 PM – 1:45 PM ET)
• OnabotulinumtoxinA Is Safe and Effective in Patients Who Discontinue Topiramate: Results of the FORWARD Study. Authors: Rothrock JF, et al. (ePoster to be highlighted on Friday, July 12^th from 1:40 PM – 1:45 PM ET)

Indication

BOTOX^® is a prescription medicine that is injected into muscles and used:

• 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 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 its ingredients (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc^® (rimabotulinumtoxinB), Dysport^® (abobotulinumtoxinA), or Xeomin^® (incobotulinumtoxinA); have a skin infection at the planned injection site.

The dose of BOTOX^® is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX^® should be discontinued.

Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX^®.

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX^® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX^® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX^® with certain medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you received BOTOX^® in the past.

Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc^®, Dysport^®, or Xeomin^® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX^® include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, and dry eyes; drooping eyebrows.

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 Ubrogepant 
Ubrogepant is an orally-administered CGRP receptor antagonist in development for the acute treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. CGRP receptor antagonism is a novel mechanism of action for the acute treatment of migraine that differs from the mechanisms of currently available triptans (serotonin 1B/1D agonists), opioids and ergots.

About Atogepant
Atogepant is an orally-administered CGRP receptor antagonist in development for the prevention of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. It is chemically distinct from ubrogepant, our investigational orally-administered CGRP receptor antagonist for the acute treatment of migraine, and has demonstrated in preclinical studies to have a higher potency and longer half-life, making it potentially suitable for preventive treatment.

About Migraine Disease
Migraine is a chronic disease with episodic attacks defined by neurological symptoms such as headache pain, sensitivity to light and sound, and nausea; these symptoms are often incapacitating. Migraine is highly prevalent, affecting approximately 1 in 7 individuals, and is associated with significant disability leading to high personal, family, societal, and economic burden. Despite its prevalence and the availability of treatments, migraine is an underdiagnosed and undertreated disease. There is a need for new treatments for migraine with improved benefit-risk profiles to fulfill this unmet need.

Allergan, a leader in the migraine space, markets BOTOX® (onabotulinumtoxinA) the first 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 acute treatment and prevention of migraine. The U.S. FDA has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults, and a PDUFA date is expected in the fourth quarter of 2019. Ubrogepant is expected to be the first oral CGRP receptor antagonist to market. In addition, atogepant is currently in Phase 3 development for the prevention of migraine.

About Allergan MIND™ 
As part of Allergan's ongoing commitment to innovating and inspiring change in the migraine community, the company has established a migraine franchise, Allergan MIND™ (Migraine: Innovation, Navigation, Discovery), to drive progress and unify its efforts as a worldwide leader in migraine. Allergan MIND™ represents the company's vision and mission to continue advancing science and improving the lives of people living with migraine disease with treatments, education and support in the pursuit of migraine freedom. This new migraine franchise serves as a center of excellence and catalyst for advancing the dialogue and treatment landscape in migraine, bringing together diverse stakeholders to rally around the latest insights and developments that will impact the future of migraine.

About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader 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 primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located 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; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, 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, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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