News Releases

DUBLIN, May 2, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that they will showcase new data during the upcoming American Psychiatric Association (APA) Annual Meeting in New York City from May 5 to May 9, 2018. The company will present eight posters highlighting new data and clinical research across schizophrenia, bipolar I disorder, and major depressive disorder (MDD) therapeutic areas as part of the company's efforts towards advancing scientific discovery for underserved patient populations. The APA poster presentations will feature data for cariprazine, rapastinel and onabotulinumtoxinA.

Separately, at the Society of Biological Psychiatry (SOBP) Annual Meeting in New York City from May 10 to May 12, 2018, Allergan and Gideon Richter Plc. will also be presenting three original abstracts, including two late-breaking posters. These presentations will feature preclinical data for cariprazine and rapastinel, an investigational treatment for MDD.

"At this year's APA Annual Meeting, we are excited to share results from a range of studies that reinforce the wealth of data in our mental health portfolio, including across schizophrenia, bipolar I disorder and MDD," said David Nicholson, Chief Research & Development Officer at Allergan. "Mental health has and continues to be a key priority for Allergan, particularly given the need for additional treatment options in this space. We look forward to presenting our data at the meeting and working to continue building up our portfolio – with the goal of ultimately providing more options to the patients that need it most."

New cariprazine findings for bipolar I disorder, negative symptoms of schizophrenia and schizophrenia relapse will be debuted in four poster presentations at APA. The titles of the poster presentations are as follows:

Monday, May 7, 2018

• Potential Relationship Between Relapse and Plasma Drug Levels Following Discontinuation of Cariprazine Treatment in Patients With Schizophrenia (#P5-123). Presented by Christoph U. Correll (10:00 a.m. – 12:00 p.m. ET, Hall 3B, Third Level, Javits Center).
• Long-Term Effects of Cariprazine in Patients with Negative Symptoms of Schizophrenia: A Post Hoc Analysis of Two 48-Week, Open-Label Studies (#P6-151). Presented by Joseph McEvoy (2:00 p.m. – 4:00 p.m. ET, Hall 3B, Third Level, Javits Center).

Tuesday, May 8, 2018

• Cariprazine for the Treatment of Bipolar Mania with Mixed Features: A Post Hoc Pooled Analysis of 3 Trials (#P7-062). Presented by Prakash Masand (10:00 a.m. – 12:00 p.m. ET, Hall 3B, Third Level, Javits Center).
• Consistent Efficacy of Cariprazine Across PANSS-based Factor Scores for Negative Symptoms of Schizophrenia (#P8-164). Presented by Willie Earley (2:00 – 4:00 p.m. ET, Hall 3B, Third Level, Javits Center).

Four poster presentations at APA will highlight research in MDD, including new data for rapastinel, Allergan's investigational antidepressant, and data evaluating the investigational use of onabotulinumtoxinA as an antidepressant. The titles of the poster presentations are as follows:

Monday, May 7, 2018

• Treatment and Rehospitalization Patterns of Patients Hospitalized for Major Depressive Disorder (#P5-066). Presented by Kenneth Kramer (10:00 a.m. – 12:00 p.m. ET, Hall 3B, Third Level, Javits Center).
• Rapastinel, a Rapid-Acting Antidepressant, Does Not Adversely Affect Cortical Network Oscillations: A Quantitative EEG Study in Rats (#P5-065). Presented by Kelly Krogh (10:00 a.m. – 12:00 p.m. ET, Hall 3B, Third Level, Javits Center).

Tuesday, May 8, 2018

• Treating Major Depressive Disorder with OnabotA: Safety and Efficacy 24 Weeks Following a Single Injection Session (#P7-063). Presented by Armin Szegedi (10:00 a.m. – 12:00 p.m. ET, Hall 3B, Third Level, Javits Center).
• Characterizing the Prevalence and Characteristics of Major Depressive Disorder (MDD)-Related Hospitalizations in US Patients Diagnosed With MDD (#P8-053). Presented by Amy Tung (2:00 – 4:00 p.m. ET, Hall 3B, Third Level, Javits Center).

Three poster presentations at SOBP will highlight preclinical studies evaluating the underlying mechanism of action for cariprazine and the potential mechanism of action for rapastinel. The titles of the poster presentations are as follows:

Thursday, May 10, 2018

• Low doses of the dopamine D2/D3 receptor partial agonist cariprazine enhances motivation in mice (#T386). Late-breaking poster presented by Elke Schipani (5:00 – 7:00 p.m. ET, Americas Hall I).
• Mechanisms Underlying the Rapid Antidepressant Actions of Rapastinel: Role and Regulation of NMDA Receptor Subunits (#T321). Late-breaking poster presented by Santosh Pothula (Poster Session 1, 5:00 – 7:00 p.m. ET, Americas Hall I).
• Cariprazine Enhances Monoaminergic Activity in the Hippocampus and Ventral Striatum of Rats: A Possible Basis for its Antipsychotic Effect (#T255). Presented by Herbert Y Meltzer (Poster Session 1, 5:00 – 7:00 p.m. ET, Americas Hall I).

INDICATION AND USAGE

VRAYLAR (cariprazine) is indicated in adults for the acute treatment of manic or mixed episodes of bipolar I disorder and for the treatment of schizophrenia.

Contraindication: VRAYLAR is contraindicated in patients with known hypersensitivity. Reactions have included rash, pruritus, urticaria, and events suggestive of angioedema.

Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials with antipsychotic drugs, elderly subjects with dementia had a higher incidence of cerebrovascular adverse reactions, including fatalities vs placebo. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with antipsychotic drugs. NMS may cause hyperpyrexia, muscle rigidity, delirium, and autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.  Manage with immediate discontinuation, intensive symptomatic treatment, and monitoring.

Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible may increase with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. If signs and symptoms of TD appear, drug discontinuation should be considered.

Late-Occurring Adverse Reactions: Adverse events may first appear several weeks after initiation of VRAYLAR, probably because plasma levels of cariprazine and its major metabolites accumulate over time. As a result, the incidence of adverse reactions in short-term trials may not reflect the rates after longer term exposures. Monitor for adverse reactions, including extrapyramidal symptoms (EPS) or akathisia, and patient response for several weeks after starting VRAYLAR and after each dosage increase. Consider reducing the dose or discontinuing the drug.

Metabolic Changes: Atypical antipsychotics have caused metabolic changes, such as:

• Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Assess fasting glucose before or soon after initiation of treatment, and monitor periodically during long-term treatment.
• Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after starting an antipsychotic, obtain baseline fasting lipid profile and monitor periodically during treatment.
• Weight Gain: Weight gain has been observed with VRAYLAR. Monitor weight at baseline and frequently thereafter.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia have been reported with antipsychotics, including VRAYLAR. Agranulocytosis (including fatal cases) has been reported with other antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue VRAYLAR at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope, with the greatest risk during initial titration and with dose increases. Monitor orthostatic vital signs in patients predisposed to hypotension and in those with cardiovascular/cerebrovascular diseases.

Falls: VRAYLAR may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures, or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotics and recurrently for patients on long-term therapy.

Seizures: Use VRAYLAR with caution in patients with history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: Somnolence was reported with VRAYLAR. Caution patients about performing activities requiring mental alertness (eg, operating hazardous machinery or a motor vehicle).

Body Temperature Dysregulation: Use VRAYLAR with caution in patients who may experience conditions that increase body temperature (eg, strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics).

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics. Antipsychotic drugs, including VRAYLAR, should be used cautiously in patients at risk for aspiration.

Drug Interactions: Strong CYP3A4 inhibitors increase VRAYLAR concentrations, so VRAYLAR dose reduction is recommended. Concomitant use with CYP3A4 inducers is not recommended.

Adverse Reactions: In clinical trials, the most common adverse reactions (≥5% and at least twice the rate of placebo) are listed below:

• Schizophrenia: The incidences within the recommended dose range (VRAYLAR 1.5 – 3 mg/day and 4.5 – 6 mg/day vs placebo) were: EPS (15%, 19% vs 8%) and akathisia (9%, 13% vs 4%)
• Bipolar mania: The incidences within the recommended dose range (VRAYLAR 3 – 6 mg/day vs placebo) were: EPS (26% vs 12%), akathisia (20% vs 5%), dyspepsia (7% vs 4%), vomiting (10% vs 4%), somnolence (7% vs 4%), and restlessness (7% vs 2%)

Please also see full Prescribing Information, including Boxed Warning.

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.

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; 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. 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

Karina Calzadilla
(862) 261- 7328

Media:
Amy Rose
(862) 289-3072

Fran DeSena
(862) 261-8820

SOURCE Allergan plc