Allergan to Present New Data on BYSTOLIC® (nebivolol) at Annual American Heart Association Meeting (AHA) in New Orleans

DUBLIN, Nov. 12, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company today announced that data on nebivolol will be presented at the American Heart Association (AHA) Annual Scientific Meeting scheduled November 12-16th, 2016 in New Orleans, Louisiana, at the Ernest N. Morial Convention Center. Nebivolol is approved and marketed in the US as BYSTOLIC for the treatment of hypertension to lower blood pressure.

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"Hypertension is associated with serious cardiovascular risks and represents a significant public health issue," said Gavin Corcoran, Chief Medical Officer at Allergan.  "We are pleased to support health outcomes and clinical research to elucidate the role nebivolol may play in managing this costly and burdensome condition."

The posters include data from two hypertension studies. The scheduled times and titles of the presentations are as follows:

Poster Presentations:   

"Cardiovascular Outcomes with Nebivolol, Atenolol and Metoprolol in Patients with Hypertension: A Large Retrospective Cohort Study"

• Presenter: Alan Gradman
• Program #: P55385
• Date/Time: Monday, November 14^th, 10:45 AM – 12:00 PM CT
• Location: Science and Technology Hall (Population Science Section)

"A Double-Blinded, placebo-controlled, randomized study examining nebivolol compared to atenolol on endothelial function and cardiovascular risk in patients with early vascular disease (EVIDENCE)"

• Presenter: Daniel Duprez
• Program #:  P54746 
• Date/Time: Tuesday, November 15^th, 10:45 AM – 12:00 PM CT
• Location: Science and Technology Hall (Clinical Science Section)

About Bystolic®   
Nebivolol (marketed in the U.S. as BYSTOLIC®) is indicated for the treatment of hypertension and may be used alone or in combination with other antihypertensive agents.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nebivolol.

Nebivolol is a cardioselective beta blocker up to and including the 10mg dose and in extensive metabolizers. While nebivolol's mechanism of action has not been definitively established, possible factors that may be involved include vasodilation, decreased peripheral vascular resistance, reduced heart rate and myocardial contractility, suppression of renin, and reduced sympathetic activity.

MPORTANT SAFETY INFORMATION FOR BYSTOLIC

Contraindications

• BYSTOLIC is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.

Warnings and Precautions

• Do not abruptly discontinue BYSTOLIC therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction, and ventricular arrhythmias have been reported following the abrupt discontinuation of therapy with beta blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Caution patients without overt coronary artery disease against interruption or abrupt discontinuation of therapy. As with other beta blockers, when discontinuation of BYSTOLIC is planned, carefully observe and advise patients to minimize physical activity. Taper BYSTOLIC over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, restart BYSTOLIC promptly, at least temporarily.
• BYSTOLIC was not studied in patients with angina pectoris or who had a recent MI. In general, patients with bronchospastic diseases should not receive beta blockers.
• Because beta blocker withdrawal has been associated with an increased risk of MI and chest pain, patients already on beta blockers should generally continue treatment throughout the perioperative period. If BYSTOLIC is to be continued perioperatively, monitor patients closely when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene are used. If beta-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. 
• The beta-blocking effects of BYSTOLIC can be reversed by beta agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with beta blockers.
• Beta blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Advise patients subject to spontaneous hypoglycemia and diabetic patients receiving insulin or oral hypoglycemic agents about these possibilities.
• Beta blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta blockers in these patients may be followed by an exacerbation of symptoms or may precipitate a thyroid storm.
• Beta blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
• Because of significant negative inotropic and chronotropic effects in patients treated with beta blockers and calcium channel blockers of the verapamil and diltiazem type, monitor the ECG and blood pressure of patients treated concomitantly with these agents.
• When BYSTOLIC is co-administered with an inhibitor or an inducer of CYP2D6, monitor patients closely and adjust the nebivolol dose according to blood pressure response. The dose of BYSTOLIC may need to be reduced. When BYSTOLIC is administered with fluoxetine, significant increases in d-nebivolol may be observed (i.e., an 8-fold increase in AUC and a 3-fold increase in C_max for d-nebivolol).
• Renal clearance of nebivolol is decreased in patients with severe renal impairment. In patients with severe renal impairment (ClCr less than 30 mL/min) the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients receiving dialysis.
• Metabolism of nebivolol is decreased in patients with moderate hepatic impairment. In patients with moderate hepatic impairment, the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. BYSTOLIC has not been studied in patients with severe hepatic impairment and therefore it is not recommended in that population.
• Patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenge and may be unresponsive to the usual doses of epinephrine while taking beta blockers.
• In patients with known or suspected pheochromocytoma, initiate an alpha blocker prior to the use of any beta blocker.

Adverse Reactions

• The most common adverse events with BYSTOLIC versus placebo (approximately ≥1% and greater than placebo) were headache, fatigue, dizziness, diarrhea, nausea, insomnia, chest pain, bradycardia, dyspnea, rash, and peripheral edema. The most common adverse events that led to discontinuation of BYSTOLIC were headache (0.4%), nausea (0.2%), and bradycardia (0.2%).

Drug Interactions

• Use caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.).
  • Do not use BYSTOLIC with other beta blockers.
  • Both digitalis glycosides and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
  • BYSTOLIC can exacerbate the effects of myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide.

Use in Specific Populations

• Use BYSTOLIC during pregnancy only if the potential benefit justifies the potential risk to the fetus. BYSTOLIC is not recommended during nursing.
• The safety and effectiveness of BYSTOLIC have not been established in pediatric patients.
• In a placebo-controlled trial of 2128 patients (1067 BYSTOLIC, 1061 placebo) over 70 years of age with chronic heart failure receiving a maximum dose of 10 mg per day for a median of 20 months, no worsening of heart failure was reported with nebivolol compared to placebo. However, if heart failure worsens, consider discontinuation of BYSTOLIC.

Please also see the full Prescribing Information for Bystolic at BystolicHCP.com

About Hypertension  
According to the U.S. Centers for Disease Control and Prevention, hypertension has been called the "silent killer" because it often has no warning signs or symptoms and has been associated with serious cardiovascular (CV) risks, such as stroke and myocardial infarction. Hypertension represents a significant public health issue with high prevalence in the United States. According to the National Institute for Health Statistics, approximately 30 percent of adults in the U.S. have hypertension. Inadequate control of hypertension is a significant public health problem, with approximately half of all patients still not achieving target goals. Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce CV morbidity and mortality, and it can be concluded that it is blood pressure reduction that is largely responsible for those benefits  In addition, approximately two-thirds of hypertensive patients will require more than one drug to achieve blood pressure goals,.

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 pharmaceuticals, devices and biologic 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, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care.  This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Allergan 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 of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. 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, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:      

Investors:   
Lisa DeFrancesco   
(862) 261-7152

Media:    
Mark Marmur  
(862) 261-7558

Fran DeSena  
(973) 517-3132

SOURCE Allergan plc

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