Actavis Launches NAMZARIC™ (memantine hydrochloride extended-release and donepezil hydrochloride), a Fixed-Dose Combination Therapy for the Treatment of Moderate to Severe Alzheimer's Disease

- NAMZARIC is now available across the United States -

May 18, 2015, 08:00 ET from Actavis plc

DUBLIN, Ireland, May 18, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that NAMZARIC™ (memantine hydrochloride extended-release and donepezil hydrochloride), a once-daily, fixed-dose combination of memantine hydrochloride extended-release (a NMDA receptor antagonist), and donepezil hydrochloride (an acetylcholinesterase inhibitor), is now available to patients and healthcare professionals across the United States. NAMZARIC was approved by the U.S. Food and Drug Administration (FDA) in December for the treatment of moderate to severe Alzheimer's disease in patients stabilized on memantine hydrochloride and donepezil hydrochloride.

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"We're excited to make once-daily NAMZARIC available as another treatment option for patients with moderate to severe Alzheimer's disease," said Bill Meury, Actavis President, Branded Pharma. "Since the launch of NAMENDA XR® (memantine hydrochloride) in 2013, the two medications, NAMENDA XR and donepezil, have been commonly prescribed in combination with one another to treat the symptoms of moderate to severe Alzheimer's disease. NAMZARIC offers an option with the benefits of both treatments, while reducing the number of pills a patient and their caregivers need to administer each day, to treat this disease."

"We are pleased that NAMZARIC is now available for patients who face the challenges associated with moderate to severe Alzheimer's disease," said Gregory T. Went, Ph.D., Chairman and CEO of Adamas Pharmaceuticals, Inc. "Actavis and Adamas have worked together to create this new fixed-dose combination therapy, the second product from our collaboration. We believe NAMZARIC provides patients and their caregivers with a much needed and more convenient treatment option."

About NAMZARICNAMZARIC is a once-daily, fixed-dose combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. NAMZARIC will be available in two dosage strengths, 28/10 mg (memantine HCl extended-release/donepezil HCl) and 14/10mg (memantine HCl extended-release/donepezil HCl) for patients with severe renal impairment. Memantine hydrochloride extended-release is the active ingredient in the currently marketed NAMENDA XR®, which is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Donepezil is the active ingredient in ARICEPT® (donepezil hydrochloride), which is indicated for the treatment of mild to severe dementia of the Alzheimer's type. Actavis and Adamas collaborated on the development of the fixed-dose combination and Actavis will have exclusive U.S. commercialization rights, while Adamas will retain exclusive commercialization rights outside of the U.S.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS NAMZARIC is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.

WARNINGS AND PRECAUTIONS

  • Anesthesia: NAMZARIC is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
  • Cardiovascular Conditions: NAMZARIC may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block. Bradycardia or heart block may manifest in patients both with and without known underlying cardiac conduction abnormalities.
  • Peptic Ulcer Disease and Gastrointestinal Bleeding: Patients treated with NAMZARIC should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, those with a history of ulcer disease, or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Nausea and Vomiting: NAMZARIC can cause diarrhea, nausea, and vomiting, although in most cases these effects have been mild and transient, and have resolved during continued treatment.
  • Genitourinary Conditions: NAMZARIC may cause bladder outflow obstructions. Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine.
  • Seizures: Cholinomimetics, including donepezil hydrochloride, are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer's disease.
  • Pulmonary Conditions: Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

ADVERSE REACTIONS

  • The most common adverse reactions, occurring at a frequency of at least 5% in patients taking memantine hydrochloride extended release 28 mg/day, and greater than placebo, were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
  • The most common adverse reactions, occurring at a frequency of at least 5% in patients taking donepezil, and at twice or more the rate of placebo, include diarrhea (10% vs 4%), anorexia (8% vs 4%), vomiting (8% vs 4%), nausea (6% vs 2%), and ecchymosis (5% vs 2%).

DRUG INTERACTIONS

  • Alterations of urine pH toward the alkaline condition may lead to an accumulation of memantine with a possible increase in adverse reactions. NAMZARIC should be used with caution under conditions that may be associated with increased urine pH including alterations by diet and the clinical state of the patient.
  • The combined use of memantine hydrochloride with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution.
  • Inhibitors of CYP450, 3A4 (e.g., ketoconazole) and 2D6 (e.g., quinidine), inhibit donepezil metabolism in vitro. Whether there is a clinical effect of quinidine is not known.
  • Inducers of CYP3A4 (e.g., phenytoin, carbamazepine, dexamethasone, rifampin, and phenobarbital) could increase the rate of elimination of donepezil.
  • Cholinesterase inhibitors, including donepezil hydrochloride, have the potential to interfere with the activity of anticholinergic medications.

DOSAGE AND ADMINISTRATION

  • Patients stabilized on memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily and donepezil hydrochloride 10 mg) can be switched to NAMZARIC 28 mg/10 mg, taken once a day in the evening. Patients should start NAMZARIC the day following the last dose of memantine hydrochloride and donepezil hydrochloride administered separately.
  • Patients with severe renal impairment (creatinine clearance 5-29 mL/min, based on the Cockcroft-Gault equation), stabilized on memantine hydrochloride (5 mg twice daily or 14 mg extended-release once daily) and donepezil hydrochloride 10 mg, can be switched to NAMZARIC 14 mg/10 mg, taken once daily.

About Alzheimer's Alzheimer's disease is a progressive, neurodegenerative disorder characterized by problems with memory, thinking and behavior that eventually become severe enough to affect daily tasks. An estimated 5.2 million people in the United States are currently living with Alzheimer's disease. Alzheimer's disease is the fifth leading cause of death in the United States among those aged 65 and older and was reported as an underlying cause of death for more than 83,000 Americans in 2010.

About Adamas Pharmaceuticals Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. Adamas is currently developing its lead wholly-owned product candidate, ADS-5102, for a complication associated with the treatment of Parkinson's disease known as levodopa-induced dyskinesia, or LID, and is evaluating other potential indications. The company's portfolio also includes two approved products with Forest Laboratories Holdings Limited (a subsidiary of Actavis plc), Namzaric™ and Namenda XR®. Forest is responsible for marketing both products in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com.

About Actavis Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Actavis is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high quality generic and over-the-counter medicines and biologic products for patients around the world.  In March 2015, Actavis plc acquired Allergan.

Actavis markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Actavis is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Actavis 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.

Actavis intends to adopt a new global name – Allergan – pending shareholder approval in 2015.

For more information, visit Actavis' website at www.actavis.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 Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' 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 Actavis' products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

ACTAVIS CONTACTS: Investors:

Lisa DeFrancesco (862) 261-7152

Media:

David Belian (862) 261-8141

SOURCE Actavis plc



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