Actavis and Adamas Announce FDA Approval of Namzaric™, a Fixed-Dose Combination of Memantine Extended-Release and Donepezil Hydrochloride

DUBLIN and EMERYVILLE, Calif., Dec. 24, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) and Adamas Pharmaceuticals Inc. (NASDAQ: ADMS) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. Namzaric was approved for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride.

Logo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO

"Namzaric combines, in one capsule, two complementary therapeutic agents which are often co-prescribed as approximately 70% of Namenda XR patients are also on AChEI therapy.  Both Namenda XR and donepezil have proven efficacy and safety, for the treatment of moderate to severe Alzheimer's disease. Additionally, data has shown that combination therapy with Namenda XR and an AChEI demonstrated greater improvement in cognition and global function verses an AChEI alone," said David Nicholson, Actavis Senior Vice President, Global Brands R&D. "Along with our partner Adamas, we are proud that this important therapy will provide a convenient and innovative treatment option for Alzheimer's patients and caregivers that reduces the number of capsules they are required to take each day for the treatment of this devastating disease."

"We are excited about the approval of Namzaric — the first fixed-dose combination of extended-release memantine and donepezil — and look forward to its launch by Actavis in 2015," said Gregory T. Went, Ph.D., Chairman and CEO of Adamas Pharmaceuticals, Inc.  "Namzaric is also the first FDA-approved FDC product to emerge from Adamas' platform for modifying the pharmacokinetic profiles of approved drugs, and we look forward to developing additional new treatments for individuals with serious neurological CNS disorders."

Namzaric, formerly known as MDX-8704, is a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) and donepezil 10 mg. In addition, the capsules can be opened to allow the contents to be sprinkled on food to facilitate dosing for patients who may have difficulty swallowing.

"When determining therapies for my patients in the moderate to severe stages of Alzheimer's disease, I consider the therapy's effectiveness, safety profile and its ease of administration. The FDA's approval of Namzaric offers a new therapeutic option that provides patients a fixed-dose combination of two treatments often prescribed together, in one capsule," said Gustavo Alva, MD, Neuropsychiatrist and Medical Director at ATP Clinical Research in Costa Mesa, CA and volunteer faculty member at University of California, Irvine.

Namzaric will be available in two dosage strengths, 28/10 mg (memantine extended release/donepezil) and 14/10mg (memantine extended release/donepezil) for patients with severe renal impairment. Memantine ER 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®, 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. Actavis expects to launch Namzaric in the U.S. in the second quarter of 2015.

About the Clinical Trials
The efficacy and safety of the coadministration of memantine HCl extended release and acetylcholinesterase inhibitors (AChEIs), including donepezil HCl, was based on the results of a randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of AChEIs. The clinical study was not conducted with Namazaric; however, bioequivalence of Namazaric with coadministered memantine HCl extended release and donepezil HCl was demonstrated. Approximately 68% of the patients randomized to receive either memantine HCl extended release 28 mg or placebo were taking donepezil as the AchEI at Baseline and throughout the study. The results of this study, demonstrated statistically significant improvement in cognition and global function for patients treated with NAMENDA XR 28 mg plus an AChEI compared to placebo plus an AChEI.

The most commonly observed adverse reactions seen with memantine hydrochloride extended-release in patients with moderate to severe Alzheimer's disease, defined as those occurring at a frequency of at least 5% in the memantine hydrochloride extended-release group and at a higher frequency than placebo, were headache, diarrhea, and dizziness.

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. is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system.  The company achieves this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone or in fixed-dose combination products.  Adamas is currently developing its lead wholly-owned product candidate, ADS-5102, for a complication 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 developed with Forest.  The first is a fixed-dose combination product, Namzaric, and the second is a controlled-release product, Namenda XR^®.  Forest markets 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 specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world. 

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories.  The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications.  Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis' website at www.actavis.com.

Forward-Looking Statements

Adamas 
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.  Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "look forward," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements.  Such statements contained in this press release include expectations regarding Namzaric's safety and efficacy profile and its launch and commercialization, as well as Adamas' platform and development activities.  For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to the competitive environment, manufacturing on a commercial scale and the effectiveness of the intellectual property portfolio, as well as risks relating to Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 4, 2014. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release.

Actavis
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; 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 September 30, 2014. 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:
Charlie Mayr
(862) 261-8030

David Belian
(862) 261-8141

ADAMAS CONTACT:
Julie Wood 
(510) 450-3528

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/actavis-and-adamas-announce-fda-approval-of-namzaric-a-fixed-dose-combination-of-memantine-extended-release-and-donepezil-hydrochloride-300013883.html

SOURCE Actavis plc

Related Links

http://www.actavis.com