Forest Laboratories & Adamas Pharmaceuticals Announce Forest’s Submission of New Drug Application for Memantine Extended Re...
March 04 2014 - 8:00AM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX), a leading, fully
integrated, specialty pharmaceutical company largely focused on the
United States market, and Adamas Pharmaceuticals Inc., a privately
held specialty pharmaceutical company, announced Forest’s
submission of a New Drug Application (NDA) to the Food and Drug
Administration for a fixed-dose combination (FDC) of memantine HCl
extended release (ER) and donepezil HCl for the treatment of
moderate to severe dementia of the Alzheimer’s type.
“The concurrent use of memantine and donepezil is a
well-established treatment option for patients with moderate to
severe dementia related to Alzheimer’s disease. Using the two drugs
together appears to provide benefit over using acetylcholinesterase
inhibitors alone. Reducing the number of pills by offering patients
a fixed-dose combination helps lessen the daily medication burden
and could improve patient adherence and compliance,” said Pierre
Tariot, MD, at the Banner Alzheimer’s Institute, who has also
consulted to both Adamas and Forest.
The memantine ER-donepezil HCl FDC 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
applesauce to facilitate dosing for patients who may have
difficulty swallowing.
The New Drug Application consisted of two dosage strengths,
28mg/10mg (memantine extended release/donepezil) and 14mg/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. Forest and Adamas collaborated on the development of the
fixed dose combination and Forest will have exclusive US
commercialization rights while Adamas will retain exclusive
commercialization rights outside of the US. The FDC product is
covered by multiple Adamas patents and a Forest patent that extend
to 2029.
About Alzheimer’s disease
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 is driven to improve the lives of those
affected by chronic central nervous system (CNS) disorders by
enhancing the pharmacokinetic profiles of approved drugs to create
novel treatments for use alone and in fixed-dose combination
products. The Company is currently advancing a pipeline of
aminoadamantane-based drug candidates for the treatment of a
complication of Parkinson’s disease, chronic behavioral symptoms
associated with traumatic brain injury and dementia associated with
Alzheimer’s disease. The Phase 2/3 EASED study investigating
ADS-5102 (amantadine HCl ER) for the treatment of levodopa-induced
dyskinesia in Parkinson’s disease has been completed and met its
primary endpoint. MDX-8704 (memantine HCl ER/donepezil) is a
fixed-dose combination product candidate in late-stage
investigation for the treatment of dementia associated with
Alzheimer’s disease. In November 2012, Adamas entered into an
agreement with Forest Laboratories, Inc. for the development and
commercialization of MDX-8704 in the United States. Adamas plans to
advance its product candidates through approval and to
commercialize approved products in the United States through a
specialty CNS sales force. For more information about Adamas,
please visit www.adamaspharma.com.
About Forest Laboratories and Its Products
Forest Laboratories (NYSE:FRX) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. The Company markets a portfolio of branded drug
products and develops new medicines to treat patients suffering
from diseases principally in the following therapeutic areas:
central nervous system, cardiovascular, gastrointestinal,
respiratory, anti-infective, and cystic fibrosis. Our strategy of
acquiring product rights for development and commercialization
through licensing, collaborative partnerships, and targeted mergers
and acquisitions allows us to take advantage of attractive
late-stage development and commercial opportunities, thereby
managing the risks inherent in drug development. The Company is
headquartered in New York, NY. To learn more, visit
www.FRX.com.
Except for the historical information contained herein, this
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories’ Annual Report on Form 10-K, Quarterly Reports on Form
10-Q and any subsequent SEC filings. Forest assumes no obligation
to update forward-looking statements contained in this release to
reflect new information or future events or developments.
ARICEPT® is a trademark used by Eisai Inc. under license from
Eisai R&D Management Co., Ltd.
NAMENDA XR® is a registered trademark of Merz GmbH KGaA
For Forest LaboratoriesFrank J. Murdolo, 212-224-6714Vice
President - Investor Relationsmedia.relations@frx.comorAmanda
KaufmanMedia Relationsamanda.kaufman@frx.comorFor
AdamasGregory T. Went, 510-450-3502Chief Executive
Officergwent@adamaspharma.com
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