EMERYVILLE, Calif.,
Jan. 9, 2014 /PRNewswire/
-- Adamas Pharmaceuticals, Inc. announced today that it has
received $40 million in milestone
payments from Forest Laboratories Holdings Limited (NYSE: FRX) for
MDX-8704. MDX-8704 is a fixed dosed combination (FDC) of
Namenda XR® (memantine HCl extended release capsules)
and donepezil HCl being developed as a once daily therapy for the
treatment of moderate-to-severe dementia of the Alzheimer's type in
the United States.
The milestone payments are for the successful completion of
studies that support the planned New Drug Application (NDA) filing
with the US Food and Drug Administration (FDA) for MDX-8704 by
Forest in the first half of 2014. These studies are based on
a development plan agreed to by Adamas and the FDA prior to its
license agreement with Forest. Leveraging Adamas' know-how
and intellectual property, the companies are collaborating on the
development of the FDC, for which Forest has exclusive US
commercialization rights. Forest is responsible for all
regulatory-related activities. MDX-8704 is covered by
multiple Adamas and Forest patents that extend to 2029.
Pursuant to their license agreement for development and
commercialization of MDX-8704, Forest paid Adamas $65 million upfront in November 2012, and these $40 million payments are part of up to
$95 million in subsequent development
and regulatory approval milestones. In addition, under the
terms of the license agreement, Adamas will receive royalties
beginning five years after launch on US net sales of FDC products
and any additional memantine products for which Adamas' patents are
listed in the FDA's Orange Book.
About Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals is dedicated to improving the lives of
those affected by central nervous system (CNS) disorders by
enhancing the pharmacokinetic profiles of approved drugs to create
novel treatments for use alone and as components of fixed-dose
combination products. The Company is currently advancing a
pipeline of aminoadamantane-based drug candidates for the treatment
of Parkinson's disease, Alzheimer's disease, and other CNS
disorders. 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.
SOURCE Adamas Pharmaceuticals, Inc.