Forest Laboratories & Adamas Pharmaceuticals Enter into Licensing Agreement for the Development & Commercialization of a Fixe...
November 14 2012 - 8:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX), an international
pharmaceutical company, and Adamas Pharmaceuticals, Inc. announced
today that they have entered into an agreement for the development
and commercialization of a fixed dosed combination (FDC) of Namenda
XR® (memantine HCl extended release) and donepezil HCl as a once
daily therapy for the treatment of moderate to severe dementia of
the Alzheimer’s type in the United States. Under the agreement,
Forest and Adamas will collaborate on the development of the FDC
and Forest will have exclusive US commercialization rights. Forest
is responsible for all development and commercialization
activities. Namenda XR® is Forest’s FDA approved, once daily
formulation of its successful Alzheimer’s therapy Namenda®. Based
on a development plan agreed to by Adamas and the FDA, the FDC is
expected to launch in 2015 following FDA approval. The product will
be covered by multiple Adamas patents that extend to 2029. Forest
sells Namenda in the U.S. under a 2000 license from Merz & Co.
GmbH & Co.
Pursuant to the agreement, Forest will pay Adamas $65 million
upfront and up to $95 million in future development and FDA
approval milestones. Adamas will receive royalties on US net sales
beginning 5 years after launch for FDC products and any additional
memantine products for which Adamas’ patents are listed in the
FDA’s Orange Book.
“We are pleased to enter into this partnership with Adamas,
which will enable us to enhance our life cycle program for
Namenda,” said Howard Solomon, Chairman, Chief Executive Officer
and President of Forest. “Adamas has made impressive progress with
its combination extended release memantine and donepezil program.
Forest is the ideal company to complete the development of this
product and commercialize it in the US, in light of our successful
track record in the field of Alzheimer’s disease with Namenda. Over
60% of Namenda patients already take Namenda together with an
acetylcholinesterase inhibitor like donepezil, which creates a
substantial market opportunity for this fixed dose combination
product. Namenda and donepezil work in different ways and studies
support that when used together they improve cognition, function,
and behavior in some patients with moderate to severe Alzheimer’s
disease. This new fixed combination, which reduces the pill
requirement from three tablets to one and the dosing frequency from
two times per day to once per day, can benefit physicians,
caregivers, and patients.”
Gregory T. Went, Chief Executive Officer of Adamas
Pharmaceuticals said: “We are pleased to partner with Forest, the
market leader in Alzheimer's products, to bring our fixed dose
combination of extended release memantine and donepezil – the first
such combination therapy for Alzheimer's disease – to the US
market. This collaboration will accelerate this innovative
product’s development towards a 2014 US NDA filing, and allow
Adamas to focus our attention on the ex-US market for the product
and to continue the ongoing development of NurelinTM, our
late-stage product candidate for the treatment of CNS disorders,
including Parkinson's disease.”
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, based in Emeryville, California with
operations in Bangalore, India, is the leading developer of
aminoadamantane-based therapeutics for CNS disorders. The company’s
research and development platform is focused on developing
controlled release versions and optimized fixed dose combinations
of aminoadamantanes to address major dosing and titration
challenges that limit the use of currently available therapeutics.
Adamas is advancing two programs from this platform. Nurelin
(amantadine HCl extended release capsules) is currently in Phase 3
clinical studies, initially for levodopa-induced dyskinesia in
patients with Parkinson’s disease. A registration program is also
underway for the fixed dose combination of memantine HCl extended
release and donepezil HCl for Alzheimer’s disease. Both products
are designed to improve tolerability and clinical efficacy, and to
provide superior clinical and health economic benefits. For more
information about Adamas, please visit www.adamaspharma.com.
About Forest Laboratories
Forest Laboratories’ (NYSE: FRX) longstanding global
partnerships and track record developing and marketing
pharmaceutical products in the United States have yielded its
well-established central nervous system and cardiovascular
franchises and innovations in anti-infective, respiratory,
gastrointestinal, and pain management medicine. Forest’s pipeline,
the most robust in its history, includes product candidates in all
stages of development across a wide range of therapeutic areas.
Forest 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 Reports 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.
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