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Forest Laboratories and Adamas Pharmaceuticals Enter into Licensing Agreement for the Development and Commercialization
of a Fixed Dosed Combination of Namenda XR® and Donepezil for Alzheimer’s Disease
NEW YORK & EMERYVILLE, CA, November 13, 2012 - 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
US 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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