Forest Laboratories and Adamas Pharmaceuticals Enter into Licensing Agreement for the Development and Commercialization of a

  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

Business Wire

NEW YORK & EMERYVILLE, Calif. -- November 14, 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 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 Nurelin^TM, our late-stage product candidate for the treatment
of CNS disorders, includingParkinson'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.

Contact:

Forest Laboratories, Inc.
Frank J. Murdolo, 212 224-6714
Vice President – Investor Relations
media.relations@frx.com
or
Adamas Pharmaceuticals, Inc.
Kim Kraemer, 510 450-3572
Corporate Communications
press@adamaspharma.com
 
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