NEW YORK, March 10, 2009 /PRNewswire-FirstCall/ -- Forest Laboratories,
Inc. (NYSE: FRX) Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co.
KGaA, and Merz Pharmaceuticals GmbH announced today that the U.S. Patent and
Trademark Office has issued a Notice of Final Determination granting the full
five years of patent term extension for U.S. Patent No. 5,061,703 (the '703
Patent), which is listed in the U.S. Food and Drug Administration Orange Book
for NAMENDA(R) (memantine hydrochloride). Forest has an exclusive license to
the '703 patent from the German pharmaceutical company Merz Pharma. Forest
and Merz have commenced patent litigation against several generic
manufacturers who have filed ANDAs seeking FDA approval to market generic
versions of NAMENDA. A trial in this litigation, pending in the U. S.
District Court for the District of Delaware, is scheduled for April 2010.
After review of the regulatory timeline for approval of NAMENDA(R) the U.S.
Patent and Trademark Office determined that the '703 Patent is entitled to the
full five years of patent term extension and will expire on April 11, 2015
instead of as originally anticipated on September 13, 2013.
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About Merz
Merz Pharmaceuticals researches, develops, produces and distributes
innovative pharmaceutical products in the areas of neurology and psychiatry as
well as in aesthetic dermatology and metabolism. In the area of Alzheimer's
research, Merz Pharmaceuticals has achieved a leading position with the first
active ingredient worldwide for the treatment of moderate to severe
Alzheimer's disease. The company is headquartered in Frankfurt am Main,
Germany. To learn more about Merz, visit www.merz.com.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company
with a long track record of building partnerships and developing and marketing
products that make a positive difference in people's lives. In addition to its
well-established franchises in therapeutic areas of the central nervous and
cardiovascular systems, Forest's current pipeline includes product candidates
in all stages of development and across a wide range of therapeutic areas. The
company is headquartered in New York, NY. To learn more about Forest
Laboratories, 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 Report on Form 10-Q, and
any subsequent SEC filings.
SOURCE Forest Laboratories, Inc.
CONTACT:
Frank J. Murdolo, Vice President - Investor Relations,
Forest
Laboratories, Inc., +1-212-224-6714,
Frank.Murdolo@frx.com
(FRX)