NEW YORK, Feb. 27 /PRNewswire-FirstCall/ -- Forest Laboratories
Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc.
(NYSE: FRX), announced today that it and Mylan Inc. (NYSE: MYL) have
amended their January 2006 agreement to commercialize, develop and
distribute the novel beta blocker Bystolic(TM) (nebivolol), which is
currently approved in the United States for the treatment of hypertension.
The companies have agreed that Forest will assume Mylan's commercial rights
for Bystolic in the United States and Canada including, but not limited to,
the elimination of Mylan's option to co-promote the product. Forest will be
responsible for all future Bystolic development expenses as well as all
sales and marketing expenses for the product.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Under the terms of this amendment, Forest Laboratories Holdings, Ltd.
(Ireland) will make a one-time cash payment of $370 million to Mylan.
Forest will continue to pay Mylan its contractual royalties for three
years, through calendar 2010, after which Forest will pay an amount
consistent with the royalty rates Forest generally pays with respect to its
principal products for the supply of active pharmaceutical ingredient
(API). Beginning in the first quarter of calendar 2011 Forest will amortize
the one-time cash payment over the remaining patent life of the product.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said:
"This amendment provides an opportunity for Forest to significantly reduce
future royalty expenditures for Bystolic resulting in a favorable impact on
the overall economics of Bystolic's commercialization program. We have also
recaptured co-promotion rights to the product, allowing us to retain more
product value in the future. We have been very pleased with our partnership
with Mylan thus far and this is a mutually beneficial proposition for the
companies."
About Bystolic
Bystolic (nebivolol) is a novel beta blocker that was approved by the
FDA in December 2007 and is approved and marketed in more than 65 countries
outside of North America. Mylan licensed the U.S. and Canadian rights to
Bystolic from Janssen Pharmaceutical N.V. in 2001, and obtained Janssen's
consent to sub-license Bystolic to Forest Laboratories in those territories
in an initial agreement completed in January 2006. Bystolic is a
cardio-selective beta-1 blocker, with vasodilation properties and a
favorable tolerability profile. Upon FDA approval, Bystolic has received
five years of marketing exclusivity under the Hatch Waxman legislation. In
addition there is an issued U.S. pharmaceutical composition of matter
patent that expires in 2021, which may offer additional exclusivity.
About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com) is a U.S.-based pharmaceutical
company dedicated to identifying, developing, and delivering products that
make a positive difference in peoples' lives. Forest Laboratories' growing
product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated
for adults for the initial and maintenance treatment of major depressive
disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Campral(R)*
(acamprosate calcium), indicated in combination with psychosocial support
for the maintenance of abstinence from alcohol in patients with alcohol
dependence who are abstinent at treatment initiation; and Bystolic(TM)
(nebivolol), a beta-adrenergic receptor blocking agent indicated for the
treatment of hypertension. In addition to our growing product line, Forest
also co-promotes the Daiichi Sankyo, Inc. products Benicar(R)* (olmesartan
medoxomil), an angiotensin receptor blocker; Benicar HCT(R)* (olmesartan
medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and
diuretic combination product; and AZOR(TM)* (amlodipine and olmesartan
medoxomil), a calcium channel blocker and angiotensin receptor blocker
combination product, all indicated for the treatment of hypertension.
* Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are
registered trademarks of Daiichi Sankyo, Inc.; and Campral is a
registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
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, including with regard to the
future value of the product and the anticipated economic impact of the
transaction. These statements involve a number of risks and uncertainties,
including regulatory matters outside of the companies' control, the
acceptance and demand for Bystolic, the impact of competitive products and
pricing, 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.
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Investors: Charles Triano of Forest
Laboratories, Inc., +1-212-224-6714; Media: Liesel Enke of
Fleishman-Hillard for Forest Laboratories, Inc., +1-212-453-2427
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