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.
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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 (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.
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
Web site: http://www.frx.com
(FRX MYL)