NEW YORK, May 1 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that its licensing partner Mylan Laboratories
(NYSE: MYL) submitted a response to the approvable letter issued by the
United States Food and Drug Administration (FDA) for the compound
nebivolol, a selective beta 1- blocker with vasodilating properties
currently under U.S. regulatory review for the treatment of hypertension.
Upon acceptance of this response, Forest anticipates the FDA will complete
its review of nebivolol's new drug application within six months.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
"We believe the supplemental data will provide the FDA with the
information they have requested. Nebivolol has already received an
approvable letter and we are confident that it should soon be approved. We
expect that nebivolol will provide an important new option for physicians
in the management of hypertension," said Howard Solomon, Chairman and Chief
Executive Officer, Forest Laboratories. "We are excited about the
opportunity to market nebivolol and look forward to a long-term
collaboration with Mylan."
Forest licensed nebivolol from Mylan Laboratories in January 2006 and
has responsibility for all sales and marketing as well as the current and
future development programs. Mylan has retained an option to co-promote the
product in the future.(1)
"In partnership with Forest Laboratories, we have secured the data
required by the FDA in the approvable letter for nebivolol," said Robert J.
Coury, Vice Chairman and Chief Executive Officer of Mylan Laboratories. "We
continue to be committed to providing the necessary support for nebivolol
to gain approval in the U.S."
Nebivolol is a selective beta 1-adrenergic (cardioselective) receptor
antagonist with vasodilating properties(2) and is already approved and
successfully marketed for the treatment of hypertension in more than 50
countries outside of North America.(3)
About Forest Laboratories and Its Products
Forest Laboratories is a US-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; Benicar(R)* (olmesartan medoxomil),
an angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil-
hydrochlorothiazide), an angiotensin receptor blocker and diuretic
combination product, each indicated for the treatment of hypertension; and
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.
* Benicar is a registered trademark of Daiichi Sankyo, Inc., and
Campral is a registered trademark of Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany.
About Mylan Laboratories
Mylan Laboratories Inc. is a leading pharmaceutical company with three
principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc.
and UDL Laboratories Inc., and a controlling interest in Matrix
Laboratories Limited, India. Mylan develops, licenses, manufactures,
markets and distributes an extensive line of generic and proprietary
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
the Forest Laboratories' SEC reports, including the Company's Annual Report
on Form 10-K for the fiscal year ended March 31, 2006 and on Form 10-Q for
the periods ended June 30, 2006, September 30, 2006 and December 31, 2006.
(1) Mylan Laboratories and Forest Laboratories joint press release,
January 11, 2006: "Mylan Laboratories and Forest Laboratories Announce
Nebivolol Licensing Agreement."
(2) Tzemos, N. "Nebivolol Reverses Endothelial Dysfunction in Essential
Hypertension: A Randomized, Double-Blind, Crossover Study." Circ. 2001;
(3) Mylan Press Release, June 1, 2005: "Mylan Laboratories Receives
Approvable Letter For Its Next Generation Beta-Blocker Nebivolol."
SOURCE Forest Laboratories, Inc.