Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol
2007年5月2日 - 12:49AM
PRニュース・ワイアー (英語)
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 products. 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; 104:511-514. (3) Mylan
Press Release, June 1, 2005: "Mylan Laboratories Receives
Approvable Letter For Its Next Generation Beta-Blocker Nebivolol."
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Charles E. Triano, Vice
President - Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, or Web site: http://www.frx.com/
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