NEW YORK, Feb. 6 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and Replidyne, Inc. announced today that they have terminated their collaboration agreement for the development of faropenem medoxomil, a novel oral, community antibiotic.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The agreement was announced in February 2006. In October 2006 the U.S. Food and Drug Administration (FDA) issued a non-approvable letter for four adult indications: acute bacterial sinusitis (ABS), community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and uncomplicated skin and skin structure infections (SSSI). There are no payments by Forest associated with the termination.
Howard Solomon, Chairman and Chief Executive Officer of Forest, stated: "Forest believes the FDA's non-approvable letter clearly raises regulatory uncertainty. We have carefully reviewed all the existing data and the FDA's pronouncements and have determined that we should not continue further development of the faropenem program."
About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com/ ) 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 for 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 Sankyo Pharma, 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 Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, 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 Companies' SEC reports, including the Forest Laboratories, Inc.'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 and September 30, 2006.
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