LOUISVILLE, Colo. and NEW YORK, Feb. 23 /PRNewswire-FirstCall/ -- Replidyne, Inc. and Forest Laboratories, Inc. announced today that the New Drug Application (NDA) for faropenem medoxomil has been accepted for standard review by the U.S. Food and Drug Administration (FDA).
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO)
The NDA for faropenem medoxomil was filed on December 20, 2005 for the treatment of acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections in adults. The NDA is based on the results of 11 Phase III efficacy studies in these indications and a safety database of more than 5,000 patients treated with the product. Replidyne and Forest are coordinating additional studies including studies in support of pediatric indications.
About faropenem medoxomil
Faropenem medoxomil is an ester prodrug derivative of the beta-lactam antibiotic faropenem. The prodrug form of faropenem offers dramatically improved oral bioavailability and leads to higher systemic concentrations of the drug. Faropenem medoxomil is a broad-spectrum antibiotic that is highly resistant to beta-lactamase degradation.
About Replidyne
Replidyne, Inc., is a biopharmaceutical company focused on developing and commercializing innovative anti-infective products. Replidyne’s current development programs include higher dose/shorter course therapy, additional indications for adults, and a pediatric formulation of faropenem medoxomil. Replidyne’s pipeline also includes a topical antibiotic, REP8839, which has a novel mechanism of action for addressing the major challenge of methicillin- resistant Staphylococcus aureus (MRSA). Replidyne also has discovery programs directed to the inhibition of bacterial DNA replication, which could result in therapies to treat a wide range of antibiotic-resistant bacteria. For additional information about Replidyne, Inc., please visit: http://www.replidyne.com.
About Forest Laboratories Inc. and Its Products:
Forest Laboratories’ (http://www.frx.com) growing line of products includes: Lexapro(R) (escitalopram oxalate), a selective serotonin reuptake inhibitor (SSRI) antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; 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 indicated for the treatment of hypertension; Benicar* HCT(R) (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second- line treatment of hypertension; Campral (R) * (acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox (TM) (oxycodone HCl and ibuprofen), an opioid and non-steroid anti-inflammatory drug (NSAID) combination indicated for the short-term management of acute, moderate to severe pain.
*Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is a registered trademark under license from 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. Because these statements involve a number of risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, challenges relating to intellectual property protection, 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 Forest Laboratories’ SEC reports, including its Annual Reports on Form 10-K for the fiscal year ended March 31, 2005 and Quarterly Reports on Form 10-Q for the periods ended June 30, 2005, September 30, 2005 and December 31, 2005.
Photo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGOForest Laboratories, Inc. and Replidyne, Inc.
CONTACT: Charles E. Triano, Vice President-Investor Relations of ForestLaboratories, Inc., +1-212-224-6714; or Jill Clark, Senior Director-Financeof Replidyne, Inc., +1-303-996-5504
