LOUISVILLE, Colo. and NEW YORK, Feb. 23 /PRNewswire-FirstCall/ --
Replidyne, Inc. and Forest Laboratories, Inc. (NYSE: FRX) 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.
SOURCE Forest Laboratories, Inc. and Replidyne, Inc.
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Related links:
http://www.frx.com
http://www.replidyne.com
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
CONTACT:
Charles E. Triano, Vice President-Investor
Relations of Forest Laboratories, Inc., +1-212-224-6714; or Jill
Clark, Senior Director-Finance of Replidyne, Inc.,
+1-303-996-5504
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