LOUISVILLE, Colo. and NEW YORK, Feb. 13 /PRNewswire-FirstCall/ --
Replidyne, Inc., a privately held biopharmaceutical company and Forest
Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories,
Inc. (NYSE: FRX) announced today that the two companies have entered into an
agreement for the commercialization, development and distribution of
Replidyne's new oral antibiotic, faropenem medoxomil, in the United States.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
On December 20, 2005, Replidyne submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for faropenem medoxomil 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.
Under the terms of the agreement, Forest will make a $50 million upfront
payment to Replidyne as well as potential future milestone payments. In
addition, Replidyne will receive royalty payments based on faropenem medoxomil
sales. Forest and Replidyne will jointly oversee the development and
regulatory approval of faropenem medoxomil and share all expenses for current
and future development programs. Forest will be primarily responsible for
sales and marketing of faropenem medoxomil and Replidyne intends to market the
product to infectious disease specialists and otolaryngologists. Replidyne
also has an option to market and promote the product to pediatricians upon FDA
approval of a pediatric formulation.
"Forest has a proven track record of launching branded products in the
primary care market, and they will be an ideal partner," said Kenneth Collins,
President and Chief Executive Officer of Replidyne. "Forest has consistently
demonstrated the commitment and knowledge necessary for a successful product
launch. The Replidyne team looks forward to working with Forest on co-
promotion and continued development of faropenem medoxomil to maximize its
significant market potential."
Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "We
are very pleased to have entered into this agreement with Replidyne for
faropenem medoxomil. Antibiotics are a new and we believe important area for
Forest to add to our CNS and cardiovascular franchises. Upon FDA approval,
faropenem medoxomil will be the first orally available penem in the U.S.
Faropenem medoxomil also has other desirable features which we expect will
enable it to achieve a significant position in the armamentarium of
antibiotics prescribed by physicians. We are also especially delighted to be
entering into this partnership with Replidyne, whose principals have expertise
in the development and marketing of antibiotics, which will be immensely
useful in establishing faropenem medoxomil."
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. The NDA submitted to the FDA in
December 2005 is subject to FDA acceptance.
Replidyne licensed exclusive rights to faropenem medoxomil in March 2004
from Daiichi Asubio Pharma Co., Ltd. for the U.S. and Canada and an exclusive
option to the rest of the world, except Japan. The product was known at that
time as faropenem daloxate. In addition to five years of Hatch-Waxman
exclusivity granted upon approval, faropenem medoxomil is protected by an
issued U.S. composition of matter patent expiring in 2015. Extension of
exclusivity under Hatch-Waxman legislation is expected.
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.; 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., 212-224-6714, or Jill
Clark, Senior Director-Finance, Replidyne, Inc., 303-996-5504
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