Replidyne and Forest Laboratories Announce Faropenem Medoxomil Licensing Agreement
February 13 2006 - 8:20AM
PR Newswire (US)
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. FCMN Contact: charles.triano@frx.com
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc.; Replidyne, Inc. 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 Web site: http://www.frx.com/
http://www.replidyne.com/
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