PARIS and NEW YORK, Jan. 22 /PRNewswire-FirstCall/ -- Novexel, S.A. and
Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest
Laboratories, Inc. (NYSE: FRX), today announced that they have entered into
an agreement for the development, manufacture and commercialization of
Novexel's novel intravenous beta lactamase inhibitor, NXL 104 in
combination with Forest's ceftaroline. NXL 104 is designed to be
co-administered with select antibiotics to enhance their spectrum of
activity. Under the terms of the license, Forest will receive the exclusive
rights to administer NXL 104 with ceftaroline as a combination product in
North America. Ceftaroline is a novel, bactericidal injectable broad
spectrum cephalosporin being developed as a therapeutic agent for the
treatment of gram-positive pathogens including methicillin resistant
staphylococcus aureus (MRSA), and multi-drug resistant streptococcus
pneumoniae (MDRSP), as well as common gram-negative organisms. Ceftaroline
is being studied as a monotherapy in phase III clinical trials for
complicated skin and skin structure infections and community acquired
pneumonia. Forest intends to initiate Phase I studies of the
ceftaroline/NXL 104 combination in the next fiscal year. Forest will also
receive a first negotiation right in North America to an additional NXL 104
combination with ceftazidime, a cephalosporin antibiotic having a different
spectrum of activity compared to ceftaroline. This combination is currently
being studied in phase I clinical trials conducted by Novexel.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
NXL 104 inhibits bacterial enzymes called beta-lactamases that break
down beta-lactam antibiotics (in particular Penicillins and
Cephalosporins). Beta- lactamase inhibition represents a mechanism for
counteracting resistance and enhancing broad-spectrum activity of
beta-lactam antibiotics. A composition of matter patent which claims NXL
104 would provide protection for the ceftaroline/NXL 104 combination
product until 2022, subject to possible patent term extension.
Under the terms of the agreement, Forest will pay Novexel an upfront
license payment of euro 75 million. Forest will fund development and
commercialization of the ceftaroline/NXL 104 combination. Additional
milestone payments to Novexel if the combination product is successfully
developed could total euro 75 million. Following the product's regulatory
marketing approval, Forest will pay Novexel a low double digit royalty on
product sales throughout North America.
Iain Buchanan, Chief Executive Officer of Novexel said "Novexel is very
pleased to conclude this transaction with Forest Laboratories which will
combine the potent beta lactamase inhibition of NXL 104 with the
antibacterial spectrum of ceftaroline. We look forward to working with our
partner to ensure the successful development of this compelling product. In
addition, the significant funding which Novexel will receive under this
agreement will enable the company to devote the appropriate resources to
the parallel and independent Phase II development of NXL 104 in combination
with ceftazidime.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said,
"We believe this collaboration with Novexel, resulting in combining
ceftaroline with NXL 104, will significantly advance the continuous effort
to protect patients against infectious pathogens. NXL 104 is the latest
development against the most widely used defense that these pathogens
utilize as the basis for their resistance to antibiotics. By increasing the
already significant spectrum of activity of ceftaroline, including MRSA,
with the addition of the beta lactamase inhibitor NXL 104, we will have
achieved the premier, broad- spectrum antibiotic presently available.
We look forward to collaborating with the accomplished scientists at
Novexel in the further development of ceftaroline/NXL 104 and other
advances in the infectious disease area."
About NXL 104
NXL 104 is the first drug candidate in a new class of inhibitors of
beta lactamases. Microbiology studies of NXL 104 in combination with
ceftaroline demonstrated that NXL 104 increases ceftaroline's activity
against beta lactamase producing gram negative pathogens. Data from Phase I
studies of NXL 104 in combination with ceftazidime in healthy subjects
indicated that NXL 104 is well tolerated and safely administered at a
variety of doses.
About Novexel
Novexel is a pharmaceutical company that researches and develops novel
class anti-infectives for the treatment of severe and difficult to treat
bacterial and fungal infections. The company has an extensive portfolio of
antibacterial and anti-fungal compounds, R&D programs and intellectual
property. Novexel's focus is on novel antimicrobial compounds with activity
against multi-resistant organisms. Novexel's expertise in Biology,
Medicinal Chemistry, Pharmacology, Microbiology and Clinical Development
positions the Company at the forefront of the discovery and development of
the novel therapies for infectious disease.
At inception, the Paris-based company took possession of an advanced
portfolio of anti-infective programs and intellectual property formerly the
property of Sanofi-Aventis, and received euro 40 million in financing from
an international group of leading life science investors led by Atlas
Venture and including Sofinnova, 3i, Abingworth and Novo A/S. A second
round of financing was completed in January 2007, raising a total of euro
50 million from lead investor Edmond de Rothschild Investment Partners of
Paris, all investors from the first round, and new investors, Goldman
Sachs, NeoMed and NIF SMBC (Tokyo).
Novexel's assets include five compounds in formal development: the oral
streptogramin anti-bacterial compound, NXL 103 (formerly XRP2868), in Phase
II; NXL 101 (formerly AVE4221), a bacterial topoisomerase inhibitor
targeting gram-positive bacteria, in Phase I; NXL 104 (formerly AVE1330A),
a wide spectrum beta-lactamase inhibitor, in Phase I, the aminocandin
anti-fungal, NXL 201 (formerly HMR3270), currently undergoing reformulation
studies after initiation of Phase I trials, and NXL 105, a novel class
non-beta-lactam inhibitor of penicillin binding proteins (PBP), in
pre-clinical development.
Novexel holds exclusive worldwide development and commercialization
rights on all compounds in its pipeline except for NXL 104 which is now
partnered with Forest in the North American market, and NXL 103 (formerly
XRP2868), on which Sanofi-Aventis holds an option until the end of Phase
IIa.
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 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; 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, and Bystolic(TM)
(nebivolol), a beta-adrenergic receptor blocking agent indicated for the
treatment of hypertension. In addition to our growing product line, Forest
also co-promotes the Daiichi Sankyo, Inc. products Benicar(R)* (olmesartan
medoxomil), an angiotensin receptor blocker, Benicar HCT(R)* (olmesartan
medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and
diuretic combination product, and Azor(TM)* (amlodipine and olmesartan
medoxomil) a calcium channel blocker and angiotensin receptor blocker
combination product, all indicated for the treatment of hypertension.
*Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT
are registered trademarks of Daiichi Sankyo, 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 Litigation Reform act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the 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 form time to time in
the Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q, and any subsequent SEC filings.
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Charles E. Triano, Vice President - Investor
Relations of Forest Laboratories, Inc., +1-212-224-6714,
Charles.Triano@frx.com
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