Novexel and Forest Laboratories Announce License Agreement for NXL 104, a Novel Broad-Spectrum Beta Lactamase Inhibitor
January 22 2008 - 7:30AM
PR Newswire (US)
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.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, Web site:
http://www.frx.com/
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