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Cerexa to be Acquired by Forest Laboratories for $480 Million
Plus Potential $100 Million Milestone Payment
ALAMEDA‚ Calif.‚ December 14‚ 2006 – Cerexa Inc. today announced
it has entered into a definitive agreement to be acquired by
Forest Laboratories Inc. (NYSE: FRX) for $480 million plus a
potential $100 million milestone payment.
Pursuant to the acquisition, Forest will obtain development and
marketing rights worldwide excluding Japan to Ceftaroline, a
novel antibiotic that will enter Phase 3 clinical trials early
next year, and ME1036, an antibiotic in preclinical development.
In addition, Forest will obtain an option to a third early-stage
antibiotic. The cash-for-stock transaction is expected to close
in Forest’s fiscal fourth quarter following the expiration of
the Hart-Scott-Rodino antitrust waiting period.
"We are delighted to be entering into this transaction with
Forest, which will assume responsibility for the development and
future commercialization of Ceftaroline,” said Dennis Podlesak,
Cerexa’s chief executive officer. “Forest has a proven track
record of success in developing and commercializing products, as
evidenced by the success of the Lexapro®/Celexa® franchise, and
we have great confidence in the company’s ability to optimize
the therapeutic and commercial potential of the Cerexa
portfolio.”
Eckard Weber M.D., Cerexa’s chairman and a partner with Domain
Associates, added: “Ceftaroline is a very promising drug
candidate that we believe will meet a significant unmet need in
the treatment of serious bacterial infections. The company’s
management team has done an outstanding job advancing
Ceftaroline into Phase 3, acquiring additional products and
building Cerexa into a great company. This exceptional portfolio
will be in great hands with Forest.”
In addition to Domain Associates, Cerexa’s investors are Canaan
Partners, Orbimed Advisors, Frazier Healthcare Ventures, New
Leaf Venture Partners, Pappas Ventures, Montreux Equity
Partners, EGS Healthcare Capital Partners and Sears Capital
Management.
"Ceftaroline is an important late-stage development product that
can address serious and life-threatening infections in the
hospital setting including MRSA,” said Howard Solomon, chairman
and chief executive officer of Forest. “This is a significant
medical benefit given the increasing prevalence of MRSA, which
commonly causes severe ‘staph’ infections such as skin
infections that are resistant to treatment with most
antibiotics, and the current limitations of presently available
treatment options. We have a high degree of confidence in the
successful commercialization and financial prospects for
Ceftaroline given the strength of the existing clinical data and
the clinical need for a next generation hospital-based
antibiotic.”
About Ceftaroline
Ceftaroline acetate is a member of the cephalosporin class of
antibiotics, the most frequently prescribed class of antibiotics
in the world. In preclinical studies and clinical trials to
date, Ceftaroline demonstrated a favorable safety profile,
similar to that of existing cephalosporins. Unlike marketed
cephalosporins, Ceftaroline exhibits bactericidal activity
against the most resistant strains of Gram-positive bacteria,
including MRSA. Ceftaroline has also demonstrated bactericidal
activity against penicillin-resistant Streptococcus pneumoniae
and common Gram- negative bacteria. Cerexa licensed from Takeda
Pharmaceutical Company Ltd. the exclusive right to develop and
commercialize Ceftaroline in all countries worldwide except
Japan.
In a Phase 2 randomized, observer-blinded, multi-center trial of
99 treated patients with local and systemic signs of cSSSI
randomized in a 2:1 ratio to receive Ceftaroline or a vancomycin-based
regimen, the clinical cure rate in the clinically evaluable
population was 96.7% for patients treated with Ceftaroline and
88.9% for those treated with the gold-standard comparator
regimen of vancomycin, with or without adjunctive aztreonam. The
microbiological response rate in the microbiologically evaluable
population was 95.2% for the Ceftaroline group and 85.7% for the
standard therapy group. Ceftaroline also demonstrated excellent
in vitro activity against Gram-positive and Gram-negative
organisms isolated from patients in the study, including 100% of
methicillin-resistant Staphylococcus aureus (MRSA) isolates
inhibited at 0.5 mg/L or less.
In the Phase 2 trial, no drug-related serious adverse events
were observed for Ceftaroline. In both the Phase 2 trial and
earlier Phase 1 trials, Ceftaroline displayed a favorable
adverse event profile consistent with the established safety
profile of the cephalosporin class, with the vast majority of
side effects being mild in nature.
About ME1036
ME1036 is a broad-spectrum parenteral carbapenem that has
demonstrated excellent preclinical activity against both aerobic
and anaerobic gram-positive and gram-negative bacteria,
including common drug-resistant pathogens. Unlike carbapenems
that are available today, ME1036 is highly active against
methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-intermediate
Staphylococcus aureus (VISA) and vancomycin-resistant
Enterococcus faecalis (VRE). Cerexa licensed the global
development and commercialization rights to ME1036 from Meiji
Seika Kaisha Ltd.
About Forest Laboratories and Its Products
Forest Laboratories (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® (escitalopram
oxalate), an SSRI indicated for adults for the internal and
maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda® (memantine HCl), an
N-methyl D-aspartate (NMDA)-receptor antagonist indicated for
the treatment of moderate to severe Alzheimer’s disease; Benicar®*
(olmesartan medoxomil), an angiotensin receptor blocker, and
Benicar* HCT® (olmesartan medoxomil-hydrochlorothiazide), an
angiotensin receptor blocker and diuretic combination product,
each indicated for the treatment of hypertension; and Campral®*
(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.
*Benicar is a registered trademark of Daiichi Sankyo Inc., and
Campral is a registered trademark of Merck Sante s.a.s.,
subsidiary of Merck KGaA, Darmstadt, Germany.
About Cerexa
Cerexa Inc. is an innovation-driven biopharmaceutical company
focused on discovering, developing and commercializing a growing
portfolio of novel anti-infective therapies for the treatment of
serious, antibiotic-resistant infections. For more information,
visit
www.cerexa.com.
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