FDA Advisory Committee Recommends Approval of Forest Laboratories’ Ceftaroline Fosamil for the Treatment of Community Acqui...
September 07 2010 - 4:55PM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) announced that the U.S.
Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory
Committee voted 21 – 0 in favor of approval of ceftaroline fosamil
for the treatment of community acquired bacterial pneumonia (CABP)
and voted 18 – 0 in favor of approval for complicated skin and skin
structure infections (cSSSI).
Ceftaroline is a novel, bactericidal, broad-spectrum injectable
cephalosporin shown in pre-clinical and clinical trials to have
activity against both gram-positive pathogens, including
methicillin-resistant Staphylococcus aureus (MRSA) and
Streptococcus pneumoniae, and common gram-negative pathogens.
The committee’s recommendation will be considered by the FDA as
it reviews the new drug application (NDA) for ceftaroline, which
was based primarily on data from two Phase III trials in CABP –
FOCUS I and FOCUS II – and two Phase 3 trials in cSSSI – CANVAS I
and CANVAS II. Forest anticipates action by the FDA during the
fourth calendar quarter.
About Ceftaroline and Ceftaroline / NXL104
Ceftaroline is a novel, bactericidal, injectable, broad-spectrum
cephalosporin being developed as a therapeutic agent for the
treatment of cSSSI and CAP, which include resistant gram-positive
pathogens such as methicillin-resistant Staphylococcus aureus
(MRSA) and S. pneumoniae (as well as common gram-negative
organisms). Ceftaroline has demonstrated antibacterial activity in
vitro against vancomycin-resistant S. aureus (VRSA) and
linezolid-resistant S. aureus. Ceftaroline is a member of the
cephalosporin class of antibiotics, the most frequently prescribed
class of antibiotics in the world. In clinical trials, ceftaroline
has been generally well tolerated with an adverse event profile
consistent with the cephalosporin class of antibiotics. Forest
obtained the worldwide rights (excluding Japan, where Takeda
Pharmaceuticals holds rights) to ceftaroline in 2007 when it
acquired Cerexa, Inc., a privately held biopharmaceutical company.
In August 2009, Forest Laboratories and AstraZeneca (NYSE:AZN)
entered into a definitive collaboration agreement to co-develop and
commercialize ceftaroline in all markets outside the U.S., Canada
and Japan.
Forest is also developing a combination product consisting of
ceftaroline and NXL104, a novel beta-lactamase inhibitor. The
combination of NXL104 with ceftaroline enhances the in vitro
antibacterial activity of ceftaroline against extended-spectrum
beta-lactamase-producing (ESBL) gram-negative bacteria that are
normally resistant to currently available broad-spectrum
cephalosporins.
About CABP Requiring Hospitalization
In 2006, pneumonia, along with influenza, was the eighth leading
cause of death in the U.S. and the number one cause of death in
those over age 65. The cost of care for patients with CABP in the
U.S. has been estimated to be over $10 billion annually.
The primary treatment for CABP is antibiotics, and the rates of
resistance to many commonly used antibiotics are increasing. S.
pneumoniae accounts for 60 to 70 percent of all bacterial CABP
cases and data have shown that, overall, pneumococcal strains had a
28 percent intermediate resistance rate and a 16 percent high-level
resistance rate. With increasing rates of pneumonia caused by MRSA
and the high rates of resistance to common antibiotics, treatment
options are becoming more limited.
About cSSSI
cSSSIs are caused by gram-positive bacteria, such as MRSA, and
common gram-negative bacteria. cSSSIs are among the most common
infections treated in the hospital setting and MRSA infections are
becoming more common in patients in both the hospital and community
settings, now the most frequent cause of cSSSI presenting to
emergency departments in the United States and the cause of over
18,000 deaths in 2005.
According to the Centers for Disease Control and Prevention,
about 70 percent of bacterial infections are resistant to at least
one drug. Many are resistant to multiple drugs making cSSSIs,
especially due to MRSA, challenging to treat. cSSSIs can become
extremely serious, leading to hospitalization, an increased risk
for morbidity and mortality and increased healthcare costs.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical
company with a long track record of building partnerships and
developing and marketing products that make a positive difference
in people’s lives. In addition to its well-established franchises
in therapeutic areas of the central nervous and cardiovascular
systems, Forest’s current pipeline includes product candidates in
all stages of development and across a wide range of therapeutic
areas. The Company is headquartered in New York. To learn more
about Forest Laboratories, visit www.FRX.com.
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 from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
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