LEXINGTON, Mass. -- (Business Wire)
Cubist
Pharmaceuticals, Inc. (NASDAQ:CBST) today announced that the
European Medicines Agency (EMA) has accepted for review the Company’s
Marketing Authorization Application (MAA) for its investigational
antibiotic ceftolozane/tazobactam. Cubist is seeking approval of
ceftolozane/tazobactam for the treatment of complicated urinary tract
Infections and complicated intra-abdominal infections, with a decision
from the European Commission (EC) expected during the second half of
2015.
The MAA submission is based on positive data from two pivotal Phase 3
clinical trials of ceftolozane/tazobactam in complicated urinary tract
infections and complicated intra-abdominal infections. These studies met
both the EMA and U.S. Food and Drug Administration (FDA) specified
primary endpoints. Results of the secondary analyses were consistent
with and supportive of the primary outcomes. In the clinical trials,
ceftolozane/tazobactam demonstrated activity against problematic
Gram-negative bacteria, including Pseudomonas aeruginosa and
extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli
(E. coli) and Klebsiella pneumoniae in patients with
complicated infections.
“We are pleased to receive MAA acceptance for ceftolozane/tazobactam and
look forward to working with the EMA on this important review,” said
Steven Gilman, Ph.D., Executive Vice President of Research and
Development and Chief Scientific Officer of Cubist. “As we continue to
expand globally, this advancement further positions Cubist to respond to
growing health threats and reinforces our commitment to bring new
antibiotics to patients worldwide facing serious infections, including
those caused by Gram-negative bacteria.”
Prior to the EMA acceptance of the MAA, the FDA accepted the Company’s
New Drug Application (NDA) for ceftolozane/tazobactam with Priority
Review and assigned an action date of December 21, 2014.
About Ceftolozane/Tazobactam
Ceftolozane/tazobactam, an antibiotic candidate being developed to treat
certain Gram-negative infections, consists of ceftolozane, a novel
cephalosporin that has demonstrated potent in vitro activity
against Pseudomonas aeruginosa, with tazobactam, a
well-established beta-lactamase inhibitor. The addition of tazobactam
broadens coverage to include most extended-spectrum beta-lactamase
(ESBL)-producing Escherichia coli (E. coli), Klebsiella
pneumoniae, and other Enterobacteriaceae. Ceftolozane/tazobactam is
under review by the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA) for the potential treatment of
complicated urinary tract infections (cUTI) and complicated
intra-abdominal infections (cIAI). Ceftolozane/tazobactam is also being
developed for the potential treatment of hospital-acquired bacterial
pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
About Gram-negative Bacteria
There has been a worldwide increase in the number of infections caused
by Gram-negative bacteria. Highly adaptive pathogens that can develop
resistance through several mechanisms, resistant Gram-negative bacteria
are a serious global public health concern. Collectively, Escherichia
coli(E. coli), Klebsiella pneumoniae (K. pneumoniae) and Pseudomonas
aeruginosa (P. aeruginosa) account for 27% of all pathogens and 70%
of all Gram-negative pathogens causing healthcare-associated infections
(HAIs). Gram-negative bacteria are common causes of intra-abdominal
infections (IAIs), urinary tract infections (UTIs), and nosocomial, or
hospital-acquired, pneumonia, as well as bacteremia (bloodstream
infections). E. coli is the most common cause of UTIs, and cases
of UTI caused by extended-spectrum beta-lactamase (ESBL)-producing E.
coli and K. pneumoniae, as well as P. aeruginosa,
including drug-resistant strains, are increasing. ESBL-producing E.
coli and K. pneumoniae are also frequently isolated in
patients with complicated IAIs (cIAIs). Additionally, P. aeruginosa
is the most common Gram-negative organism causing ventilator associated
pneumonia and the second most common cause of catheter-associated UTIs.
For more information reference a
video on Gram-negative bacteria mechanisms of resistance.
About Cubist’s Commitment to Antibiotic R&D
Cubist has a growing commitment to global public health through its
leadership in the discovery, development, and commercialization of novel
antibiotics to treat serious and potentially life-threatening infections
caused by a broad range of increasingly drug-resistant bacteria. The
Company hopes to deliver at least four new antibiotics in support of the
Infectious Diseases Society of America (IDSA) goal of 10 new antibiotics
by 2020. Cubist expects to invest approximately $400M USD in 2014 on
antibacterial R&D and approximately 75% of its employee base is focused
on the research, development, commercialization, and support of
antibiotics.
About Cubist
Cubist Pharmaceuticals, Inc. is a global biopharmaceutical company
focused on the research, development, and commercialization of
pharmaceutical products that address significant unmet medical needs in
the acute care environment. Cubist is headquartered in Lexington,
Massachusetts, with a central international office located in Zurich,
Switzerland. Additional information can be found at Cubist’s web site at www.cubist.com.
Also, connect with Cubist on Twitter @cubistbiopharma
and @cubistcareers,
LinkedIn,
or YouTube.
Forward Looking Statements
This press release contains forward-looking statements. Any statements
contained herein which do not describe historical facts, including but
not limited to, statements regarding: the expected timing for a decision
from the EC on our MAA for ceftolozane/tazobactam; positive results from
our Phase 3 clinical trials of ceftolozane/tazobactam; working with the
EMA on the review of the MAA for ceftolozane/tazobactam; our global
expansion, including our commitment to bring new antibiotics to patients
worldwide facing serious infections; the anticipated PDUFA action date
for our NDA with the FDA for ceftolozane/tazobactam; the therapeutic
potential of ceftolozane/tazobactam; our aspirations to achieve a
portion of the IDSA goal of 10 new antibiotics by 2020; and the level of
our financial and personnel commitments towards antibiotic research,
development and commercialization, are forward-looking statements which
involve risks and uncertainties that could cause actual results to
differ materially from those discussed in such forward-looking
statements. Such risks and uncertainties include, among others:
regulatory developments in Europe and the U.S., including the risk that
the EC and/or FDA may not approve on a timely basis or at all, our
marketing applications for ceftolozane/tazobactam, may not agree with
our interpretation of the results from the clinical studies of
ceftolozane/tazobactam, or may require additional data, analysis,
information or further studies that may not be clinically feasible or
financially practicable; the review of our MAA and/or NDA may take
longer than anticipated, including as a result of internal regulatory
authority constraints; any marketing approval for ceftolozane/tazobactam
may impose significant limitations on its use and additional
post-marketing requirements; our ability to obtain adequate pricing and
reimbursement levels for ceftolozane/tazobactam; our ability to
successfully commercialize ceftolozane/tazobactam, including as a result
of regulatory authorities’ decisions regarding labeling and other
matters, including adverse side effects, that could affect its
availability or commercial potential; our ability to acquire, maintain
and enforce intellectual property for ceftolozane/tazobactam;
competitive risks from current and future therapeutic alternatives to
ceftolozane/tazobactam; additional clinical trials of
ceftolozane/tazobactam, including in HABP/VABP, may not be successful or
initiated or conducted in a timely manner; technical difficulties or
excessive costs relating to the manufacture or supply of
ceftolozane/tazobactam, including our ability to work with our third
party contract manufacturers that manufacture and supply
ceftolozane/tazobactam on our behalf; our ability to work with, and the
performance of our third party contract research organizations that help
us conduct our clinical trials; we may encounter other unanticipated or
unexpected risks with respect to the development or manufacture of
ceftolozane/tazobactam; and those additional factors discussed in our
most recent annual report on Form 10-K and subsequent quarterly reports
on Form 10-Q filed with the Securities and Exchange Commission. We
caution investors not to place considerable reliance on the
forward-looking statements contained in this press release. These
forward-looking statements speak only as of the date of this press
release, and we undertake no obligation to update or revise any of these
statements.
Contacts:
INVESTORS:
Cubist Pharmaceuticals, Inc.
Eileen
C. McIntyre, 781-860-8533
Vice President, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
U.S.
Media:
Cubist Pharmaceuticals, Inc.
Jennifer Baird,
781-860-1282
Director of Product Communications
jennifer.baird@cubist.com
or
Europe
Media:
Weber Shandwick
Sally Green, +44 (0) 20 7067 0566
Account
Executive, Health
sgreen@webershandwick.com
Source: Cubist Pharmaceuticals, Inc.
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