Cubist Announces EMA Acceptance of Ceftolozane/Tazobactam Marketing Authorization Application for Review
August 22 2014 - 7:30AM
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.
INVESTORS:Cubist Pharmaceuticals,
Inc.Eileen C. McIntyre, 781-860-8533Vice President, Investor
Relationseileen.mcintyre@cubist.comorMEDIA:U.S. Media:Cubist Pharmaceuticals,
Inc.Jennifer Baird, 781-860-1282Director of Product
Communicationsjennifer.baird@cubist.comorEurope Media:Weber
ShandwickSally Green, +44 (0) 20 7067 0566Account Executive,
Healthsgreen@webershandwick.com