Cubist Announces Acceptance of Ceftolozane/Tazobactam New Drug Application with Priority Review
June 19 2014 - 3:30PM
Business Wire
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that
the U.S. Food and Drug Administration (FDA) has accepted the
Company’s New Drug Application (NDA) for its investigational
antibiotic ceftolozane/tazobactam with Priority Review. The FDA has
assigned a Prescription Drug User Fee Act (PDUFA) action date of
December 21, 2014. Cubist is seeking FDA approval of
ceftolozane/tazobactam for the treatment of complicated urinary
tract Infections and complicated intra-abdominal infections.
The NDA 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 FDA and the European Medicines Agency (EMA)
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 that the FDA accepted the NDA with Priority
Review for ceftolozane/tazobactam. We look forward to working with
the FDA on the review, and hope to bring this potential new
treatment option to physicians and their patients to address
resistant Gram-negative infections,” said Steven Gilman, Ph.D.,
Executive Vice President of Research and Development and Chief
Scientific Officer of Cubist. “This important milestone reinforces
our global commitment to advance the development of antibiotics to
combat serious public health threats.”
In 2013, the FDA designated ceftolozane/tazobactam as a
Qualified Infectious Disease Product (QIDP), according to the
Generating Antibiotic Incentives Now (GAIN) Act, for its potential
indications of cUTI and cIAI. The QIDP designation for
ceftolozane/tazobactam allows for certain incentives related to the
development of new antibiotics, including eligibility for Fast
Track status, Priority Review, and, if approved by the FDA, a five
year extension of Hatch-Waxman exclusivity.
During the second half of 2014, Cubist expects to submit a
Marketing Authorization Application (MAA) to the EMA for
ceftolozane/tazobactam for the treatment of complicated urinary
tract infections and complicated intra-abdominal infections.
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) 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 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 anticipated
PDUFA action date for our NDA for ceftolozane/tazobactam; the
therapeutic potential of ceftolozane/tazobactam; the anticipated
favorable impact resulting from the FDA designating
ceftolozane/tazobactam as a QIDP, including if
ceftolozane/tazobactam is ultimately approved by the FDA, a five
year extension of Hatch-Waxman exclusivity; positive results from
our Phase 3 clinical trials of ceftolozane/tazobactam; working with
the FDA on the review of the NDA; the expected timing of submitting
an MAA for ceftolozane/tazobactam to the EMA; 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 the
U.S. and Europe, including the risk that the FDA may not approve on
a timely basis or at all, our NDA 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 NDA may take
longer than anticipated, including as a result of internal FDA
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 maintain
and enforce intellectual property protection for
ceftolozane/tazobactam; competitive risks from current and future
therapeutic alternatives to ceftolozane/tazobactam; we may not be
able to submit an MAA for ceftolozane/tazobactam on our anticipated
timeline; 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.
Cubist Contacts:INVESTORS:Eileen C. McIntyre, 781-860-8533Vice
President, Investor
Relationseileen.mcintyre@cubist.comorMEDIA:Jennifer Baird, 781-860-1282Director,
Product Communicationsjennifer.baird@cubist.com