Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that
it has submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for approval of its investigational
antibiotic ceftolozane/tazobactam for the treatment of Complicated
Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal
Infections (cIAI).
Ceftolozane/tazobactam is an antibiotic candidate being
developed to treat certain Gram-negative infections. The NDA
submission is based on positive data from pivotal Phase 3 clinical
trials in complicated urinary tract infections (cUTI) and
complicated intra-abdominal infections (cIAI), which met primary
endpoints that were agreed upon with the FDA and European Medicines
Agency (EMA). Results of the secondary analyses were consistent
with and supportive of the primary outcomes.
“Ceftolozane/tazobactam has been developed to target common and
problematic Gram-negative pathogens resistant to current therapies
and found in certain types of complicated infections,” said Steven
Gilman, Ph.D., Executive Vice President of Research and Development
and Chief Scientific Officer of Cubist Pharmaceuticals. “Our NDA
submission for ceftolozane/tazobactam represents our focus at
Cubist to fight global antimicrobial resistance, and offer
potential novel treatment options to physicians for appropriate
patients.”
In 2013, the FDA granted ceftolozane/tazobactam Fast Track
status for its Qualified Infectious Disease Product (QIDP)
indications of cUTI and cIAI, as well as Hospital-Acquired
Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial
Pneumonia (VABP). The QIDP designation for ceftolozane/tazobactam,
enabled by the Generating Antibiotic Incentives Now (GAIN) Act,
allows for certain incentives related to the development of new
antibiotics, including eligibility for Fast Track status and
Priority Review, and, if ceftolozane/tazobactam is ultimately
approved by the FDA, a five year extension of Hatch-Waxman
exclusivity.
Cubist expects to submit a Marketing Authorization Application
(MAA) for ceftolozane/tazobactam to the EMA in the cUTI and cIAI
indications during the second half of 2014. Additionally, the
Company is currently in the process of initiating investigational
sites for a pivotal Phase 3 clinical trial of
ceftolozane/tazobactam in HABP/ VABP.
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 β-lactamase inhibitor. The addition of tazobactam
broadens coverage to include most Extended-spectrum β-lactamase
(ESBL)-producing Escherichia coli (E. coli), Klebsiella pneumoniae,
and other Enterobacteriaceae. Ceftolozane/tazobactam is being
developed for the potential treatment of Complicated Urinary Tract
Infections (cUTI) and Complicated Intra-Abdominal Infections
(cIAI). In pivotal Phase 3 clinical trials of
ceftolozane/tazobactam in cUTI when studied against levofloxacin
and of ceftolozane/tazobactam, in combination with metronidazole,
in cIAI when studied against meropenen, ceftolozane/tazobactam met
its primary endpoints of statistical non-inferiority.
Ceftolozane/tazobactam is also being developed for the potential
treatment of Hospital-Acquired Bacterial Pneumonia
(HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) at a dose
of 3 g every 8 hours. Ceftolozane/tazobactam has been granted Fast
Track status, pursuant to the GAIN Act, by the U.S. Food and Drug
Administration (FDA) for its respective Qualified Infectious
Disease Product (QIDP) indications. The QIDP designation for
ceftolozane/tazobactam allows for certain incentives related to the
development of new antibiotics, including eligibility for Fast
Track status and Priority Review.
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
β-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 R&D of antibiotics to treat serious and
life-threatening infections caused by a broad range of increasingly
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 therapeutic
potential of ceftolozane/tazobactam; the anticipated favorable
impact resulting from the FDA designating ceftolozane/tazobactam as
a QIDP, including Fast Track status, Priority Review and 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; the expected
timing of submitting an MAA for ceftolozane/tazobactam to the EMA
and for beginning Phase 3 trials studying the use of
ceftolozane/tazobactam in HABP/VABP; 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 accept for filing, or
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
due to 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; our ability to achieve our strategic goals,
including as a result of our ability to continue to grow revenues
from the sale of CUBICIN® (daptomycin for injection), DIFICID®
(fidaxomicin) and ENTEREG® (alvimopan), generic and other
competition, manufacturing issues, our ability to successfully
develop, gain marketing approval for and commercially launch our
product candidates for their planned indications and on their
expected timelines, and our ability to discover, in-license or
acquire new products and product candidates and those additional
factors discussed in our most recent annual report on Form 10-K and
quarterly report 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 of
Product Communicationsjennifer.baird@cubist.com