ZERBAXA addresses certain serious and
resistant Gram-negative bacteriaFirst new antibiotic
approved in U.S. under the GAIN Act that treats Gram-negative
bacteria
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced today the
U.S. Food and Drug Administration (FDA) approved ZERBAXA™
(ceftolozane/tazobactam) for the treatment of adults with
complicated urinary tract infections (cUTI) and complicated
intra-abdominal infections (cIAI) caused by designated susceptible
Gram-negative bacteria.
“Today is an important day for patients, and we are very pleased
to arm physicians with ZERBAXA in the battle against Gram-negative
bacteria, where few treatment options exist,” said Robert J. Perez,
President and Chief Operating Officer, Cubist. “ZERBAXA
demonstrated efficacy against certain resistant bacteria in Phase 3
clinical trials for complicated urinary tract and complicated
intra-abdominal infections. The approval of ZERBAXA demonstrates
the Agency’s commitment to make available new antibiotics that
address this serious public health threat.”
The approval of ZERBAXA was supported by positive data from two
pivotal Phase 3 clinical trials—one in patients with cUTI and the
other in patients with cIAI. Both trials met the pre-specified
primary endpoints agreed upon with the FDA and European Medicines
Agency (EMA).
“The widespread prevalence of dangerous Gram-negative pathogens
together with their increased resistance to existing antibiotics
has created a serious public health threat,” said Louis B. Rice,
M.D., Joukowsky Family Professor of Medicine and Chairman of the
Department of Medicine at Warren Alpert Medical School of Brown
University, who also serves on the Board of Directors of the
Infectious Diseases Society of America (IDSA). “ZERBAXA is a
welcomed and much needed novel treatment for suspected or proven
infections caused by susceptible Gram-negative pathogens.”
ZERBAXA is the first new antibiotic approved in the U.S. under
the Generating Antibiotic Incentives Now (GAIN) Act to treat
Gram-negative bacteria. ZERBAXA is designated by the FDA as a
Qualified Infectious Disease Product (QIDP) for its indications,
according to the GAIN Act. The GAIN Act provides incentives to
develop new antibacterial drugs for the treatment of serious or
life-threatening disease or condition caused by drug resistant
pathogens. The QIDP designation qualifies ZERBAXA for certain
incentives related to the development of new antibiotics, including
a five year extension of Hatch-Waxman exclusivity. Additionally,
ZERBAXA is Cubist’s second antibiotic that has received FDA
approval this year, marking the first time this century a company
has delivered two new FDA-approved antibiotics in a single
year.
Cubist has led the way towards delivering on goals set out by
the Infectious Diseases Society of America (IDSA) call for 10 new
antibiotics by the year 2020. To read the IDSA statement related to
today’s approval of ZERBAXA visit:
www.idsociety.org/abxupdate2014.
Patients seeking assistance may be eligible for AccessZERBAXA.
For more information contact: 1-844-CUBIST-CARES
(1-844-282-4782).
About ZERBAXA and Clinical Trials
ZERBAXA is now approved in an intravenous (I.V.) formulation at
a 1.5 g q8h dose for the treatment of adults with complicated
urinary tract infections (cUTI) and complicated intra-abdominal
infections (cIAI) caused by designated susceptible Gram-negative
bacteria. ZERBAXA is a novel antipseudomonal cephalosporin with an
established beta-lactamase inhibitor.
In the Phase 3 cUTI trial, ZERBAXA met its primary endpoint of
statistical non-inferiority compared to levofloxacin (10%
non-inferiority margin). The primary endpoint was a composite of
microbiological eradication and clinical cure rate (composite cure
rate) at 5 - 9 days after end of therapy (the Test of Cure visit).
The 95% confidence interval around the treatment difference had
lower and upper bounds of 2.3% and 14.6%, respectively.
In the Phase 3 cIAI trial, ZERBAXA, in combination with
metronidazole, met the FDA and EMA defined primary endpoints of
statistical non-inferiority compared to meropenem. The primary
endpoint was a clinical cure rate 26 - 30 days after the initiation
of therapy (the Test of Cure visit). For the FDA, the primary
analysis was conducted in the Microbiological Intent-to-Treat
(MITT) population; the non-inferiority margin was 10%; and the
lower and upper bounds of the 95% confidence interval were -8.9%
and 0.5%, respectively. For the EMA, the primary analysis
population was Clinically Evaluable (CE) patients; the
non-inferiority margin was 12.5%; and the lower and upper bounds of
the 99% confidence interval were -4.2% and 4.3%, respectively.
For each of the trials, results of the secondary analyses were
consistent with and supportive of the primary outcome. The most
common adverse events for ZERBAXA across trials included nausea,
headache, and diarrhea.
The European Medicines Agency (EMA) has accepted for review the
Marketing Authorization Application (MAA) for ZERBAXA for which the
company is seeking approval for the treatment of cUTI and cIAI. A
decision from the European Commission is expected during the second
half of 2015.
Clinical studies are also ongoing for the potential use of
ZERBAXA in the treatment of hospital-acquired bacterial pneumonia
(HABP)/ventilator-associated bacterial pneumonia (VABP) at a 3 g
dose.
Indication and Important Safety Information
Indications
ZERBAXA™ (ceftolozane/tazobactam) used in combination with
metronidazole is indicated in adult patients for the treatment of
complicated intra-abdominal infections (cIAI) caused by the
following Gram-negative and Gram-positive microorganisms:
Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca,
Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa,
Bacteroides fragilis, Streptococcus anginosus, Streptococcus
constellatus, and Streptococcus salivarius.
ZERBAXA™ is indicated in adult patients for the treatment of
complicated urinary tract infections (cUTI), including
pyelonephritis, caused by the following Gram-negative
microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus
mirabilis, and Pseudomonas aeruginosa.
Important Safety Information
- Hypersensitivity: ZERBAXA is
contraindicated in patients with known serious hypersensitivity to
ceftolozane/tazobactam, piperacillin/tazobactam, or other members
of the beta-lactam class. Serious and occasionally fatal
hypersensitivity (anaphylactic) reactions have been reported in
patients receiving beta-lactam antibacterials. Before initiating
therapy with ZERBAXA, make careful inquiry about previous
hypersensitivity reactions to cephalosporins, penicillins, or other
beta-lactams. If an anaphylactic reaction to ZERBAXA occurs,
discontinue use and institute appropriate therapy.
- Patients with renal impairment:
Decreased efficacy has been observed in patients with baseline CrCl
of 30 to ≤50 mL/min. Monitor CrCl at least daily in patients with
changing renal function and adjust the dose of ZERBAXA
accordingly.
- Clostridium
difficile–associated diarrhea (CDAD), ranging from mild
diarrhea to fatal colitis, has been reported with nearly all
systemic antibacterial agents, including ZERBAXA. Careful medical
history is necessary because CDAD has been reported to occur more
than 2 months after the administration of antibacterial agents. If
CDAD is confirmed, antibacterial use not directed against C.
difficile should be discontinued, if possible.
- Development of drug-resistant
bacteria: Prescribing ZERBAXA in the absence of a proven or
strongly suspected bacterial infection is unlikely to provide
benefit to the patient and increases the risk of the development of
drug resistant bacteria.
Adverse Reactions
The most common adverse reactions for ZERBAXA are nausea,
diarrhea, headache and pyrexia.
About Gram-negative Bacteria and Certain Complicated
Infections
Gram-negative bacteria are a serious global public health
concern. The U.S. Centers for Disease Control and Prevention (CDC)
has categorized certain Gram-negative bacteria among the top most
serious threats to public health. Gram-negative bacteria are common
causes of intra-abdominal infections (IAIs) and urinary tract
infections (UTIs). E. coli is the most common cause of UTIs, and
cases of UTI caused by Pseudomonas aeruginosa, including
drug-resistant strains, are increasing. Major pathogens in
intra-abdominal infections are Enterobacteriaceae including
Escherichia coli (E. coli) and Klebsiella pneumoniae. Additionally,
Pseudomonas aeruginosa is the second most common cause of
catheter-associated UTIs.
About Cubist’s Commitment to Antibiotic R&D
For more than 20 years, Cubist has had an unwavering focus on
antibiotics. The Company 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. With one of the strongest
antibiotics pipelines in the industry, Cubist expects to invest
approximately $400M USD in 2014 on antibacterial R&D and 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. To learn more about superbugs, the threat of
resistance, and the global response visit:
http://www.cubist.com/superbugs.
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’s corporate
headquarters is based in Lexington, Massachusetts, with
international headquarters 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. To learn
more about superbugs, the threat of resistance, and the global
response visit: http://www.cubist.com/superbugs.
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 ZERBAXA; the expected timing for the European
Commission’s decision on our MAA for ZERBAXA; ongoing studies of
ZERBAXA for HABP/VABP; our aspirations to achieve a portion of the
IDSA’s goal of 10 new antibiotics by 2020; our commitment to global
public health; 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 United States and foreign countries, including
the risk that the FDA may impose post-marketing requirements on
ZERBAXA and that the European Commission may not agree with our
interpretation of the results from the clinical studies of ZERBAXA;
our ability to successfully commercialize ZERBAXA, including as a
result of regulatory authorities’ decisions regarding labeling and
other matters, including adverse side effects, that could affect
its commercial potential; the acceptance of and demand for new
pharmaceutical products; the availability of adequate pricing and
reimbursement from third-party payors for ZERBAXA;
competitive risks from current and future therapeutic alternatives
to ZERBAXA; our ability to maintain and enforce intellectual
property protection for ZERBAXA; additional clinical trials of
ZERBAXA, including in HABP/VABP, may produce negative or
inconclusive results or may not be initiated or conducted in a
timely manner; technical difficulties, excessive costs or other
issues relating to the manufacture or supply of ZERBAXA, including
our ability to work with our third party contract manufacturers
that manufacture and supply ZERBAXA on our behalf; we may encounter
other unanticipated or unexpected risks with respect to the
development manufacture or supply of ZERBAXA; the fact that drug
discovery and development is complex, time consuming, expensive and
fraught with a high risk of failure; the risk that we do not
successfully complete our planned transaction with Merck or we do
not successfully complete the transaction on the timeframe we
currently expect; 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
document, and we undertake no obligation to update or revise any of
these statements.
Cubist Pharmaceuticals, Inc.INVESTORS:Eileen C. McIntyre, 781-860-8533Vice
President, Investor
Relationseileen.mcintyre@cubist.comorMEDIA:Jennifer Baird, 781-860-1282Director,
Product Communicationsjennifer.baird@cubist.com