SIVEXTRO is a short, six-day course of
therapy to treat serious skin infections, including those caused by
MRSA
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announces SIVEXTRO™
(tedizolid phosphate) indicated for the treatment of adult acute
bacterial skin and skin structure infections (ABSSSI) is now
available in the U.S. in once-daily I.V. and oral formulations.
Approved by the U.S. Food and Drug Administration (FDA) on June 20,
2014, SIVEXTRO addresses ABSSSI caused by susceptible Gram-positive
bacteria, including methicillin-resistant Staphylococcus aureus
(MRSA)— which has been categorized by the U.S. Centers for Disease
Control and Prevention (CDC) as a serious public health threat.
“We are pleased to formally announce the availability of the
I.V. version of SIVEXTRO for physician and hospital order in the
U.S.,” said Rob Perez, President and Chief Operating Officer of
Cubist. “SIVEXTRO oral has been on the market since late June. We
believe the features and utility of SIVEXTRO offers physicians an
effective option to treat acute bacterial skin and skin structure
infections in a number of real-life patient settings—from the
hospital to the home.”
The approval of SIVEXTRO marks one of at least four antibiotics
Cubist hopes to deliver in support of the Infectious Diseases
Society of America challenge to industry and policy makers to
develop and approve 10 new antibiotics by 2020.
The EMA has accepted for review Cubist’s Marketing Authorization
Application (MAA) for SIVEXTRO, for which the company is seeking
approval for the treatment of complicated skin and soft tissue
infections (cSSTI). A decision from the European Commission is
expected during the first half of 2015.
Clinical studies are also ongoing for the potential use of
SIVEXTRO in the treatment of hospital-acquired bacterial pneumonia
(HABP)/ventilator-associated bacterial pneumonia (VABP).
About SIVEXTROTM (tedizolid phosphate)
Administered once daily, SIVEXTRO offers an effective, short
six-day course of therapy. SIVEXTRO is a novel oxazolidinone with
in vitro activity against clinically significant susceptible
Gram-positive pathogens including MRSA and is available in both
intravenous (I.V.) and oral formulations.
The New Drug Application (NDA) for SIVEXTRO was supported by two
global Phase 3 studies, which met primary and secondary endpoints
defined by the FDA and the European Medicines Agency (EMA). These
studies demonstrated that SIVEXTRO 200 mg administered once daily
for six days was statistically non-inferior to 600 mg of linezolid
taken twice a day for 10 days. In these studies, the adverse event
rates were similar for patients treated with SIVEXTRO and
linezolid. Gastrointestinal adverse events (diarrhea, nausea and
vomiting) were the most commonly reported in both treatment
groups.
SIVEXTRO is one of the first medicines approved in the U.S. that
the FDA designated as a Qualified Infectious Disease Product (QIDP)
for its indication, ABSSSI, according to the Generating Antibiotic
Incentives Now (GAIN) Act of 2012. The QIDP designation qualified
SIVEXTRO for certain incentives related to the development of new
antibiotics, including a five year extension of Hatch-Waxman
exclusivity.
Patients seeking assistance may be eligible for program benefits
provided through AccessSIVEXTRO.
Indication and Important Safety Information
Indication
SIVEXTROTM (tedizolid phosphate) is indicated for the treatment
of acute bacterial skin and skin structure infections (ABSSSI)
caused by susceptible isolates of the following Gram-positive
microorganisms: Staphylococcus aureus (including
methicillin-resistant [MRSA] and methicillin-susceptible [MSSA]
isolates), Streptococcus pyogenes, Streptococcus agalactiae,
Streptococcus anginosus group (including Streptococcus anginosus,
Streptococcus intermedius and Streptococcus constellatus), and
Enterococccus faecalis.
Warnings and Precautions
- Patients with neutropenia: The
safety and efficacy of SIVEXTRO in patients with neutropenia
(neutrophil counts <1000 cells/mm3) have not been adequately
evaluated. In an animal model of infection, the antibacterial
activity of SIVEXTRO was reduced in the absence of granulocytes.
Alternative therapies should be considered when treating patients
with neutropenia.
- Clostridium
difficile–associated diarrhea (CDAD), ranging from mild
diarrhea to fatal colitis, has been reported with nearly all
systemic antibacterial agents, including SIVEXTRO. Evaluate all
patients who present with diarrhea following SIVEXTRO use.
- Development of drug-resistant
bacteria: Prescribing SIVEXTRO in the absence of a proven or
strongly suspected bacterial infection or prophylactic indication
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 SIVEXTRO are nausea,
headache, diarrhea, vomiting, and dizziness.
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 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. In addition to a
focus on Gram-positive pathogens, Cubist’s commitment also includes
a focus on Gram-negative pathogens. In this regard, Cubist recently
received acceptance of its NDA to the FDA for approval of its
investigational antibiotic ceftolozane/tazobactam, being developed
to address certain Gram-negative bacteria, for the treatment of
Complicated Urinary Tract Infections (cUTI) and Complicated
Intra-Abdominal Infections (cIAI). The assigned action date for the
ceftolozane/tazobactam NDA is December 21, 2014.
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.
About Acute Skin, Skin Structure and Soft Tissue
Infections
Acute bacterial skin and skin structure infections (ABSSSI) are
also referred to as complicated skin and soft tissue infections
(cSSTI) (in Europe). These infections, which are a significant and
growing problem throughout the world, involve deeper tissue or
require surgical intervention (e.g., cellulitis, major cutaneous
abscesses and infected wounds) or are associated with a significant
underlying disease (e.g., diabetes or systemic immunosuppression)
that complicates response to therapy. A variety of pathogens may be
identified in ABSSSI/cSSTI but the two most
common Gram-positive pathogens are Staphylococcus
aureus and Streptococcus pyogenes. The significant
increase in the incidence of
methicillin-resistant Staphylococcus aureus (MRSA)
healthcare-associated infections (HAIs), as well as community
infections, has resulted in a need for therapies to address serious
skin, skin structure and soft tissue infections that are effective
against MRSA.
About MRSA
According to the U.S. Centers for Disease Control and Prevention
(CDC) “Antibiotic resistance threats in the United States,
2013” report, each year more than two million Americans
develop infections from antibiotic-resistant bacteria. One of the
serious public health threats identified by the CDC is
methicillin-resistant Staphylococcus aureus (MRSA), which
continues to be a clinical and economic burden. Based on CDC data,
there are approximately 80,000 severe MRSA infections and 11,000
deaths from MRSA in the U.S. per year. The European Centre for
Disease Prevention and Control (ECDC) estimates that more than
four million European Union (EU) patients acquire healthcare
acquired infections (HAIs) annually, resulting in 37,000 deaths and
that a large proportion of these deaths are due to the most common
multidrug-resistant bacteria, including MRSA. According
to the ECDC, MRSA is still the most commonly identified
antimicrobial-resistant pathogen in hospitals in many parts of the
world, including Europe, the Americas, North Africa, the Middle
East, and Asia. Data from the Eurosurveillance journal
estimates MRSA infections affect more than 150,000 patients
annually in the EU.
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
and commercial potential of SIVEXTRO and ceftolozane/tazobactam;
the expected timing for the European Commission’s decision on our
MAA for SIVEXTRO; the anticipated FDA action date for our
ceftolozane/tazobactam NDA; clinical studies investigating SIVEXTRO
for the potential treatment of HABP/VABP; our aspirations to
achieve a portion of the IDSA’s 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
United States, Europe and other foreign countries, 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, and the risk that the FDA may impose
post-marketing requirements on SIVEXTRO and that the European
Commission may not agree with our interpretation of the results
from the clinical studies of SIVEXTRO; the review of our
ceftolozane/tazobactam NDA may take longer than anticipated,
including as a result of internal FDA constraints; our ability to
successfully commercialize SIVEXTRO, 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 SIVEXTRO;
competitive risks from current and future therapeutic alternatives
to SIVEXTRO and ceftolozane/tazobactam; our ability to maintain and
enforce intellectual property protection for SIVEXTRO and
ceftolozane/tazobactam; additional clinical trials of SIVEXTRO and
ceftolozane/tazobactam, 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
SIVEXTRO and ceftolozane/tazobactam, including our ability to work
with our third party contract manufacturers that manufacture and
supply SIVEXTRO and ceftolozane/tazobactam on our behalf; we may
encounter other unanticipated or unexpected risks with respect to
the development manufacture or supply of SIVEXTRO and
ceftolozane/tazobactam; the fact that drug discovery and
development is complex, time consuming, expensive and fraught with
a high risk of failure; 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:Elizabeth Dunavant, 781-860-8680Director,
Product Communicationselizabeth.dunavant@cubist.com