SIVEXTRO offers a short six-day course of
therapy to physicians in once daily I.V. and oral treatment
options
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced today the
U.S. Food and Drug Administration (FDA) approved SIVEXTRO™
(tedizolid phosphate) for the treatment of adult acute bacterial
skin and skin structure infections (ABSSSI). 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.
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 now approved in both
an 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 qualifies
SIVEXTRO for certain incentives related to the development of new
antibiotics, including a five year extension of Hatch-Waxman
exclusivity.
“We are pleased by the FDA approval of SIVEXTRO, which provides
a new option for physicians to treat patients with serious
bacterial skin infections, including those caused by MRSA,” said
Michael Bonney, Chief Executive Officer of Cubist. “SIVEXTRO
provides physicians with flexibility to transition patients from
I.V. to oral treatment as required. The oral option provides
opportunity for out-patient care, which could reduce the need for
costly hospitalization. In addition, SIVEXTRO is 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.”
"MRSA is still problematic in the U.S. and is responsible for
the deaths of more than 11,000 Americans each year,” said Ralph
Corey, M.D., Professor of Medicine and Infectious Disease, Duke
Clinical Research Institute and Duke University Medical Center.
“Not every antibiotic will work for every patient and more drug
options are an imperative. Physicians should evaluate the use of
SIVEXTRO. A six-day course of therapy with the option to
choose—and, if needed—change from I.V. to oral administration is a
welcome new development.”
“I am proud to have introduced the GAIN Act, which is one
important piece of addressing the public health crisis of
untreatable infections and drug-resistant pathogens,” said Senator
Richard Blumenthal (D-CT). “Today’s announcement shows that we
are starting to see new products enter the market – which is a
promising step in addressing these life-threatening conditions. I
look forward to working with my colleagues on other initiatives to
continue the fight against deadly antimicrobial resistance.”
On March 31, 2014 an FDA Anti-Infective Drugs Advisory Committee
(AIDAC) voted to recommend approval of SIVEXTRO. In the unanimous
14 - 0 decision, the AIDAC found that substantial evidence of the
safety and effectiveness of SIVEXTRO for the treatment of ABSSSI
was provided.
Patients seeking assistance may be eligible for
AccessSIVEXTRO.
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).
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 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 submitted the 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).
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 Serious 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, including the potential for
SIVEXTRO to reduce the need for costly hospitalization; the
expected timing for the European Commission’s decision on our MAA
for SIVEXTRO; our commitment to focus on Gram-negative pathogens,
including the therapeutic potential of ceftolozane/tazobactam; 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 and foreign countries, including
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; 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; our ability to maintain and
enforce intellectual property protection for SIVEXTRO; additional
clinical trials of SIVEXTRO, 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, including our ability to work with our third party
contract manufacturers that manufacture and supply SIVEXTRO on our
behalf; we may encounter other unanticipated or unexpected risks
with respect to the development manufacture or supply of SIVEXTRO;
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 Contacts:INVESTORS:Cubist Pharmaceuticals, Inc.Eileen C.
McIntyre, 781-860-8533Vice President, Investor
Relationseileen.mcintyre@cubist.comorMEDIA:Cubist Pharmaceuticals, Inc.Elizabeth
Dunavant, 781-860-8680Director, Product
Communicationselizabeth.dunavant@cubist.com