Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced today that
the U.S. Food and Drug Administration (FDA) Anti-Infective Drugs
Advisory Committee (AIDAC) voted to recommend approval of Cubist’s
investigational antibiotic SIVEXTRO™ (tedizolid phosphate). In the
unanimous 14 - 0 decision, the AIDAC found that substantial
evidence of the safety and effectiveness of SIVEXTRO for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI) was provided.
SIVEXTRO is a once daily oxazolidinone being developed for both
intravenous (I.V.) and oral administration for the treatment of
serious infections caused by certain Gram-positive bacteria,
including those caused by methicillin-resistant Staphylococcus
aureus (MRSA). The Company’s New Drug Application (NDA) submission
to the FDA for SIVEXTRO is based on positive data from two global
Phase 3 clinical studies, which met the primary and secondary
endpoints defined by the FDA and European Medicines Agency
(EMA).
“We are very pleased with the strong endorsement from AIDAC
members, and recommendation of approval for tedizolid, now known in
the U.S. as SIVEXTRO. We are encouraged by the recognition that
there is a need for more treatment options for patients to address
serious skin infections,” said Steven Gilman, Ph.D., Executive Vice
President of Research and Development and Chief Scientific Officer
of Cubist Pharmaceuticals. “We look forward to the FDA’s final
review of SIVEXTRO and decision.”
The AIDAC recommendation is not binding on the FDA, but will
help inform the FDA as it completes its Priority Review of the NDA
for SIVEXTRO, which has an assigned action date of June 20, 2014.
More information about the AIDAC meeting is available on the FDA
website here.
Additionally, the EMA recently accepted for review the Company’s
Marketing Authorization Application (MAA) for the investigational
antibiotic, for which Cubist is
seeking approval for the treatment of complicated skin and soft
tissue infections (cSSTI). A decision from the European Commission
(EC) is expected during the first half of 2015.
Tedizolid phosphate (formerly TR-701), now known in the U.S. as
SIVEXTRO, is a novel oxazolidinone antibiotic drug candidate that
is rapidly converted in vivo by phosphatases to the
microbiologically active moiety TR-700. TR-700 acts by binding to
the bacterial 50S ribosomal subunit thereby inhibiting protein
synthesis. Tedizolid is being developed for both I.V. and oral
administration in the potential treatment of ABSSSI, also referred
to as cSSTI. Tedizolid is also being investigated for potential use
in nosocomial pneumonia (hospital-acquired bacterial pneumonia
[HABP] and ventilator-associated bacterial pneumonia [VABP]). Two
Phase 3 studies, conducted in the U.S., Europe and other regions
worldwide, in ABSSSI and cSSTI demonstrated that tedizolid 200 mg
once daily for six days was statistically non-inferior to 10 days
of linezolid 600 mg twice daily for the primary efficacy endpoints.
Secondary endpoints were also met. In these studies, the adverse
event rates were similar for both tedizolid and linezolid treated
patients. Gastrointestinal adverse events (diarrhea, nausea and
vomiting) were the most commonly reported in both treatment
groups.
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.
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: positive
results from Cubist’s Phase 3 clinical studies of SIVEXTRO; the
FDA’s final review of and decision on our SIVEXTRO NDA submission,
including that the AIDAC recommendation will help inform the FDA’s
review; the expected timing of the FDA’s action date for our
SIVEXTRO NDA submission and for the EC reaching a decision on our
MAA for SIVEXTRO; the therapeutic potential of SIVEXTRO, including
that we are developing SIVEXTRO for potential indications in
ABSSSI/cSSTI, HABP and 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: that the FDA’s review and decision on our SIVEXTRO
NDA submission may be affected by issues not discussed by the AIDAC
and the FDA is not bound by and may not agree with the AIDAC’s
recommendation; regulatory developments in the U.S. and Europe,
including the risk that the FDA, EMA, EC and other foreign
regulatory authorities may not agree with our interpretation of the
results from the clinical studies of SIVEXTRO, may not approve on a
timely basis or at all, our marketing authorization applications
for SIVEXTRO or may require additional data, analysis, information
or further studies that may not be clinically feasible or
financially practicable; the review of our marketing authorization
applications may take longer than anticipated due to internal
regulatory authority constraints; any marketing approval for
SIVEXTRO may impose significant limitations on its use and
additional post-marketing requirements; our ability to obtain
adequate pricing and reimbursement levels for 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
availability or commercial potential; 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 or excessive costs 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; 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
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 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 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 of
Product Communicationsjennifer.baird@cubist.com