Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that
the European Medicines Agency (EMA) has accepted for review the
Company’s Marketing Authorization Application (MAA) for its
investigational antibiotic tedizolid phosphate. Cubist is seeking
approval of tedizolid for the treatment of complicated skin and
soft tissue infections (cSSTI), with a decision from the European
Commission (EC) expected during the first half of 2015.
Tedizolid 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 MAA submission is based on positive data from
two global Phase 3 clinical studies of tedizolid, which met the
primary and secondary endpoints defined by the EMA and U.S. Food
and Drug Administration (FDA).
“We are very pleased to receive MAA acceptance for tedizolid and
to work with the EMA on this important review process,” said Steve
Gilman, Ph.D., Executive Vice President of Research and Development
and Chief Scientific Officer of Cubist Pharmaceuticals. “As we
continue to build out our global infrastructure, this is a
significant development in our ongoing mission to advance potential
new antibiotics for patients facing serious bacterial infections,
such as MRSA, around the world.”
Prior to the EMA acceptance of the MAA, the FDA accepted the
Company’s New Drug Application (NDA) for tedizolid with Priority
Review and assigned an action date of June 20, 2014. The FDA has
asked Cubist to participate in a meeting of its Anti-Infective
Drugs Advisory Committee (AIDAC) on March 31, 2014. The AIDAC will
review data supporting the Company’s NDA for tedizolid, for which
Cubist is seeking approval in acute bacterial skin and skin
structure infections (ABSSSI).
Additionally, Cubist expects to submit a New Drug Submission
(NDS) to Health Canada during the first half of 2014 in acute
bacterial skin and skin structure infections (ABSSSI).
About Serious Skin, Skin Structure and Soft Tissue
Infections
Complicated skin and soft tissue infections (cSSTI) and
acute bacterial skin and skin structure infections (ABSSSI) are a
significant and growing problem throughout the world. These
infections 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 cSSTI and
ABSSSI 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
The European Centre for Disease Prevention and Control (ECDC)
estimates that more than four million European Union (EU) patients
acquire healthcare-associated 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
methicillin-resistant Staphylococcus aureus (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. 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
MRSA, which continues to be a clinical and economic burden. Based
on CDC data, there are 80,461 severe MRSA infections and 11,285
deaths from MRSA in the U.S. per year.
About tedizolid phosphate
Tedizolid phosphate (also known as TR-701) is a novel
oxazolidinone antibiotic drug candidate that is rapidly converted
in vivo by phosphatases to the microbiologically active moiety
TR-700. TR-700 is a protein synthesis inhibitor that interacts with
the 23S ribosomal ribonucleic acid (rRNA) of the bacterial
ribosome, thereby preventing the initiation of translation by
inhibiting formation of the initiation complex. Tedizolid is being
developed for both I.V. and oral administration in the potential
treatment of complicated skin and soft tissue infections (cSSTI)
and acute bacterial skin and skin structure infections (ABSSSI).
Tedizolid is also being developed 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 cSSTI and ABSSSI 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. For more
information visit: http://www.cubist.com/products/tedizolid.
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 expected
timing for the EC reaching a decision on Cubist’s MAA for tedizolid
phosphate; positive results from our Phase 3 clinical studies of
tedizolid; the therapeutic potential of tedizolid; the expected
timing for submitting a New Drug Submission to Health Canada for
tedizolid in ABSSSI; the expected timing of the FDA AIDAC meeting
and action date for our tedizolid NDA submission with the FDA; our
build out of our global infrastructure; 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 Europe and the U.S.,
including the risk that the EMA, EC, FDA and other foreign
regulatory authorities may not agree with our interpretation of the
results from the clinical studies of tedizolid, may not approve on
a timely basis or at all, our marketing authorization applications
for tedizolid 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
tedizolid may impose significant limitations on its use and
additional post-marketing requirements; our ability to obtain
adequate pricing and reimbursement levels for tedizolid; our
ability to successfully commercialize tedizolid, 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 tedizolid; our
ability to maintain and enforce intellectual property protection
for tedizolid; we may not be able to submit additional marketing
authorization applications for tedizolid on our anticipated
timelines; additional clinical trials of tedizolid, 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 tedizolid, including our ability to work with our third
party contract manufacturers that manufacture and supply tedizolid
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
tedizolid; 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.
INVESTORS:Cubist Pharmaceuticals,
Inc.Eileen C. McIntyre, 781-860-8533Vice President, Investor
Relationseileen.mcintyre@cubist.comorMEDIA:US Media:Cubist Pharmaceuticals,
Inc.Jennifer Baird, 781-860-1282Director of Product
Communicationsjennifer.baird@cubist.comorEurope Media:Weber
ShandwickNivey Nocher, +44 (0) 207 067 0143Account Director,
Healthnnocher@webershandwick.com