Cubist Pharmaceuticals CBST today announced that the U.S. Food
and Drug Administration (FDA) has accepted the Company's New Drug Application
(NDA) for its investigational antibiotic tedizolid phosphate (TR-701) with
Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA)
action date of June 20, 2014. Cubist is seeking FDA approval of tedizolid for
the treatment of acute bacterial skin and skin structure infections (ABSSSI).
Tedizolid phosphate is an oxazolidinone being developed for both intravenous
(I.V.) and oral administration for the treatment of serious Gram-positive
infections, including those caused by methicillin-resistant Staphylococcus
aureus (MRSA). The NDA submission is based on positive data from two global
Phase 3 clinical studies of tedizolid in ABSSSI, which met the primary and
secondary endpoints defined by the FDA and the European Medicines Agency
(EMA).
Earlier in 2013, the FDA designated tedizolid as a Qualified Infectious
Disease Product (QIDP), according to the Generating Antibiotic Incentives Now
(GAIN) Act, for its potential indication in ABSSSI. The QIDP designation for
tedizolid phosphate has allowed for certain incentives related to the
development of new antibiotics, including eligibility for Priority Review and,
if tedizolid phosphate is ultimately approved by the FDA, a five year
extension of Hatch-Waxman exclusivity.
“We are pleased to receive NDA acceptance for tedizolid, and look forward to
working closely with the Agency on this Priority Review,” said Steven Gilman,
Ph.D., Executive Vice President of Research and Development and Chief
Scientific Officer of Cubist Pharmaceuticals. “If approved, we expect
tedizolid will address the serious public health threat of MRSA and offer a
new treatment option for patients with serious skin infections.”
During the first half of 2014 Cubist expects to submit a Marketing
Authorization Application (MAA) for tedizolid to the EMA in the ABSSSI
indication. Cubist is also expecting to submit a New Drug Submission (NDS) to
Health Canada in the same timeframe.
About ABSSSI
Acute bacterial skin and skin structure infections (ABSSSI) are a significant
and growing problem throughout the world. ABSSSI are infections that 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 but the two most common Gram-positive pathogens are Staphylococcus
aureus and Streptococcus pyogenes. The significant increase in the incidence
of MRSA hospital-acquired infections, as well as community infections, has
resulted in a need for therapy of ABSSSI that is effective against MRSA.
About MRSA
According to the 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 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 80,461 severe MRSA infections and 11,285 deaths from MRSA
per year. Overall, staph bacteria remain a leading cause of
healthcare-associated infections (HAI). The European Centre for Disease
Prevention and Control (ECDC) estimates that more than four million EU
patients acquire HAI annually, resulting in 37,000 deaths.
About tedizolid phosphate
Cubist added tedizolid phosphate to its pipeline through the acquisition of
Trius Therapeutics, completed in September 2013. Cubist submitted a New Drug
Application to the FDA for the approval of tedizolid in October 2013.
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 phosphate is being
developed for both I.V. and oral administration in the potential treatment of
acute bacterial skin and skin structure infections (ABSSSI). Tedizolid
phosphate 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 in 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 rate
was low for both tedizolid and linezolid treated patients. Gastrointestinal
adverse events (diarrhea, nausea and vomiting) were the most commonly reported
in both treatment groups, with the incidence of these events being lower in
patients receiving tedizolid. 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 is
investing over $300M USD in 2013 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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and other federal
securities laws. Any statements contained herein which do not describe
historical facts, including but not limited to, statements regarding: results
from Cubist's Phase 3 clinical studies of tedizolid phosphate; the therapeutic
potential of tedizolid phosphate; the anticipated favorable impact resulting
from the FDA designating tedizolid phosphate as a QIDP, including if tedizolid
phosphate is ultimately approved by the FDA, a five year extension of
Hatch-Waxman exclusivity; the expected timing for submitting additional
marketing authorization applications to foreign regulatory authorities,
including the EMA and Health Canada; 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 and 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 phosphate or may
require additional data, analysis, information or further studies that may not
be clinically feasible or financially practicable; the review of our NDA may
take longer than anticipated due to internal FDA constraints; any marketing
approval for tedizolid phosphate may impose significant limitations on its use
and additional post-marketing requirements; our ability to successfully
commercialize tedizolid phosphate, 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 phosphate; our ability to maintain and enforce intellectual property
protection for tedizolid phosphate; we may not be able to submit additional
marketing authorization applications for tedizolid phosphate on our
anticipated timelines; additional clinical trials of tedizolid phosphate,
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 phosphate,
including our ability to work with our third party contract manufacturers that
manufacture and supply tedizolid phosphate on our behalf; we may encounter
other unanticipated or unexpected risks with respect to the development or
manufacture of tedizolid phosphate; 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.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in