FDA-Approved for the Treatment of Complicated
Intra-Abdominal Infections
Tetraphase Pharmaceuticals, Inc.
(NASDAQ:TTPH), a biopharmaceutical company focused on developing
and commercializing novel antibiotics to treat life-threatening
multidrug-resistant (MDR) infections, today announced the U.S.
commercial launch of XERAVA™ (eravacycline) for the treatment of
complicated intra-abdominal infections (cIAI). The wholesale
acquisition cost (WAC) of XERAVA will be $175 per day of therapy to
support the Company’s strategy of having XERAVA used for the
empiric treatment of cIAI.
“The launch of XERAVA marks an important milestone for
Tetraphase and for physicians with patients in need of a new
broad-spectrum antibiotic for serious, often life-threatening,
multidrug-resistant infections,” said Guy Macdonald, President and
Chief Executive Officer of Tetraphase. “This important achievement
marks the culmination of many years of dedication and follows the
regulatory approvals of XERAVA both by the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency.
“We are well-prepared for the commercial success of XERAVA with
a strong and experienced sales team who are fully-trained and
deployed to make the treatment widely available to patients in
need,” said Larry Edwards, Chief Operating Officer of Tetraphase.
“With a WAC price of $175 per treatment day, XERAVA is well-suited
for empiric use and is now available to hospitals to treat a range
of appropriate patients with empiric and confirmed infections. The
salesforce will be focusing on healthcare institutions responsible
for treating the highest concentrations of Gram-negative
infections, covering approximately 90% of the Gram-negative
marketplace.”
About Complicated Intra-Abdominal
Infections
Intra-abdominal infection (IAI) comprises a wide variety of
disease processes. IAI is classified as uncomplicated or
complicated based on the extent of the infection. Complicated
intra-abdominal infections extend beyond the source organ into the
peritoneal space (the space between the two membranes that separate
the organs in the abdominal cavity from the abdominal wall) as a
result of perforation or other damage to the gastrointestinal
tract. cIAI diagnoses include intra-abdominal abscess, stomach or
intestinal perforation, peritonitis, appendicitis, cholecystitis or
diverticulitis. Different bacterial pathogens are responsible for
cIAI, including Gram-negative aerobic bacteria, Gram-positive
bacteria and anaerobic bacteria. Early detection, containment and
appropriate antimicrobial treatment are essential for the
successful treatment of IAI. This is even more critical with
increasing rates of infections caused by drug-resistant bacteria,
which limit the effectiveness of currently available
antibiotics.
About XERAVATM
XERAVA (eravacycline for injection) is a tetracycline class
antibacterial indicated for the treatment of complicated
intra-abdominal infections (cIAI) in patients 18 years of age and
older. XERAVA was investigated for the treatment of cIAI as part of
the Company's IGNITE (Investigating
Gram-Negative
Infections Treated with
Eravacycline) Phase 3 program. In the first
pivotal Phase 3 trial in patients with cIAI, twice-daily
intravenous (IV) XERAVA met the primary endpoint by demonstrating
statistical non-inferiority of clinical response compared to
ertapenem and was well-tolerated. In the second Phase 3 clinical
trial in patients with cIAI, twice-daily IV XERAVA met the primary
endpoint by demonstrating statistical non-inferiority of clinical
response compared to meropenem and was well-tolerated. In both
trials, XERAVA achieved high cure rates in patients with
Gram-negative pathogens, including resistant isolates.
Indications and Usage
XERAVA is indicated for the treatment of complicated
intra-abdominal infections (cIAI) caused by susceptible
microorganisms: Escherichia coli, Klebsiella pneumoniae,
Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca,
Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus,
Streptococcus anginosus group, Clostridium perfringens, Bacteroides
species, and Parabacteroides distasonis in patients 18 years or
older.
Limitations of Use
XERAVA is not indicated for the treatment of complicated urinary
tract infections (cUTI).
Usage
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of XERAVA and other antibacterial drugs,
XERAVA should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they
should be considered in selecting or modifying antibacterial
therapy. In the absence of such data, local epidemiology and
susceptibility patterns may contribute to the empiric selection of
therapy.
Important Safety Information
XERAVA is contraindicated for use in patients with known
hypersensitivity to eravacycline or to tetracycline-class
antibacterial drugs. Life-threatening hypersensitivity
(anaphylactic) reactions have been reported with XERAVA.
The use of XERAVA during tooth development (last half of
pregnancy, infancy and childhood to the age of eight years) may
cause permanent discoloration of the teeth (yellow-gray-brown) and
enamel hypoplasia.
The use of XERAVA during the second and third trimester of
pregnancy, infancy and childhood up to the age of eight years may
cause reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials
(incidence ≥ 3%) were infusion site reactions (7.7%), nausea
(6.5%), and vomiting (3.7%).
XERAVA is structurally similar to tetracycline-class
antibacterial drugs and may have similar adverse reactions. Adverse
reactions including photosensitivity, pseudotumor cerebri, and
anti-anabolic action which has led to increased BUN, azotemia,
acidosis, hyperphosphatemia, pancreatitis, and abnormal liver
function tests, have been reported for other tetracycline-class
antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA
if any of these adverse reactions are suspected.
To report SUSPECTED ADVERSE REACTIONS, contact
Tetraphase Pharmaceuticals Inc., at 1-833- 7-XERAVA
(1-833-793-7282) or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
Please see full prescribing information for XERAVA at
www.XERAVA.com.
About Tetraphase Pharmaceuticals,
Inc.Tetraphase is a biopharmaceutical company using its
proprietary chemistry technology to create novel antibiotics for
serious and life-threatening bacterial infections, including those
caused by many of the multidrug-resistant bacteria highlighted as
urgent public health threats by the World Health Organization and
the Centers for Disease Control and Prevention. The Company has
created more than 3,000 novel tetracycline compounds using its
proprietary technology platform. Tetraphase's lead product XERAVA
is approved for the treatment of complicated intra-abdominal
infections by the U.S. Food and Drug Administration and the
European Medicines Agency. The Company’s pipeline also includes
TP-271 and TP-6076, which are in phase 1 clinical trials. Please
visit www.tphase.com for more company information.
Forward-Looking StatementsAny statements in
this press release about our future expectations, plans and
prospects, including statements regarding our strategy, future
operations, prospects, plans and objectives, and other statements
containing the words "anticipates," "believes," "expects," "plans,"
"will" and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including whether XERAVA will be successfully
distributed and marketed and other regulatory and commercial risk
factors discussed in the "Risk Factors" section of our quarterly
report on Form 10-Q for the period ended June 30, 2018, filed with
the Securities and Exchange Commission on August 2, 2018. In
addition, the forward-looking statements included in this press
release represent our views as of October 11, 2018. We anticipate
that subsequent events and developments will cause our views to
change. However, while we may elect to update these forward-looking
statements at some point in the future, we specifically disclaim
any obligation to do so.
Investor and Media Contacts:Tetraphase
PharmaceuticalsJennifer
Viera617-600-7040jviera@tphase.com
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