– XERAVA™ Achieved High Clinical Cure Rates
in Clinical Trials in Patients with cIAI –
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 that the U.S. Food and Drug Administration (FDA)
has granted approval of XERAVA™ (eravacycline) for the
treatment of complicated intra-abdominal infections (cIAI). In
clinical trials, XERAVA was well-tolerated and achieved high
clinical cure rates in patients with cIAI, demonstrating
statistical non-inferiority to two widely used comparators –
ertapenem and meropenem.
XERAVA is indicated for the treatment of complicated
intra-abdominal infections in patients 18 years of age and older.
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.
“The approval of XERAVA is an extraordinary achievement, one for
which we thank the patients who have participated in our clinical
studies, study investigators and physicians as well as our
dedicated employees,” said Guy Macdonald, President and Chief
Executive Officer of Tetraphase. “We are thrilled to have received
FDA approval, and a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) in Europe all within the
same quarter. Each milestone is a significant accomplishment on its
own and achieving both underscores the potential for Tetraphase and
the medical need for XERAVA.”
Mr. Macdonald added, “We will now turn our efforts towards
delivering XERAVA to patients suffering from cIAI in the United
States, an important goal we expect to begin executing on in the
fourth quarter of this year. We look forward to a successful launch
and commercialization moving forward.”
“Complicated intra-abdominal infections are the second-most
prevalent infection site in intensive care units (ICUs), as well as
the second leading cause of infection-related mortality in ICUs,”
said Philip S. Barie, MD, MBA, Professor of Surgery and
Professor of Public Health in Medicine at Weill Cornell Medicine,
and an attending surgeon at New York-Presbyterian/Weill Cornell
Medical Center in New York City. “With the growing crisis of
antibiotic resistance, treatment options for these polymicrobial
infections are limited following surgery or percutaneous drainage,
and the causative pathogens may be multi-drug resistant. Current
empiric treatments for cIAI have limitations, and there is a need
for new and novel treatments. Eravacycline has a broad spectrum of
antibacterial activity and a clinical profile that addresses this
unmet medical need.”
Dr. Barie added, “Eravacycline also has a favorable safety
profile as observed in clinical trials, and no dose adjustment is
required when given to patients with renal impairment, which is
advantageous for seriously ill patients who may have impaired
kidney function. Additionally, the drug may be given safely to
patients who are allergic to penicillin. This new and novel
treatment may be of great benefit to patients with complicated
intra-abdominal infections.”
Intra-abdominal infection (IAI) is a common problem in clinical
practice and 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 (cIAI) 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 to 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.
“Today’s FDA approval of XERAVA provides a new weapon in the
battle against antibiotic resistance and addresses an unmet medical
need for patients suffering from multi-drug resistant infections
and other serious infections” said Rick A. Bright Ph.D., Director
of the Biomedical Advanced Research and Development Authority
(BARDA). “We are pleased to have provided support to Tetraphase
since 2012, through its collaboration with CUBRC, to develop this
new antibiotic treatment. The drug’s approval underscores the value
of public-private partnerships in addressing global health threats
and the challenge of antibiotic resistance.”
Conference Call InformationTetraphase will host
a conference call today at 4:30 p.m. Eastern Time to discuss the
FDA approval. The call can be accessed by dialing (844)
831-4023 (U.S. and Canada) or (731) 256-5215 (international) and
entering conference ID number 2585575. To access the live audio
webcast, or the subsequent archived recording, visit the "Investors
Relations — Events & Presentations" section of the Tetraphase
website at www.tphase.com.
A replay of the conference call will be available from 7:30 p.m.
ET on Monday, August 27, 2018, through 7:30 p.m. ET on Wednesday,
September 25, 2018, and may be accessed by visiting Tetraphase’s
website or by dialing 1-855-859-2056 (U.S. and Canada) and
1-404-537-3406 for (international) callers. The conference ID
number is 2585575.
Important Safety Information
XERAVA is a tetracycline class antibacterial indicated for the
treatment of complicated intra‑abdominal infections in patients 18
years of age and older.
XERAVA is not indicated for the treatment of complicated urinary
tract infections.
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.
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 8 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 8 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, nausea, and
vomiting.
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.
About XERAVA™ XERAVA
(eravacycline for injection) is a novel, fully-synthetic
fluorocycline, FDA-approved antibiotic for the treatment of cIAI.
XERAVA has demonstrated potent activity against MDR pathogens.
XERAVA was investigated for the treatment of cIAI as part of the
Company's IGNITE (Investigating
Gram-Negative
Infections Treated with
Eravacycline) phase 3 programs. In the first
pivotal phase 3 trial in patients with cIAI, twice-daily
intravenous (IV) eravacycline 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 eravacycline
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.
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 MDR bacteria highlighted as urgent public
health threats by the WHO and CDC. The Company has created more
than 3,000 novel tetracycline compounds using its proprietary
technology platform. Tetraphase's lead product,
XERAVA™ (eravacycline) is FDA-approved for the treatment of
complicated intra-abdominal infections (cIAI), has received a
positive opinion from the CHMP for cIAI, and is under consideration
for potential marketing approval by the European Commission for
cIAI. 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 eravacycline 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 August 27, 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.
Media and Investor Contact:Tetraphase
PharmaceuticalsJennifer Viera617-600-7040jviera@tphase.com
Photos accompanying this announcement are available
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