La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is dedicated
to the development and commercialization of innovative therapies
that improve outcomes in patients suffering from life-threatening
diseases, and Tetraphase Pharmaceuticals, Inc. (Nasdaq: TTPH), a
biopharmaceutical company focused on commercializing its novel
tetracycline XERAVA™ (eravacycline) to treat serious and
life-threatening infections, today announced the closing of La
Jolla's acquisition of Tetraphase. La Jolla acquired Tetraphase for
$43.0 million in upfront cash plus potential future cash payments
of up to $16.0 million pursuant to contingent value rights (CVRs).
The holders of the CVRs are entitled to receive payments of up to
an additional $16.0 million in the aggregate upon the achievement
of certain net sales of XERAVA in the United States.
“With two, FDA-approved, innovative therapies for
life-threatening diseases, La Jolla is well-positioned to help
patients in need,” said Larry Edwards, President and Chief
Executive Officer of La Jolla. “By leveraging the stronger platform
that the combined company will provide, we look forward to
increasing patient access to these important medicines.”
About GIAPREZA
GIAPREZA™ (angiotensin II) for injection was approved by the
U.S. Food and Drug Administration (FDA) as a vasoconstrictor
indicated to increase blood pressure in adults with septic or other
distributive shock. GIAPREZA was approved by the European
Commission (EC) for the treatment of refractory hypotension in
adults with septic or other distributive shock who remain
hypotensive despite adequate volume restitution and application of
catecholamines and other available vasopressor therapies. GIAPREZA
mimics the body’s endogenous angiotensin II peptide, which is
central to the renin-angiotensin-aldosterone system, which in turn
regulates blood pressure. Prescribing information for GIAPREZA is
available at www.giapreza.com. The European Summary of Product
Characteristics is available on the EMA website:
www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is
marketed in the U.S. by La Jolla Pharmaceutical Company on behalf
of La Jolla Pharma, LLC, its wholly owned subsidiary.
GIAPREZA Important Safety Information
Contraindications
None.
Warnings and Precautions
There is a potential for venous and arterial thrombotic and
thromboembolic events in patients who receive GIAPREZA. Use
concurrent venous thromboembolism (VTE) prophylaxis.
Adverse Reactions
The most common adverse reactions that were reported in greater
than 10% of GIAPREZA-treated patients were thromboembolic
events.
Drug Interactions
Angiotensin converting enzyme (ACE) inhibitors may increase
response to GIAPREZA. Angiotensin II receptor blockers (ARBs) may
reduce response to GIAPREZA.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
For additional information, please see Full Prescribing
Information for the United States and the Summary of Product
Characteristics for the European Union.
About XERAVA
XERAVA™ (eravacycline) for injection was approved by the U.S.
Food and Drug Administration (FDA) as a novel fluorocycline of the
tetracycline class antibacterials 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 Tetraphase'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. Prescribing
information for XERAVA is available at www.xerava.com. XERAVA is
marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly
owned subsidiary of La Jolla.
XERAVA 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, tetracycline-class antibacterial
drugs or to any of the excipients. 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, 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 blood urea
nitrogen, 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.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
For additional information, please see Full Prescribing
Information for the United States.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to the development
and commercialization of innovative therapies that improve outcomes
in patients suffering from life-threatening diseases. GIAPREZA™
(angiotensin II) is approved by the U.S. FDA as a vasoconstrictor
indicated to increase blood pressure in adults with septic or other
distributive shock. XERAVA™ (eravacycline) is approved by the
U.S. FDA for the treatment of complicated intra-abdominal
infections. For more information, please visit www.ljpc.com.
Forward-looking Statements
This press release contains “forward-looking statements” as
defined by the Private Securities Litigation Reform Act of 1995. We
caution investors that forward-looking statements are based on
management’s expectations and assumptions as of the date of this
press release and involve substantial risks and uncertainties that
could cause the actual outcomes to differ materially from what we
currently expect. These risks and uncertainties include, but are
not limited to, those associated with: GIAPREZA™ (angiotensin II)
and XERAVA™ (eravacycline) sales; whether La Jolla will
realize the benefits from the acquisition of Tetraphase
Pharmaceuticals, Inc.; regulatory actions relating to La Jolla’s
products by the U.S. FDA, European Commission and/or other
regulatory authorities; cash used in operating activities and our
capital requirements; and other risks and uncertainties identified
in our filings with the U.S. Securities and Exchange Commission.
Forward-looking statements in this press release apply only as of
the date made, and we undertake no obligation to update or revise
any forward-looking statements to reflect subsequent events or
circumstances.
La Jolla Pharmaceutical Company Contact:Michael
HearneChief Financial OfficerLa Jolla Pharmaceutical Company(858)
333-5769mhearne@ljpc.com
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