La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is
dedicated to the commercialization of innovative therapies that
improve outcomes in patients suffering from life-threatening
diseases, today announced the appointment of Tony Hodges, M.D.,
FACP, FCCP, as Chief Medical Officer.
“We are thrilled to have Tony join our team here at La Jolla,”
said Larry Edwards, President and Chief Executive Officer of La
Jolla. “Tony’s clinical experience, operational leadership and
in-depth knowledge of critical care medicine are key to helping La
Jolla grow net sales of GIAPREZA and XERAVA and become a leader in
the critical care space.”
“I look forward to working with the La Jolla team to continue to
expand patient access to GIAPREZA and XERAVA,” said Tony Hodges,
M.D., FACP, FCCP, Chief Medical Officer of La Jolla. “I am grateful
to have the opportunity to join a company that focuses on improving
outcomes in patients suffering from life-threatening diseases.”
From 2016 to 2020, Dr. Hodges served in various positions at
Banner—University Medical Center Phoenix, including serving as
Director of the Center for Lung Transplantation, Director of the
Center for Infusion Medicine and Physician Executive Director of
Revenue Cycle Operations. From 2006 to 2012, he was Co-founder and
Director of the Center for Thoracic Transplantation and Medical
Director of Lung Transplant at the Norton Thoracic Institute at St.
Joseph’s Hospital and Medical Center in Phoenix, Arizona. From 2002
to 2006, Dr. Hodges served as Medical Director of the Lung
Transplantation and Advanced Lung Disease Center at Keck University
of Southern California Hospital. He completed his Pulmonary and
Critical Care and Lung Transplant Fellowships at the University of
Colorado Health Sciences Center and was Associate Director of Lung
Transplantation at the University of Colorado. Dr. Hodges is an
internationally recognized expert in the areas of organ failure,
advanced lung diseases, transplantations and infectious
complications of the immunocompromised host.
About GIAPREZA
GIAPREZA™ (angiotensin II) injection is 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 is 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 at 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, and
is marketed in Europe by PAION Deutschland GmbH on behalf of La
Jolla Pharma, LLC.
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 is approved by the U.S.
Food and Drug Administration (FDA) as a tetracycline class
antibacterial indicated for the treatment of complicated
intra-abdominal infections (cIAI) in patients 18 years of age and
older. XERAVA is approved by the European Commission (EC) for the
treatment of cIAI in adults. Prescribing information for XERAVA is
available at www.xerava.com. The European Summary of Product
Characteristics is available at
www.ema.europa.eu/en/medicines/human/EPAR/xerava. XERAVA is
marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly
owned subsidiary of La Jolla, and is marketed in Europe by PAION
Deutschland GmbH on behalf of Tetraphase Pharmaceuticals, Inc.
Everest, the Company’s licensee for mainland China, Taiwan, Hong
Kong, Macau, South Korea, Singapore, the Malaysian Federation, the
Kingdom of Thailand, the Republic of Indonesia, the Socialist
Republic of Vietnam and the Republic of the Philippines, submitted
an NDA in China, which was accepted by the China National Medical
Products Administration (NMPA) in March 2021.
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
commercialization of innovative therapies that improve outcomes in
patients suffering from life-threatening diseases. GIAPREZA™
(angiotensin II) injection is approved by the FDA as a
vasoconstrictor indicated to increase blood pressure in adults with
septic or other distributive shock. XERAVA™ (eravacycline) for
injection is approved by the FDA as a tetracycline class
antibacterial indicated for the treatment of complicated
intra-abdominal infections (cIAI) in patients 18 years of age and
older. 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; operating costs; regulatory
actions relating to La Jolla’s products by the U.S. FDA, European
Commission, China National Medical Products Administration and/or
other regulatory authorities; expected future cash flows of La
Jolla, including upfront, milestone, royalty and other payments
resulting from La Jolla’s out-license agreements and commercial
supply agreements; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210910005119/en/
La Jolla Pharmaceutical Company Contact Michael Hearne Chief
Financial Officer La Jolla Pharmaceutical Company (617) 715-3598
mhearne@ljpc.com
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