La Jolla Pharmaceutical Company Announces Launch of GIAPREZA™ (angiotensin II) in the United States
March 22 2018 - 4:01PM
La Jolla Pharmaceutical Company (Nasdaq:LJPC) today announced that
GIAPREZA™ (angiotensin II), injection for intravenous
infusion, is now commercially available. In December 2017,
GIAPREZA was approved by the U.S. Food and Drug
Administration (FDA) to increase blood pressure in adults with
septic or other distributive shock. GIAPREZA mimics the body’s
endogenous regulatory peptide that is central to the
renin-angiotensin-aldosterone system to increase blood pressure.
GIAPREZA is available in 1 mL single-dose vials, each containing
2.5 mg of angiotensin II (as a sterile liquid). Prescribing
information for GIAPREZA is available at www.giapreza.com.
GIAPREZA Authorized Distributors
GIAPREZA will be distributed to hospitals through a network of
authorized specialty distributors, including:
- ASD Specialty Healthcare, LLC, a subsidiary of
AmerisourceBergen Corporation
- Cardinal Health Specialty Pharmaceutical Distribution, a part
of Cardinal Health, Inc.
- McKesson Plasma and Biologics, LLC, a part of McKesson
Corporation
About Septic or Other Distributive Shock
Over 1 million Americans are affected by shock on an annual
basis, with 1 in 3 patients being treated for shock in the
intensive care unit. Distributive shock is the most common type of
shock in the inpatient setting with approximately 800,000
distributive shock cases in the U.S. per year. Of these cases, an
estimated 90% are septic shock patients. Approximately 300,000 do
not achieve adequate blood pressure response with standard of care
vasopressor therapy (catecholamines and vasopressin). The inability
to achieve or maintain adequate blood pressure results in
inadequate blood flow to the body’s organs and tissues and is
associated with a mortality rate exceeding most acute conditions
requiring hospitalization.
About GIAPREZA
In December 2017, GIAPREZA™ (angiotensin II) was approved
by the U.S. Food and Drug Administration (FDA) to
increase blood pressure in adults with septic or other distributive
shock. GIAPREZA mimics the body’s endogenous regulatory peptide
that is central to the renin-angiotensin-aldosterone system to
increase blood pressure. Prescribing information for GIAPREZA is
available at www.giapreza.com.
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 reported in greater than 10%
in GIAPREZA treated patients were thromboembolic events.
Drug Interactions
Angiotensin converting enzyme (ACE) inhibitors may increase
response to GIAPREZA.Angiotensin II receptor blockers (ARB) 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.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical
company focused on the discovery, development and commercialization
of innovative therapies intended to significantly improve outcomes
in patients suffering from life-threatening diseases.
GIAPREZA™ (angiotensin II), formerly known as LJPC-501, was
approved by the U.S. Food and Drug Administration
(FDA) on December 21, 2017 as a vasoconstrictor to
increase blood pressure in adults with septic or other distributive
shock. LJPC‑401 (synthetic human hepcidin), a clinical-stage
investigational product, is being developed for the potential
treatment of conditions characterized by iron overload, such as
hereditary hemochromatosis, beta thalassemia, sickle cell disease
and myelodysplastic syndrome. For more information, please
visit www.ljpc.com.
Forward-looking Statements
This press release contains forward-looking statements, as that
term is defined in the Private Securities Litigation Reform Act of
1995. These statements relate to expectations regarding future
events or La Jolla’s future results of operations. These statements
are only predictions or statements of current expectations and
involve known and unknown risks, uncertainties and other factors
that may cause actual results to be materially different from those
anticipated by the forward-looking statements. La Jolla cautions
readers not to place undue reliance on any such forward-looking
statements, which speak only as of the date they were made. Certain
of these risks, uncertainties and other factors are described in
greater detail in La Jolla’s filings with the U.S. Securities and
Exchange Commission (SEC), all of which are available free of
charge on the SEC’s website www.sec.gov. These risks include,
but are not limited to, risks relating to: unforeseen safety issues
from the administration of GIAPREZA in patients; potential market
sizes, including for septic or other distributive shock; our
ability to successfully commercialize, market and achieve market
acceptance of GIAPREZA; and other risks and uncertainties
identified in our filings with the SEC. La Jolla expressly
disclaims any intent to update any forward‑looking statements to
reflect the outcome of subsequent events.
Company Contacts
Sandra VedrickDirector, Investor Relations & Human
ResourcesLa Jolla Pharmaceutical CompanyPhone: (858) 207-4264 Ext:
1135Email: svedrick@ljpc.com
and
Dennis M. MulroyChief Financial OfficerLa Jolla Pharmaceutical
CompanyPhone: (858) 207-4264 Ext: 1040Email: dmulroy@ljpc.com
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