La Jolla Pharmaceutical Company Announces FDA Approval of Giapreza™ (angiotensin II)
December 21 2017 - 6:15PM
Giapreza increases blood pressure in adults with
septic or other distributive shock
La Jolla Pharmaceutical Company (Nasdaq:LJPC) (the Company or La
Jolla) today announced that the U.S. Food and Drug Administration
(FDA) has approved GiaprezaTM (angiotensin II) to increase blood
pressure in adults with septic or other distributive shock.
“We appreciate FDA’s rapid review and approval of Giapreza and
are especially grateful to the patients, families and dedicated
critical care teams who made the development of Giapreza possible,”
said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive
Officer of La Jolla. “We look forward to bringing this new
treatment option to the many critically ill patients suffering from
septic or other distributive shock.”
“Vasopressors are critical to treat patients with shock. The
critical care community now has another tool to use,” said John A.
Kellum, M.D., Director of Center for Critical Care Nephrology, Vice
Chair for Research, and Professor of Critical Care Medicine,
University of Pittsburgh. “The approval of angiotensin II
represents a major advance in the treatment of patients with septic
or distributive shock.”
La Jolla plans to make Giapreza available for patients in the
U.S. in March 2018. Prescribing information for Giapreza is
available at www.giapreza.com.
About Septic or Other Distributive Shock
Distributive shock is the most common type of shock in the
inpatient setting, affecting approximately one-third of intensive
care unit patients. There are approximately 800,000 distributive
shock cases in the United States per year. Of these cases, an
estimated 90% are septic shock patients. Approximately 300,000 do
not achieve adequate blood pressure response with current standard
therapy. The inability to achieve or maintain adequate blood
pressure results in inadequate blood flow to the body’s organs and
tissue and is associated with a mortality rate exceeding most acute
conditions requiring hospitalization.
Conference Call at 8:30 a.m. Eastern Time on December
22, 2017
The Company will host a conference call and webcast at 8:30 a.m.
Eastern Time (5:30 a.m. Pacific Time) on December 22, 2017. The
conference call can be accessed by dialing 877‑359‑9508 for
domestic callers and 224‑357‑2393 for international callers. Please
provide the operator with the passcode 7979625 to join the
conference call or click here for the webcast. A slide presentation
accompanying today’s press release and the conference call may also
be found on La Jolla’s website at www.ljpc.com thirty minutes prior
to the call under the investor relations section. An archive of the
conference call and webcast will be available on La Jolla’s website
for 30 days following the call.
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 in December 2017 as a
vasoconstrictor to increase blood pressure in adults with septic or
other distributive shock. La Jolla plans to make Giapreza available
for patients in the U.S. starting in March 2018. LJPC‑401
(synthetic human hepcidin) 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 on La Jolla,
please visit www.ljpc.com.
Forward Looking Statement Safe Harbor
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: the timing for
commercial launch of Giapreza (angiotensin II); the degree of
physician or pharmacy and therapeutics committee adoption of
Giapreza and La Jolla’s success in commercializing Giapreza; the
timing and availability of Giapreza in the market; the anticipated
treatment of future clinical data by the FDA, the EMA or other
regulatory authorities, including whether such data will be
sufficient for approval of Giapreza in the EMA and for approval of
other product candidates by either the FDA or EMA; risks relating
to the scope of the Giapreza product label; potential market sizes,
including for septic or other distributive shock; potential
indications for which La Jolla’s products and product candidates
may be developed; the anticipated timing for regulatory actions;
the timing, costs, conduct and outcome of clinical studies; the
impact of pharmaceutical industry regulation and healthcare
legislation in the United States; and the success of future
development activities. 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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