La Jolla to receive upfront cash payment of
$22.5 million plus potential commercial milestone payments of up to
$109.5 million and double-digit tiered royalty payments
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, today announced that it and certain of
its wholly owned subsidiaries (collectively, La Jolla) have entered
into an exclusive licensing agreement with PAION AG and its wholly
owned subsidiary (PAION) for GIAPREZA™ (angiotensin II) and XERAVA™
(eravacycline) in the European Economic Area, the United Kingdom
and Switzerland (the Territories).
Under the terms of the exclusive licensing agreement, La Jolla
will be entitled to receive: (i) an upfront cash payment of $22.5
million; (ii) potential commercial milestone payments of up to
$109.5 million; and (iii) double-digit tiered royalty payments
based on net sales of GIAPREZA and XERAVA. In exchange, La Jolla
granted PAION an exclusive license to commercialize GIAPREZA and
XERAVA in the Territories.
GIAPREZA is approved by the European Commission as a
vasoconstrictor indicated 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. XERAVA is approved by the European Commission for the
treatment of complicated intra-abdominal infections in adults.
“Our agreement with PAION marks an important step in our global
strategic plans to bring innovative therapies that improve outcomes
in patients suffering from life-threatening diseases to Europe,”
said Larry Edwards, President and Chief Executive Officer of La
Jolla. “We are excited to have PAION as a partner and expect its
commercialization expertise will be invaluable in maximizing the
value of GIAPREZA and XERAVA in Europe.”
“We are excited to add these attractive hospital products to our
portfolio, giving us a strong basis to launch our European
commercial organization and to build out our sales and marketing
activities,” said Dr. Jim Phillips, Chief Executive Officer of
PAION AG. “We will be using single, hospital focused sales teams in
each country to commercialize these products in Europe. The
licensing agreement announced today puts us on strong footing to
become a leading specialty pharmaceutical company in the fields of
anaesthesia and critical care.”
About GIAPREZA
GIAPREZA™ (angiotensin II) for 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
http://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, and will be
marketed in Europe by PAION AG 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 a novel fluorocycline of
the tetracycline class of antibacterials that is approved by the
U.S. Food and Drug Administration (FDA) 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. XERAVA is marketed in the U.S. by
Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La
Jolla, and will be marketed in Europe by PAION AG on behalf of
Tetraphase Pharmaceuticals, Inc.
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; regulatory actions relating to La
Jolla’s products by the U.S. FDA, European Commission and/or other
regulatory authorities; the expected future cash flows, including
any upfront, milestone and/or royalty payments, resulting from La
Jolla’s exclusive license agreement with PAION AG and its wholly
owned subsidiary; 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/20210112005460/en/
Michael Hearne Chief Financial Officer La Jolla Pharmaceutical
Company (858) 333-5769 mhearne@ljpc.com
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