La Jolla Pharmaceutical Company and the George Washington University Announce Exclusive Worldwide License Agreement
December 09 2014 - 4:01PM
Business Wire
License Covers Intellectual Property
Relating to LJPC-501
La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the Company or
La Jolla), a leader in the development of innovative therapies
intended to significantly improve outcomes in patients suffering
from life-threatening diseases, and the George Washington
University (GW), today announced that La Jolla and GW have entered
into an exclusive worldwide license agreement for GW intellectual
property rights covering the use of angiotensin II for the
therapeutic treatment of patients with hypotension and shock. La
Jolla plans to initiate a phase 3 registration program of LJPC-501,
La Jolla’s proprietary formulation of angiotensin II, in
catecholamine-resistant hypotension (CRH) in the first quarter of
2015.
“We are very pleased to gain access to this additional
intellectual property covering LJPC-501,” said George F. Tidmarsh,
M.D., Ph.D., President and CEO of La Jolla. “The prognosis for
patients suffering from CRH is very poor, with less than 50% of
these patients surviving one month from diagnosis. We believe that
LJPC-501 has the potential to reverse hypotension and, therefore,
provide a significant benefit to these patients.”
“Moving this important innovation from GW's School
of Medicine directly to a Phase 3 clinical trial means that
doctors treating hypotension and shock could have better options
relatively soon,” said Steven Kubisen, Director of the GW Office of
Technology Transfer. “La Jolla's expertise with LJPC-501 makes this
partnership well-positioned for success.”
“The discovery of novel therapies to help patients in need is at
the core of the mission of the GW School of Medicine and Health
Sciences. With exceptional research, coupled with La Jolla’s
development expertise, we aim to bring better options to patients
who face life-threatening risks associated with hypotension,” said
Robert Miller, Ph.D., GW’s Senior Associate Dean for Research,
Vivian Gill Distinguished Research Professor and Professor of
Anatomy and Regenerative Biology.
About LJPC-501
LJPC-501 is La Jolla’s proprietary formulation of angiotensin
II. Angiotensin II, the major bioactive product of the
renin-angiotensin system, serves as one of the body’s central
regulators of blood pressure. La Jolla is developing LJPC-501 for
the treatment of catecholamine-resistant hypotension, or CRH, which
is an acute, life-threatening condition in which blood pressure
drops to dangerously low levels and is poorly responsive to current
treatments. Angiotensin II has been shown to raise blood pressure
in a randomized, placebo-controlled clinical trial in CRH, as well
as animal models of hypotension. In October 2014, La Jolla
presented positive data from a preclinical study of LJPC-501 in the
treatment of CRH. In June 2014, La Jolla had a meeting with the
U.S. Food and Drug Administration, or FDA, in which agreement was
reached that blood pressure can be the primary endpoint for
approval in CRH. As a result of this meeting, La Jolla plans to
initiate a Phase 3 registration clinical trial of LJPC-501 in CRH
in the first quarter of 2015. La Jolla believes CRH to be an orphan
indication, and, therefore, in July 2014, La Jolla submitted an
Orphan Drug Designation application to the FDA for LJPC-501 in the
treatment of CRH.
La Jolla is also developing LJPC-501 for hepatorenal syndrome,
or HRS. HRS is a life-threatening form of progressive renal failure
in patients with liver cirrhosis or fulminant liver failure. In
these patients, the diseased liver secretes vasodilator substances
(e.g., nitric oxide and prostaglandins) into the bloodstream that
cause under-filling of blood vessels. This low blood pressure state
causes a reduction in blood flow to the kidneys. As a means to
restore systemic blood pressure, the kidneys induce both sodium and
water retention, which contribute to ascites, a major complication
associated with HRS. Studies have shown that LJPC-501 may improve
renal function in patients with conditions similar to HRS. La Jolla
is currently conducting a Phase 1/2 clinical trial of LJPC-501 in
HRS, and, in August 2014, La Jolla enrolled its first patient in
this trial. The Phase 1/2 clinical trial is currently enrolling
patients.
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. The Company has
four product candidates in development. LJPC-501 is La Jolla’s
proprietary formulation of angiotensin II for the potential
treatment of catecholamine-resistant hypotension (CRH) and
hepatorenal syndrome (HRS). GCS-100 is La Jolla’s first-in-class
galectin-3 inhibitor for the potential treatment of chronic kidney
disease (CKD). LJPC-1010, La Jolla’s second-generation galectin-3
inhibitor, is a more potent and purified derivative of GCS-100 that
can be delivered orally for the potential treatment of nonalcoholic
steatohepatitis (NASH) and other diseases characterized by tissue
fibrosis. LJPC-401 is La Jolla’s novel formulation of hepcidin for
the potential treatment of iron overload. For more information on
La Jolla, please visit www.ljpc.com.
About the George Washington University
In the heart of the nation’s capital, with additional programs
in Virginia, the George Washington University, or GW, was created
by an Act of Congress in 1821. Today, GW is the largest institution
of higher education in the District of Columbia. The university
offers comprehensive programs of undergraduate and graduate liberal
arts study, as well as degree programs in medicine, public health,
law, engineering, education, business and international affairs.
Each year, GW enrolls a diverse population of undergraduate,
graduate and professional students from all 50 states, the District
of Columbia and more than 130 countries.
Forward-Looking Statement Safe Harbor
This document contains “forward-looking statements,” as that
term is defined in the Private Securities Litigation Reform Act of
1995. These statements relate to the Company’s expectations
regarding future events or its future results of operations. These
statements are only predictions and involve known and unknown
risks, uncertainties and other factors, any one of which may cause
actual results to be materially different from these
forward-looking statements. The Company 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
the Company’s filings with the U.S. Securities and Exchange
Commission (SEC), all of which are available free of charge on the
SEC’s web site http://www.sec.gov. These risks include, but
are not limited to, risks and uncertainties relating to: the timing
for the commencement of clinical studies and the anticipated timing
for completion of such studies; whether patent applications
licensed from the George Washington University will result in
issued patents and whether such patents, if issued, would cover
LJPC-501; the success of future development activities for
LJPC-501, GCS-100, LJPC-1010 and LJPC-401; estimated market sizes
and the ability to successfully receive Orphan Drug designation for
LJPC-501; and potential indications for which LJPC-501, GCS-100,
LJPC-1010 and LJPC-401 may be developed. Subsequent written and
oral forward-looking statements attributable to the Company or to
persons acting on its behalf are expressly qualified in their
entirety by the cautionary statements set forth in the Company’s
reports filed with the SEC. The Company expressly disclaims any
intent to update any forward-looking statements.
La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive Officer(858)
207-4264gtidmarsh@ljpc.comorChester S. Zygmont, IIISenior Director
of Finance(858) 207-4262czygmont@ljpc.comorThe George Washington
UniversityEmily GrebensteinMedia Relations Specialist(202)
994-3087emgreb@gwu.edu
La Jolla Pharmaceutical (NASDAQ:LJPC)
Historical Stock Chart
From Mar 2024 to Apr 2024
La Jolla Pharmaceutical (NASDAQ:LJPC)
Historical Stock Chart
From Apr 2023 to Apr 2024