La Jolla Pharmaceutical Company Announces Exclusive Worldwide License Agreements Covering LJPC-30Sa and LJPC-30Sb
August 05 2015 - 8:00AM
Business Wire
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, today announced that it has signed
two exclusive worldwide license agreements for the intellectual
property rights covering La Jolla’s next-generation gentamicin
derivatives, LJPC-30Sa and LJPC-30Sb. The first license agreement
is with the Indiana University Research and Technology Corporation
(IURTC), and the second is with the IURTC and the University of
Alabama at Birmingham (UAB). The license agreements, which follow
from the previously announced option agreements, cover the use of
LJPC-30Sa and LJPC-30Sb as antimicrobial agents and for the
potential treatment of rare genetic disorders.
Despite kidney toxicity, gentamicin has become one of the most
commonly prescribed hospital antibiotics due to its broad spectrum
of antimicrobial efficacy. Gentamicin consists primarily of a
mixture of four distinct but closely related chemical entities that
may contribute differentially to the product’s toxicity profile.
LJPC-30Sa and LJPC-30Sb are purified components of the currently
marketed gentamicin product that retain the biologic activity of
gentamicin, yet appear to lack the traditional kidney toxicity
associated with it.
La Jolla plans to pursue a dual development strategy with its
next-generation gentamicin derivative program. Specifically, La
Jolla plans to develop LJPC-30Sa and LJPC-30Sb not only for the
potential treatment of serious bacterial infections but also for
the potential treatment of rare genetic disorders, such as cystic
fibrosis and Duchenne muscular dystrophy. Following a
pre-Investigational New Drug Application (IND) meeting with the
U.S. Food and Drug Administration (FDA), La Jolla has received
guidance that it may proceed with a proposed Phase 1 clinical trial
following the submission of an IND.
“We are delighted by the continued progress of our
next-generation gentamicin derivative program with our colleagues
at IURTC and UAB,” said George Tidmarsh, M.D., Ph.D., President and
Chief Executive Officer of La Jolla. “Following a positive pre-IND
meeting with the FDA, we look forward to further advancing this
program with the filing of an IND followed by the commencement of a
Phase 1 clinical trial.”
About LJPC-30Sa and LJPC-30Sb
LJPC-30Sa and LJPC-30Sb are La Jolla’s next-generation
gentamicin derivatives. Despite kidney toxicity, gentamicin has
become one of the most commonly prescribed hospital antibiotics due
to its broad spectrum of antimicrobial efficacy. Gentamicin
consists primarily of a mixture of four distinct but closely
related chemical entities that may contribute differentially to the
product’s toxicity profile.
LJPC-30Sa and LJPC-30Sb are purified components of the currently
marketed gentamicin product that retain the biologic activity of
gentamicin, yet appear to lack the traditional kidney toxicity
associated with it. La Jolla is developing LJPC-30Sa and LJPC-30Sb
not only for the potential treatment of serious bacterial
infections but also for the potential treatment of rare genetic
disorders, such as cystic fibrosis and Duchenne muscular
dystrophy.
La Jolla believes that gentamicin’s ability to induce a lack of
fidelity in gene transcription, intrinsic to its antimicrobial
mechanism of action, can also be leveraged in the correction of
certain human genetic mutations that lead to rare genetic
disorders, such as cystic fibrosis and Duchenne muscular dystrophy.
In spite of favorable short-term clinical proof-of-efficacy data in
cystic fibrosis, development of gentamicin as a chronic treatment
for these genetic diseases has been limited by its toxicity
profile.
Following a pre-Investigational New Drug Application (IND)
meeting with the U.S. Food and Drug Administration (FDA), La Jolla
has received guidance that it may proceed with a proposed Phase 1
clinical trial following the submission of an IND.
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
several product candidates in development. LJPC-501 is La Jolla's
proprietary formulation of angiotensin II for the potential
treatment of catecholamine-resistant hypotension. LJPC-401 is La
Jolla's novel formulation of hepcidin for the potential treatment
of conditions characterized by iron overload, such as hereditary
hemochromatosis and beta thalassemia. LJPC-30Sa and LJPC-30Sb are
La Jolla's next-generation gentamicin derivatives for the potential
treatment of serious bacterial infections and rare genetic
disorders, such as cystic fibrosis and Duchenne muscular dystrophy.
For more information on La Jolla, please visit www.ljpc.com.
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 future events or the Company’s future
results of operations. These statements are only predictions and
involve known and unknown risks, uncertainties and other factors,
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 relating to: the timing for the filing of an
Investigational New Drug Application, commencement of clinical
studies and the anticipated timing for completion of such studies;
the success of future development activities for LJPC-501,
LJPC-401, LJPC-30Sa and LJPC-30Sb; potential indications for which
LJPC-501, LJPC-401, LJPC-30Sa and LJPC-30Sb may be developed; the
potential market sizes for our product candidates in development;
and any future success in out-licensing or partnering GCS-100 or
LJPC-1010. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150805005559/en/
La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive
Officer858-207-4264gtidmarsh@ljpc.comandDennis M. MulroyChief
Financial Officer858-433-6839dmulroy@ljpc.com
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