La Jolla Pharmaceutical Company Acquires Rights to Next-Generation Gentamicin Derivatives
May 07 2015 - 4:17PM
Business Wire
Conference Call and Webcast at 8:00 AM Eastern
Time on Friday, May 8
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 entered
into an exclusive option agreement to acquire the Indiana
University Research and Technology Center’s (IURTC) intellectual
property rights covering next-generation gentamicin derivatives.
Gentamicin has become one of the most commonly prescribed hospital
antibiotics, despite causing kidney toxicity. Gentamicin consists
of a mixture of distinct but closely related chemical entities that
may contribute differentially to the product’s toxicity profile.
IURTC’s technology covers the use of next-generation, parenteral
gentamicin derivatives as antimicrobial agents with the potential
for reduced toxicity.
La Jolla also entered into a second option agreement with IURTC
and the University of Alabama at Birmingham (UAB) for the use of
these next-generation compounds for the treatment of certain rare
genetic diseases, such as cystic fibrosis and Duchenne muscular
dystrophy. Gentamicin’s ability to induce a lack of fidelity in
gene transcription, intrinsic to its antimicrobial mechanism of
action, can be leveraged in the correction of certain human genetic
mutations that lead to rare genetic disorders. 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.
La Jolla has initially selected two lead development candidates
from the technology, LJPC-30Sa and LJPC-30Sb, which are purified
components of the currently marketed gentamicin product. LJPC-30Sa
and LJPC-30Sb 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 in serious
bacterial infections and rare genetic disorders characterized by
stop codon mutations, 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, La Jolla
has received guidance that it may proceed with its proposed Phase 1
clinical trial following the submission of an IND.
“We are very pleased to gain access to this intellectual
property covering next-generation gentamicin derivatives,” said
George F. Tidmarsh, M.D., Ph.D., President and Chief Executive
Officer of La Jolla. “The use of aminoglycoside antibiotics has
been limited primarily by treatment-related toxicity. We believe
that our next-generation gentamicin derivatives may retain the
activity of gentamicin, but improve the therapeutic window, thereby
improving the outcome for patients requiring antimicrobial agents
and potentially creating new opportunities for the treatment of
rare genetic disorders.”
Conference Call and Webcast
The Company will hold an investor conference call and webcast at
8:00 AM Eastern Time/5:00 AM Pacific Time on Friday, May 8, 2015.
You can participate on the call by either dialing (877) 359-9508
pin: 44727023 or click here for the webcast.
About Gentamicin and Aminoglycoside Antibiotics
Gentamicin is an FDA-approved aminoglycoside antibiotic that is
commonly used in infections in pregnancy and end-stage renal
disease, urinary tract infections, endocarditis, serious
Staphylococcus infections, and a wide range of other infections.
Aminoglycosides are a broad-spectrum class of Gram-negative
antibiotics that are a mainstay in the hospital setting. They are
also used to potentiate the activity of certain classes of
Gram-positive antibiotics. The use of the aminoglycoside class has
increased over the last 10 years due to its broad spectrum activity
against resistant bacteria, concentration-dependent killing, and
prolonged duration of action, but its usage has been limited by
dose-dependent and cumulative kidney toxicity and ototoxicity,
which is toxicity to the ear. Current prescription data for
aminoglycosides as antimicrobial agents represent over a $500
million market opportunity in the U.S., adjusted for branded
pricing of comparable hospital antimicrobials.
A product manufactured through fermentation, gentamicin consists
of a mixture of distinct but closely related chemical entities.
While these distinct chemical entities appear to all retain
antimicrobial activity, they may contribute differentially to
toxicity. In particular, gentamicin’s kidney toxicity appears to be
associated with some but not all of its constituent chemical
entities. A gentamicin derivative that retains antimicrobial
activity but had reduced kidney toxicity would represent a major
advance for patients.
Gentamicin’s ability to induce a lack of fidelity in gene
transcription, intrinsic to its antimicrobial mechanism of action,
can 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 currently marketed gentamicin as a chronic treatment
for these genetic diseases has been limited by its toxicity
profile.
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 and hepatorenal
syndrome. LJPC-401 is La Jolla’s novel formulation of hepcidin for
the potential treatment of conditions characterized by iron
overload, such as 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.
La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive Officer(858)
207-4264gtidmarsh@ljpc.comandDennis M. MulroyChief Financial
Officer(858) 433-6839dmulroy@ljpc.com
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