La Jolla Pharmaceutical Company Announces Notice of Allowance for U.S. Patent Covering LJPC-501
November 30 2015 - 8:00AM
Business Wire
Patent Term Extends to 2034
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 the issuance of a
Notice of Allowance from the United States Patent and Trademark
Office (USPTO) for U.S. patent application number 14/575,127,
entitled “Angiotensin II Alone or in Combination for the Treatment
of Hypotension,” which covers LJPC-501, La Jolla’s proprietary
formulation of angiotensin II for the potential treatment of
catecholamine-resistant hypotension (CRH). LJPC-501 is currently
the subject of a Phase 3 clinical trial for the treatment of CRH,
and results from this trial are expected by the end of 2016.
La Jolla has an exclusive license to this patent application
from the George Washington University, and the resulting patent
will have a term extending to 2034. This Notice of Allowance
concludes substantive examination of the patent application and
will result in the issuance of a U.S. patent after administrative
processes are completed. Additional claims are being pursued in a
continuation application.
“This newly allowed patent covering LJPC-501 is a valuable
addition to La Jolla’s intellectual property portfolio,” said
George F. Tidmarsh, M.D., Ph.D., President and CEO of La Jolla. “We
believe that LJPC-501 has the potential to reverse acute
hypotension in critically ill patients and, therefore, provide a
significant benefit to patients suffering from CRH.”
About LJPC-501
LJPC-501 is La Jolla’s proprietary formulation of angiotensin
II. Angiotensin II, the major bioactive component 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 (CRH), which
is an acute, life-threatening condition in which blood pressure
drops to dangerously low levels in patients who respond poorly to
current treatments. Angiotensin II has been shown to raise blood
pressure in a randomized, placebo-controlled clinical trial in CRH,
which was recently published in the journal Critical Care, as well
as in animal models of hypotension. Preclinical pharmacology
studies that La Jolla has conducted have demonstrated that
catecholamine resistance may be in part a result of reduced
endogenous production of angiotensin II. In October 2014, La Jolla
presented positive data from a preclinical study of LJPC-501 for
the treatment of CRH.
La Jolla initiated a Phase 3 clinical trial with LJPC-501 for
the treatment of CRH, called the ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 trial, in March 2015. In February
2015, La Jolla reached agreement with the U.S. Food and Drug
Administration (FDA) on a Special Protocol Assessment (SPA) for
this multicenter, randomized, double-blind, placebo-controlled,
Phase 3 clinical trial. In accordance with the SPA, the primary
efficacy endpoint for the ATHOS 3 registration trial is increase in
blood pressure at three hours. The ATHOS 3 trial is designed to
enroll approximately 315 patients. Patients are to be randomized in
a 1:1 fashion to receive either: (i) LJPC-501 plus standard-of-care
vasopressors; or (ii) placebo plus standard-of-care vasopressors.
Randomized patients are to receive their assigned treatment via
continuous IV infusion for up to seven days. The primary efficacy
endpoint in the study is to compare the change in mean arterial
pressure in patients with CRH who receive an IV infusion of
LJPC-501 plus standard-of-care vasopressors to those that receive
placebo plus standard-of-care vasopressors. Secondary endpoints
include comparison of changes in Cardiovascular Sequential Organ
Failure Assessment, or SOFA scores, and the safety and tolerability
of LJPC-501 in patients with CRH. Results from ATHOS 3 are expected
by the end of 2016.
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, beta thalassemia and sickle cell disease.
LJPC-30Sa and LJPC-30Sb are 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 www.sec.gov. These risks include, but
are not limited to, risks relating to: the timing for commencement
of clinical studies, the anticipated timing for completion of such
studies, and the anticipated timing for regulatory actions; 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; events that
could interfere with the issuance of a patent, or once issued, the
continued validity or enforceability of a patent; the Company's
ability generally to maintain adequate patent protection and
successfully enforce patent claims against third parties; and the
expected duration over which the Company’s cash balances will fund
its operations. 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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La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive
Officer858-207-4264gtidmarsh@ljpc.comorDennis M. MulroyChief
Financial Officer858-433-6839dmulroy@ljpc.com
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