- Allowed claims cover an individualized flat-dosed pharmacodynamic
treatment protocol utilized in the AURA-LV study and the ongoing
AURORA study in lupus nephritis
- Claims have the potential to protect voclosporin’s method of use
and dosing protocol for LN until December 2037
Company Website:
http://www.auriniapharma.com
VICTORIA, British Columbia -- (Business Wire)
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/ TSX:AUP) (the “Company” or
“Aurinia”), a clinical stage biopharmaceutical company focused on the
global immunology market, today announced that it has received a Notice
of Allowance from the United States Patent and Trademark Office
(“USPTO”) for U.S. patent application 15/835,219, entitled “PROTOCOL FOR
TREATMENT OF LUPUS NEPHRITIS”. The allowed claims broadly cover the
novel voclosporin dosing protocol adhered to and required in both the
previously reported Phase II AURA-LV study and the ongoing Phase III
confirmatory AURORA study. Notably, the allowed claims cover a method of
modifying the dose of voclosporin in patients with lupus nephritis (LN)
based on patient specific pharmacodynamic parameters.
This Notice of Allowance concludes a substantive examination of the
patent application at the USPTO, and after administrative processes are
completed and fees are paid, is expected to result in the issuance of a
U.S. patent with a term extending to December 2037. Issuance of the
patent will expand the scope of intellectual property protection for
voclosporin, which already includes robust manufacturing, formulation,
synthesis and composition of matter patents.
The Company has also filed for protection of this subject matter under
the Patent Cooperation Treaty (PCT) and has the option of applying for
similar protection in the member countries thereof. This may lead to the
granting of corresponding claims in the treaty countries which include
all the major global pharmaceutical markets. “These method of use claims
allowed in the U.S. broadly cover the personalized voclosporin dosing
protocol utilized across our LN program, which includes specific dose
modification requirements that we anticipate being incorporated into any
potential future label for voclosporin in LN,” said Michael R. Martin,
Chief Operating Officer of Aurinia.
“This Notice of Allowance is a significant milestone for Aurinia as it
enhances our current intellectual property portfolio and provides
potential exclusivity for Aurinia’s protocol for the treatment of
proteinuric kidney diseases, including LN, until late 2037. Importantly,
these claims provide validation of some unique and differentiating
features of voclosporin compared to the legacy CNIs.” stated Richard M.
Glickman, Chairman and CEO of Aurinia. “Establishing a robust
exclusivity platform is a critical part of our strategy as we work
towards regulatory approvals in the United States and internationally.”
About Aurinia
Aurinia Pharmaceuticals Inc. is a clinical stage biopharmaceutical
company focused on developing and commercializing therapies to treat
targeted patient populations that are suffering from serious diseases
with a high unmet medical need. The company is currently developing voclosporin,
an investigational drug, for the potential treatment of lupus nephritis
(LN), focal segmental glomerulosclerosis (FSGS), and dry eye syndrome
(DES). The company is headquartered in Victoria, British Columbia and
focuses its development efforts globally. For further information, see
our website at www.auriniapharma.com.
About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially
best-in-class CNI with clinical data in over 2,400 patients across
indications. Voclosporin is an immunosuppressant, with a synergistic and
dual mechanism of action. By inhibiting calcineurin, voclosporin blocks
IL-2 expression and T-cell mediated immune responses and stabilizes the
podocyte in the kidney. It has been shown to have a more predictable
pharmacokinetic and pharmacodynamic relationship (potentially requires
no therapeutic drug monitoring), an increase in potency (vs
cyclosporin), and an improved metabolic profile compared to legacy CNIs.
Aurinia anticipates that upon regulatory approval, patent protection for
voclosporin’s composition of matter will be extended in the United
States and certain other major markets, including Europe and Japan,
until at least October 2027 under the Hatch-Waxman Act and comparable
laws in other countries and until April 2028 with anticipated pediatric
extension. Voclosporin’s unique dosing protocol used in both the AURA-LV
and the AURORA studies for LN has also been granted a Notice of
Allowance from the USPTO, these allowed claims have the potential to
provide additional coverage for voclosporin until late 2037.
About Lupus Nephritis (LN)
LN in an inflammation of the kidney caused by Systemic Lupus
Erythematosus (“SLE”) and represents a serious progression of SLE. SLE
is a chronic, complex and often disabling disorder. The disease is
highly heterogeneous, affecting a wide range of organs & tissue systems.
Unlike SLE, LN has straightforward disease outcomes (measuring
proteinuria) where an early response correlates with long-term outcomes.
In patients with LN, renal damage results in proteinuria and/or
hematuria and a decrease in renal function as evidenced by reduced
estimated glomerular filtration rate (“eGFR”), and increased serum
creatinine levels. LN is debilitating and costly and if poorly
controlled, LN can lead to permanent and irreversible tissue damage
within the kidney, resulting in end-stage renal disease (“ESRD”), thus
making LN a serious and potentially life-threatening condition.
Forward-Looking Statements
Certain statements made in this press release may constitute
forward-looking information within the meaning of applicable Canadian
securities law and forward-looking statements within the meaning of
applicable United States securities law. These forward-looking
statements or information include but are not limited to statements or
information with respect to: the USPTO granting a new patent for the
Company’s protocol with LN; the new patent having a patent term
extending to 2037; Aurinia’s new patent claims being listed in the FDA’s
Orange book; filings with the PCT leading to the granting of
corresponding claims in treaty countries; voclosporin being potentially
a best-in-class CNI with robust intellectual property exclusivity; the
patent life for Aurinia’s patents; and the potential to extend that
patent life on the occurrence of certain events. It is possible that
such results or conclusions may change based on further analyses of
these data. Words such as “anticipate”, “will”, “believe”, “estimate”,
“expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and
other similar words and expressions, identify forward-looking
statements. We have made numerous assumptions about the forward-looking
statements and information contained herein, including among other
things, assumptions about: that another company will not create a
substantial competitive product without violating Aurinia’s intellectual
property rights; that the FDA will grant Aurinia approval for use of
voclosporin with LN; that voclosporin in LN would qualify for
publication in the FDA’s Orange Book; that the USPTO will issue a new
patent once applicable steps have been followed and fees paid in respect
of the Notice of Allowance; and Aurinia being able to extend its patents
on terms acceptable to Aurinia. Even though the management of Aurinia
believes that the assumptions made, and the expectations represented by
such statements or information are reasonable, there can be no assurance
that the forward-looking information will prove to be accurate.
Forward-looking information by their nature are based on assumptions and
involve known and unknown risks, uncertainties and other factors which
may cause the actual results, performance or achievements of Aurinia to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking information.
Should one or more of these risks and uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those described in forward-looking statements or
information. Such risks, uncertainties and other factors include, among
others, the following: difficulties, delays, or failures we may
experience in the conduct of our AURORA clinical trial; the FDA may not
approve voclosporin for use with LN or for any other purpose; Aurinia
not being able to extend or protect its patent portfolio for voclosporin
or VOS; and competitors may arise with similar or more competitive
products. Although we have attempted to identify factors that would
cause actual actions, events or results to differ materially from those
described in forward-looking statements and information, there may be
other factors that cause actual results, performances, achievements or
events to not be as anticipated, estimated or intended. Also, many of
the factors are beyond our control. There can be no assurance that
forward-looking statements or information will prove to be accurate, as
actual results and future events could differ materially from those
anticipated in such statements. Accordingly, you should not place undue
reliance on forward-looking statements or information.
Except as required by law, Aurinia will not update forward-looking
information. All forward-looking information contained in this press
release is qualified by this cautionary statement. Additional
information related to Aurinia, including a detailed list of the risks
and uncertainties affecting Aurinia and its business can be found in
Aurinia’s most recent Annual Information Form available by accessing the
Canadian Securities Administrators’ System for Electronic Document
Analysis and Retrieval (SEDAR) website at www.sedar.com
or the U.S. Securities and Exchange Commission’s Electronic Document
Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190225005194/en/
Contacts:
Aurinia Pharmaceuticals
Investor Contact:
Michael R. Martin
Chief Operating Officer/Intellectual
Property
mmartin@auriniapharma.com
or
Celia Economides
Vice President, Corporate & Public
Affairs
ceconomides@auriniapharma.com
Media Contact:
Christopher Hippolyte, 212-364-0458
Christopher.Hippolyte@syneoshealth.com
Source: Aurinia Pharmaceuticals Inc.
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