VICTORIA, British Columbia–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the
“Company”), a clinical stage biopharmaceutical company focused on the
global immunology market, today announced it has appointed Dr. Daniel
Billen to its Board of Directors. Dr. Billen’s appointment is effective
April 29, 2019 concurrent with the previously announced appointment of
Mr. Peter Greenleaf as Chief Executive Officer and elevation of Dr.
George Milne to Chairman of the Board.
“On behalf of the entire organization, it is a pleasure to welcome
Daniel onto Aurinia’s Board of Directors. Throughout his career, Daniel
has led the international growth of novel biopharmaceutical treatments
for patients with debilitating kidney and inflammatory diseases, and we
look forward to his strategic insight and guidance with the ongoing
development of voclosporin,” commented Dr. George Milne, Chairman of the
Board of Directors.
Dr. Billen has more than four decades of experience leading the
commercialization of pharmaceutical and biotech products in North
America and Europe. Prior to his retirement, Dr. Billen served as Vice
President and General Manager, Inflammation and Nephrology at Amgen,
from 2011 until 2018. Prior to that, Dr. Billen was General Manager,
Amgen Canada, from 1991 until 2011. Dr. Billen previously served in
roles of escalating responsibility at Janssen from 1979 until 1991. Dr.
Billen received his Ph.D. in Chemistry from the University of Louvain,
Belgium.
“Voclosporin represents a potentially significant advancement for
patients with life-threatening kidney diseases, such as lupus
nephritis,” commented Dr. Billen. “After years of admiring Aurinia’s
development of voclosporin, it is an honour to now be joining the Board
of Directors and helping to guide this exciting program toward
commercialization.”
About Aurinia
Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical
company focused on developing and commercializing therapies to treat
targeted patient populations that are impacted by serious diseases with
a high unmet medical need. The Company is currently developing
voclosporin, an investigational drug, for the potential treatment of LN,
FSGS, and 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 calcineurin inhibitor (“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 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. Further, the new Notice of Allowance is
expected to result in the issuance of a U.S. patent with a term
extending to December 2037. If the FDA approves the use of voclosporin
for LN and the label for such use follows the dosing protocol under the
Notice of Allowance, the issuance of this patent will expand the scope
of intellectual property protection for voclosporin to December 2037.
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: voclosporin being a potentially
best-in-class CNI; patent protection for voclosporin being extended in
the United States and certain other major markets, including Europe and
Japan, until at least October 2027 and until April 2028 with an
anticipated pediatric extension; and intellectual property protection
for voclosporin being extended to December 2037 in respect of a patent
anticipated to be issued in connection with a new Notice of Allowance.
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: the costs and expenses associated
with Aurinia’s clinical trials; Aurinia receiving approval from
regulators to proceed with commercialization; Aurinia being able to
complete its clinical trials in a timely fashion; Aurinia being able to
extend its patents on terms acceptable to Aurinia; and the validity of
our patents. 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; difficulties we
may experience in completing the development and commercialization of
voclosporin; the market for the LN business may not be as estimated; and
regulatory authorities not granting approval for use of voclosporin in a
commercial manner, or not granting patents or extensions for patents at
all or as Aurinia currently anticipates. 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.
We seek Safe Harbor.
Contacts
Investors:
Glenn Schulman, PharmD, MPH
Corporate
Communications
gschulman@auriniapharma.com
Media:
Christopher Hippolyte, 212-364-0458
Christopher.Hippolyte@syneoshealth.com