- Appointments effective as of April 29, 2019
-
Dr. Richard M. Glickman to retire from executive and board roles
and remain an advisor to the Company for one year
VICTORIA, British Columbia–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the
“Company”), a late clinical-stage biopharmaceutical company focused on
the global immunology market, today announced the appointment of Mr.
Peter Greenleaf as Chief Executive Officer and as a Director on the
Aurinia Board. The Company also announced the elevation of George M.
Milne, Jr., Ph.D. to Chairman of the Board of Directors. Dr. Richard M.
Glickman, who previously announced his plans to retire on November 6,
2018, will step down from his role as Chairman and CEO concurrent with
Mr. Greenleaf’s appointment on April 29, 2019, and will remain an
advisor to the Company for a period of 12 months.
With more than twenty years of experience leading pharmaceutical and
biotech firms, Mr. Greenleaf most recently served as the CEO of Cerecor,
a leading U.S. pediatric orphan and rare disease pharmaceutical company.
Prior to that, Mr. Greenleaf was the Chairman and CEO of Sucampo
Pharmaceuticals which he led through the successful sale to Mallinckrodt
Pharmaceuticals, PLC for $1.2B. Previously, Mr. Greenleaf served as the
CEO and Board member of Histogenics, a regenerative medicine company.
Prior to that he was the President of MedImmune, Inc, the global
biologics arm of AstraZeneca, and President of MedImmune Ventures, a
wholly owned venture capital fund within the AstraZeneca Group, where he
led investment in emerging biopharmaceutical, medical device, and
diagnostic companies.
“It is a pleasure to welcome Peter as the next Chief Executive Officer
of Aurinia. As a seasoned leader in the pharmaceutical industry, Peter’s
extensive knowledge of clinical and overall operations, along with
business development and commercialization expertise, are ideally
aligned with the next stages of growth for voclosporin and Aurinia,”
stated Dr. George Milne, incoming Chairman of the Board of Aurinia
Pharmaceuticals.
“The Aurinia team has made extraordinary progress with
voclosporin, which I believe to be a truly transformative drug for the
potential treatment of proteinuric kidney diseases, such as lupus
nephritis (“LN”), as well as a unique opportunity for the treatment of
dry eye syndrome (“DES”),” commented Mr. Greenleaf. “To that end, I am
very excited to lead the Company at this pivotal time and through
several critical datapoints over the next year including Phase 3 trial
results by the end of 2019, followed by the planned regulatory
submission and preparations for the potential commercialization of
voclosporin during 2020.”
Dr. Milne further commented, “I am also humbled to be assuming the
Chairman role from Dr. Glickman. On behalf of the entire board and
organization, I would like to thank Dr. Glickman for all of his efforts
and contributions that have brought Aurinia to where it is today. As we
wish him all the best on his retirement, we are also gratified to have
his insight as an advisor for the next year.”
Dr. Glickman stated, “Consistent with the succession planning set into
motion last November, I am confident that Peter is the correct
individual to lead Aurinia through the next set of value inflection
points including the upcoming AURORA Phase 3 results, preparing for the
potential launch of voclosporin, and expansion of the VOS dry eye
syndrome program.”
About Mr. Peter Greenleaf
Peter Greenleaf previously served as CEO of Cerecor, Inc., since March
2018. Prior to that he served as Chairman and CEO of Sucampo
Pharmaceuticals, Inc. from March 2014 to February 2018, when Sucampo was
sold to Mallinckrodt PLC. Previously, Mr. Greenleaf served as CEO of
Histogenics Corporation from June 2013 to March 2014, as President of
MedImmune, Inc., and MedImmune Ventures from 2010 to June 2013, and
Senior Vice President, Commercial Operations of MedImmune from 2006 to
2010. Mr. Greenleaf also held senior commercial roles at Centocor
Biotech, Inc. (now Janssen Biotechnology, Johnson & Johnson), from 1998
to 2006, and at Boehringer Mannheim G.m.b.H. (now Roche Holdings) from
1996 to 1998. Mr. Greenleaf is a member of the Board of Directors of
Cerecor since May 2017, is the Chairman of the Board of Bio-delivery
Sciences since May 2018, EyeGate Pharmaceuticals since August 2018, and
Antares Pharma since December 2018. Mr. Greenleaf chairs the Maryland
Venture Fund Authority, and previously served on the boards of BIO,
PhARMA, the Tech Council of Maryland and the University of Maryland
Baltimore Foundation, Inc. Mr. Greenleaf earned an MBA degree from St.
Joseph’s University and a BS degree from Western Connecticut State
University.
About George M. Milne, Jr., Ph.D.
Dr. Milne was appointed to the Aurinia Board of Directors in May 2017
and serves as Chair of the Company’s Governance & Nomination Committee.
Dr. Milne has over 30 years of experience in pharmaceutical research and
product development. He joined Pfizer in 1970 and held a variety of
positions conducting both chemistry and pharmacology research. Dr. Milne
became director of the department of immunology and infectious diseases
at Pfizer in 1981, was its executive director from 1984 to 1985, and was
vice president of research and development from 1985 to 1988. He was
appointed senior vice president in 1988. In 1993 he was appointed
President of Pfizer Central Research and a senior vice president of
Pfizer with global responsibility for human and veterinary medicine
research and development. Dr. Milne has served on multiple corporate
boards including Mettler-Toledo, Inc., MedImmune, Athersys, Biostorage
Technologies, Aspreva, and Conor Medsystems. Dr. Milne received his
B.Sc. in Chemistry from Yale University and his Ph.D. in Organic
Chemistry from MIT.
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, Focal Segmental Glomerulosclerosis (“FSGS”),
and DES. The Company is headquartered in Victoria, British Columbia and
focuses its development efforts globally. For further information, see
our website at http://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 transformative drug for the potential treatment of proteinuric kidney
diseases, such as lupus nephritis, as well as a unique opportunity for
the treatment of dry eye syndrome; results from the Company’s Phase 3
trial in lupus nephritis by the end of 2019; timing for regulatory
approval and commercialization of voclosporin for use in lupus
nephritis; 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
Investor Contact:
Glenn Schulman, PharmD, MPH
Corporate Communications
gschulman@auriniapharma.com
Media Contact:
Christopher Hippolyte, 212-364-0458
Christopher.Hippolyte@syneoshealth.com