- Industry veteran, Max Colao, appointed Chief
Commercial Officer -
- Recruited four seasoned executives with
expertise across critical commercial functions -
- Rapidly preparing for the potential
commercialization of voclosporin during the first half of 2021
-
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia”
or the “Company”), a late-stage clinical biopharmaceutical company
focused on advancing voclosporin in multiple indications, today
announced the appointment of Max Colao to the newly created
position of Chief Commercial Officer. In addition, Aurinia has
recruited an experienced team of leaders across key commercial
functions including sales, marketing, market access, and commercial
operations.
“This is a very exciting time at Aurinia, and we are
laser-focused on executing on our strategy to prepare for a
commercial launch next year. Assembling a world-class commercial
leadership team in the months following the positive AURORA Phase 3
data is a testament to this commitment and voclosporin’s
potential,” said Peter Greenleaf, President and Chief Executive
Officer of Aurinia. “We believe the confirmatory AURORA data
represented a potential breakthrough for people affected by lupus
nephritis. The addition of Max’s invaluable experience, combined
with the collective capabilities and expertise of our growing
commercial organization, will be central to a successful market
entry.”
In preparing for potential commercialization in 2021, Aurinia is
building a distinguished team with proven experience in launching
therapies for nephrology and autoimmune indications. The Company
expects to file a new drug application (NDA) for voclosporin as a
potential treatment for lupus nephritis (“LN”) in the second
quarter of 2020. Joining the commercial organization along with Mr.
Colao are:
- Chris Hays, Vice President, Marketing;
- Fran Lynch, Vice President, Sales;
- Cara Felish, Vice President, Commercial Operations; and
- Tim Hermes, Vice President, Market Access.
These hires follow the recently reported positive efficacy and
safety results from the Company’s AURORA Phase 3 trial in the
treatment of LN. Voclosporin was granted Fast Track designation by
the FDA in 2016.
Max Colao brings nearly 30 years of world-class
commercial operations experience to his role at Aurinia. Prior to
leading U.S. commercial operations at Alexion and launching
multiple rare disease therapies, Mr. Colao spent nearly 20 years at
Amgen, holding roles of increasing responsibility on various
marketing and sales teams, most notably leading U.S. launches,
commercialization, and pricing strategy in the areas of
rheumatology, dermatology, and autoimmune disorders for Enbrel®,
Prolia®, and Nplate®. Most recently, he was Chief Commercial
Officer and Head of Business Development at Abeona, where he led
the company’s commercialization and business development efforts of
autologous cell therapy and AAV9-based gene therapy for rare
diseases. Mr. Colao received his B.S. in applied mathematics and
economics from the University of California, Los Angeles and his
MBA from the University of Southern California.
Chris Hays comes to Aurinia from AstraZeneca, where he
served as Senior Director and U.S. Head of the anemia business.
While at AstraZeneca, he built out the U.S. launch plan for new
products and therapy areas. Prior to AstraZeneca, Mr. Hays held
roles of increasing responsibility at Fresenius Medical Care North
America, where he developed programs and systems to enhance
effectiveness of the renal business. Before that, he spent nearly
10 years at Amgen, where he led marketing efforts across multiple
therapeutic units, including rheumatology and nephrology. Mr. Hays
received his B.S. from the University of Nevada, Las Vegas and his
MBA from Arizona State University.
Fran Lynch brings a wide range of sales experience across
multiple areas of business to his role at Aurinia. Most recently,
Mr. Lynch was responsible for expanding the sales force at UCB to
prepare for the launch of bimekizumab. Prior to UCB, he was
responsible for building out commercial teams at Sun
Pharmaceuticals, Takeda Pharmaceuticals, and Human Genome Sciences
(HGS). At HGS, he was responsible for the build out of sales and
leadership for the launch of BENLYSTA (belimumab), for systemic
lupus erythematosus (SLE). From 1998 to 2010, Mr. Lynch held roles
of increasing responsibility at Centocor Biotech (now Janssen
Biotech, a Johnson & Johnson company). While at Centocor, he
led teams in the rheumatology, gastroenterology, and dermatology
franchises. He has also led the commercial rollout of multiple
products, including ILUMYATM (tildrakizumab-asmn) and ENTYVIO
(vedolizumab). He received his B.S. in business administration from
the University of Delaware.
Cara Felish comes to Aurinia from Mallinckrodt
Pharmaceuticals, where she led the transition of all commercial
operations support (Analytics, Sales Operations, Training,
Marketing Operations) to a new NJ based headquarters. While at
Mallinckrodt, she also held a dual role as Chief of Staff
responsible for several strategic projects and facilitation of the
enterprise operating committee. Ms. Felish previously established a
global Sales Operations & Training function for Thermo Fisher
Scientific’s Clinical Diagnostics Division. She led Sales &
Marketing Operations at MedImmune (now AstraZeneca) and held
various Sales, Sales leadership and Project Management roles at
UnitedHealthcare Dental. She received her B.S. in communication
studies, with a minor in healthcare management, from Virginia
Tech.
Tim Hermes, a seasoned biotech executive, has held market
access leadership roles since 1998, where he has worked in a
variety of therapeutic areas including rare disease, CNS,
orthopedics, pain, and respiratory. Most recently, he served as
Vice President, Market Access at Ablynx (now Sanofi-Genzyme), where
he led the buildout from the North American subsidiary. Mr. Hermes
also developed Ablynx’s market access launch plan to introduce a
new innovative biologic for acquired thrombotic thrombocytopenic
purpura (aTTP) by conducting extensive payer and hospital research.
Before that, he served as Vice President, Government Affairs at
Depomed, Inc. (now Assertio Therapeutics, Inc.) and Collegium
Pharmaceutical, Inc., where he led market access launch plans. Mr.
Hermes also implemented marketing strategies at Auxilium
Pharmaceuticals, Inc. and Strategic Health Care. Mr. Hermes
received his B.S. in petroleum geology from Centenary College.
About Voclosporin Voclosporin, an investigational drug,
is a novel and potentially best-in-class calcineurin inhibitor
(“CNI”) with clinical data in over 2,600 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 (versus cyclosporine A),
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, a U.S. patent has also been issued covering the
voclosporin dosing protocol with a term extending to December 2037,
if the FDA incorporates the dosing protocol used in both the AURA
and AURORA trials into the product label.
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 an investigational drug,
for the treatment of lupus nephritis, focal segmental
glomerulosclerosis and dry eye syndrome. The Company’s head office
is in Victoria, British Columbia and focuses its development
efforts globally.
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: completing NDA priority review
submissions in a successful and timely manner including the
anticipated NDA filing during the second quarter of 2020; the
potential for commercial launch of voclosporin for use in LN in the
first half of 2021; voclosporin being potentially a best-in-class
CNI with robust intellectual property exclusivity; Aurinia’s
anticipation that upon regulatory approval, patent protection for
voclosporin 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; a US patent has also been issued
covering the voclosporin dosing protocol with a term extending to
December 2037, if the FDA incorporates the dosing protocol used in
both the AURA and the AURORA studies into the product label; that
Aurinia has hired seasoned, distinguished world-class commercial
leadership; ; that voclosporin may be positioned to become the
standard of care for people living with LN; that Aurinia will
present AURORA study results at a future scientific conference
during 2020. 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 market value for the LN, DES and FSGS
programs; that another company will not create a substantial
competitive product for Aurinia’s LN, DES and FSGS business without
violating Aurinia’s intellectual property rights; the burn rate of
Aurinia’s cash for operations; the costs and expenses associated
with Aurinia’s clinical trials; the planned studies achieving
positive results; Aurinia being able to extend and protect its
patents on terms acceptable to Aurinia; and the size of the LN, DES
or FSGS markets; Aurinia will be able to obtain all necessary
regulatory approvals for commercialization of voclosporin for use
in LN on terms that are acceptable to it and that are commercially
viable; and that Aurinia’s intellectual property rights are valid
and do not infringe the intellectual property rights of other
parties. 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 clinical trial; difficulties we may experience
in completing the development and commercialization of voclosporin;
the market for the LN, DES and FSGS business may not be as
estimated; Aurinia may have to pay unanticipated expenses;
estimated costs for clinical trials may be underestimated,
resulting in Aurinia having to make additional expenditures to
achieve its current goals; Aurinia not being able to extend or
fully protect its patent portfolio for voclosporin; competitors may
arise with similar products; Aurinia may not be able to obtain
necessary regulatory approvals for commercialization of voclosporin
in a timely fashion, or at all; and Aurinia may not be able to
obtain sufficient supply to meet commercial demand for voclosporin
in a timely fashion. 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 harbour.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200225005357/en/
For more information: Investor
& Corporate Contact: Glenn Schulman, PharmD, MPH Corporate
Communications, Aurinia gschulman@auriniapharma.com
Media Contact Krystle Gibbs Ten Bridge Communications
krystle@tenbridgecommunications.com
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