Volker Knappertz, MD, as Executive Vice
President, Research and Development, to lead the consolidated
R&D function and to further enhance and advance the Aurinia
pipeline
Scott Habig, as Chief Commercial Officer, to
lead and enhance Aurinia’s commercial capabilities, replacing Max
Colao, who led the formation of the commercial organization and the
launch of Aurinia’s first FDA-approved product LUPKYNIS®
DeDe Sheel, as Vice President of Investor
Relations (IR), to manage all aspects of investor relations
programs to support company growth
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the
Company), a biopharmaceutical company committed to delivering
therapeutics that change the course of autoimmune disease, today
announced the appointment of three seasoned leaders to the Aurinia
executive team. Volker Knappertz, MD, will join Aurinia as
Executive Vice President (EVP), Research and Development to lead
the consolidated Research and Development function. Additionally,
Scott Habig has been named Aurinia’s new Chief Commercial Officer
and will lead efforts to ensure further commercial success for
LUPKYINIS®, Aurinia’s first FDA approved product, as well as future
products. DeDe Sheel has been hired as Vice President (VP),
Investor Relations, where she will manage the Company’s
relationships with investors and analysts, and assist them in
understanding the Company’s business model, long-term strategy,
governance, and financial performance.
Max Colao, who led the formation of Aurinia’s commercial
organization and the launch of LUPKYNIS in 2021, is leaving the
company to tend to personal matters. Neil Solomons, MD, Chief
Medical Officer and Robert B. Huizinga, PhD, RN, CNeph(C), EVP,
Research will remain in their current roles and continue as members
of the executive committee.
“These new hires bring a wealth of critical experience to
Aurinia, and I am thrilled to add them to our team as we continue
to execute on our strategy of building a fully integrated
biopharmaceutical company,” said Peter Greenleaf, President, and
Chief Executive Officer of Aurinia. “Volker has a strong track
record of advancing biotechnology and medical innovation and is
recognized for his leadership in creating diverse, high performing
teams, and fostering creativity in R&D. Scott joins us at a
pivotal time as we work to expand upon our LUPKYNIS launch momentum
and advance our early-stage pipeline. I look forward to leveraging
his unique lupus and rheumatology sales and marketing expertise to
drive further adoption of our first commercial product and ensure
success for future pipeline assets. Finally, with the addition of
DeDe, we reinforce our commitment to key investor audiences and
shareholders. DeDe has a proven history of building best-in-class
investor relations functions, and she will leverage this expertise
to drive awareness and understanding of Aurinia’s commercial
operations, pipeline and vision for the future. We are thrilled to
have her as part of the team.”
Volker Knappertz, MD most recently served as the Chief Medical
Officer and Executive VP of Research and Development at GW
Pharmaceuticals, developing medicines for rare and orphan diseases
as well as epilepsy, multiple sclerosis, schizophrenia, autism
spectrum disorders and neurodegenerative diseases. At GW, he was
instrumental in driving the transformation of GW from a botanical
pharmaceutical company to a fully integrated biopharmaceutical
R&D and innovation focused organization, the development of a
deep pipeline of both plant-derived and synthetic drug candidates
and growing the R&D organization to over 350 internal
employees. Previously, Volker was the VP of Global Clinical
Development at Teva Pharmaceuticals, for multiple sclerosis,
oncology and biosimilar products achieving several drug approvals.
Dr. Knappertz received his magna cum laude doctorate and Medical
Degree from Cologne University. He was trained in Neurology at Yale
University and is a US board certified neurologist and has served
as adjunct faculty in Neurology at the University of Pennsylvania
and Heinrich-Heine University in Düsseldorf.
Scott Habig joins Aurinia after serving for the past 10 years in
numerous leadership roles at UCB, Inc. Most recently, he was Head
of Global SLE, maintaining full responsibility for pre-launch and
commercial launch activities of a novel CD40 ligand currently in
Phase III of clinical development for Systemic Lupus Erythematosus
(SLE). Scott brings more than 20 years of global and U.S. sales and
marketing experience to Aurinia, with strong relevant knowledge of
the Rheumatology and Lupus markets. His previous roles include VP,
Sales at Human Genome Sciences, where he led the development and
execution of organizational capabilities and infrastructure to
support the company’s first sales team and led organizational and
operational initiatives to guide the first major Lupus drug launch
in more than 50 years. Prior to this role, Scott spent nine years
at Centocor, Inc. where he led development and execution of sales
and marketing strategies for one of the first biologic therapies
approved for multiple autoimmune disorders. Under Scott’s sales and
marketing leadership at Centocor, the company transformed a
multimillion-dollar pipeline into a multibillion-dollar product.
Scott replaces Max Colao who is departing Aurinia to tend to
personal matters.
“On behalf of the entire organization, I’d like to thank Max
Colao for his tireless contributions and tremendous impact at
Aurinia these past two years. Under his leadership, we now have a
strong commercial organization, and our first product is in market
helping patients in need,” said Peter Greenleaf, President, and
Chief Executive Officer of Aurinia. “With this strong foundation
built, we are in a great position for growth, and I look forward to
working with Scott to continue to advance our corporate goals and
ultimately help patients to live fuller lives.”
DeDe Sheel comes to Aurinia with over 15 years of experience in
IR, most recently as Vice President, Investor Relations at Sierra
Oncology (acquired by GSK) and Vice President, Investor relations
at Aimmune Therapeutics (acquired by Nestlé Health Science). She
also led investor relations at Myovant Sciences, Anacor
Pharmaceuticals (acquired by Pfizer) and Exelixis. As the head of
the IR, she successfully diversified and expanded the shareholder
bases as the companies transitioned from development stage to
commercial stage, and she was instrumental in securing
approximately $1B of equity and debt financings. Prior to working
in investor relations, DeDe was in healthcare investment banking,
first with Banc of America Securities and then Deutsche Bank. She
holds an MBA from NYU Stern School of Business and a B.S. in
Business Administration from UC Berkeley.
About LUPKYNIS LUPKYNIS® is the first FDA-approved oral
medicine for the treatment of adult patients with active lupus
nephritis (LN). LUPKYNIS is a novel, structurally modified
calcineurin inhibitor (CNI) with a dual mechanism of action, acting
as an immunosuppressant through inhibition of T-cell activation and
cytokine production and promoting podocyte stability in the kidney.
The recommended starting dose of LUPKYNIS is three capsules twice
daily with no requirement for serum drug monitoring. Dose
modifications can be made based on Aurinia’s proprietary
personalized eGFR-based dosing protocol. Boxed Warning, warnings,
and precautions for LUPKYNIS are consistent with those of other
CNI-immunosuppressive treatments.
About Aurinia Aurinia Pharmaceuticals is a fully
integrated biopharmaceutical company focused on delivering
therapies to treat targeted patient populations that are impacted
by serious diseases with a high unmet medical need. In January
2021, the Company introduced LUPKYNIS® (voclosporin), the first
FDA-approved oral therapy for the treatment of adult patients with
active lupus nephritis (LN). The Company’s head office is in
Victoria, British Columbia, its U.S. commercial hub is in
Rockville, Maryland. The Company focuses its development efforts
globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS LUPKYNIS is indicated in combination with a
background immunosuppressive therapy regimen for the treatment of
adult patients with active LN. Limitations of Use: Safety and
efficacy of LUPKYNIS have not been established in combination with
cyclophosphamide. Use of LUPKYNIS is not recommended in this
situation.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious infections
with LUPKYNIS or other immunosuppressants that may lead to
hospitalization or death.
CONTRAINDICATIONS LUPKYNIS is contraindicated in patients
taking strong CYP3A4 inhibitors because of the increased risk of
acute and/or chronic nephrotoxicity, and in patients who have had a
serious/severe hypersensitivity reaction to LUPKYNIS or its
excipients.
WARNINGS AND PRECAUTIONS Lymphoma and Other Malignancies:
Immunosuppressants, including LUPKYNIS, increase the risk of
developing lymphomas and other malignancies, particularly of the
skin. The risk appears to be related to increasing doses and
duration of immunosuppression rather than to the use of any
specific agent.
Serious Infections: Immunosuppressants, including LUPKYNIS,
increase the risk of developing bacterial, viral, fungal, and
protozoal infections (including opportunistic infections), which
may lead to serious, including fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute
and/or chronic nephrotoxicity. The risk is increased when CNIs are
concomitantly administered with drugs associated with
nephrotoxicity.
Hypertension: Hypertension is a common adverse reaction of
LUPKYNIS therapy and may require antihypertensive therapy.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum
of neurotoxicities: severe include posterior reversible
encephalopathy syndrome (PRES), delirium, seizure, and coma; others
include tremor, paresthesia, headache, and changes in mental status
and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and require
treatment, has been reported with CNIs, including LUPKYNIS.
Concomitant use of agents associated with hyperkalemia may increase
the risk for hyperkalemia.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a
dose-dependent manner when dosed higher than the recommended lupus
nephritis therapeutic dose. The use of LUPKYNIS in combination with
other drugs that are known to prolong QTc may result in clinically
significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines during
treatment with LUPKYNIS. Inactivated vaccines noted to be safe for
administration may not be sufficiently immunogenic during treatment
with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA)
have been reported in patients treated with another CNI
immunosuppressant. If PRCA is diagnosed, consider discontinuation
of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and
strong CYP3A4 inhibitors or with strong or moderate CYP3A4
inducers. Reduce LUPKYNIS dosage when co-administered with moderate
CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with
narrow therapeutic windows when co-administered.
ADVERSE REACTIONS The most common adverse reactions
(>3%) were glomerular filtration rate decreased, hypertension,
diarrhea, headache, anemia, cough, urinary tract infection,
abdominal pain upper, dyspepsia, alopecia, renal impairment,
abdominal pain, mouth ulceration, fatigue, tremor, acute kidney
injury, and decreased appetite.
SPECIFIC POPULATIONS Pregnancy/Lactation: May cause fetal
harm. Advise not to breastfeed.
Renal Impairment: Not recommended in patients with baseline eGFR
≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal
impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose.
Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information, including Boxed Warning, and
Medication Guide for LUPKYNIS
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220714005778/en/
Media: Dana Lynch Corporate Communications, Aurinia
dlynch@auriniapharma.com Investors:
aurinia@westwicke.com
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