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
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