Aurinia Announces the Addition of Three Seasoned Executive Leaders to Advance Company Strategy and Performance

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

Media:  
Dana Lynch
Corporate Communications, Aurinia
dlynch@auriniapharma.com

Investors:  
aurinia@westwicke.com

News Provided by Business Wire via QuoteMedia

AUP:CA,AUPH
Syntheia

Syntheia Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

The Conversation (0)
Syntheia (CSE:SYAI)

Syntheia


Keep reading...Show less

AMGEN PRESENTS NEW DATA ACROSS RARE INFLAMMATORY DISEASES AT ACR 2024

MITIGATE Phase 3 Study Results Reinforce Promise of UPLIZNA ®   as the First Potential Treatment tor IgG4-RD

Phase 4 AGILE Data Support Shortening KRYSTEXXA ® Infusion Time

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Collage with hands holding shiny DNA molecule on blue background.

5 Biggest Biotechnology ETFs in 2024

Investing in the biotech industry can be a long road to gains given the sector’s volatility.

Even with a good understanding of the system, no one can predict which treatment, device or therapy will give the biggest return, making biotech exchange-traded funds (ETFs) a more secure option than individual biotech stocks.

An ETF is a relatively safe investment route that can minimize losses while offering exposure to multiple companies instead of focusing on the gains and losses of a single biotech stock. With that in mind, here’s a brief look at the five top biotechnology ETFs by total assets under management (AUM). Data was sourced from ETFdb.com on November 13, 2024, and all data was current as of that time.

Keep reading...Show less
Cardiol Therapeutics Inc. Added to PRISM Emerging Biotech Index

Cardiol Therapeutics Inc. Added to PRISM Emerging Biotech Index

PRISM MarketView a leading provider of market insights and company news, proudly announces that Cardiol Therapeutics Inc. ( NASDAQ: CRDL, TSX: CRDL ) has been added to the PRISM Emerging Biotech Index, which spotlights companies leading innovation and creating market impact within the biotech sector. Cardiol's focus on anti-inflammatory and anti-fibrotic therapies for heart disease, including its lead candidate CardiolRx™, positions it as a pioneer in addressing major unmet needs in cardiac care.

The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis. Cardiol's MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The MAVERIC-2 trial will evaluate the impact of CardiolRx™ in recurrent pericarditis patients following the cessation of interleukin-1 blocker therapy. MAVERIC-2 is expected to initiate in Q4 2024 at major pericardial disease centers across the United States and Europe, with results anticipated ahead of the company's planned pivotal Phase III MAVERIC-3 trial.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

AMGEN PROVIDES STATEMENT ON MARITIDE PHASE 1 DATA

Amgen (NASDAQ:AMGN) today issued the following statement on the MariTide (maridebart cafraglutide, formerly AMG 133) Phase 1 data.

"As previously stated, Amgen does not see an association between the administration of MariTide and bone mineral density changes. The Phase 1 study results do not suggest any bone safety concern or change our conviction in the promise of MariTide. We look forward to sharing the Phase 2 topline data later this year."

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

AMGEN TO PRESENT AT THE 2024 UBS GLOBAL HEALTHCARE CONFERENCE

Amgen (NASDAQ:AMGN) will present at the 2024 UBS Global Healthcare Conference at 10:15 a.m. PT on Wednesday Nov. 13, 2024. Peter Griffith executive vice president and chief financial officer at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

TEZSPIRE MET BOTH CO-PRIMARY ENDPOINTS IN PHASE 3 TRIAL FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS

Statistically Significant Reduction in Nasal Polyp Size, Nasal Congestion Compared to Placebo

Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]). The trial demonstrated patients treated with TEZSPIRE ® (tezepelumab-ekko) had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo. The safety profile and tolerability of TEZSPIRE in the trial were consistent with the known profile of the medicine.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Syntheia

Syntheia Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

Latest Press Releases

Related News

×