Biotech

- Integrated analysis confirms addition of voclosporin to standard-of-care resulted in faster Renal Response compared to standard-of-care alone in lupus nephritis -

- DDI study demonstrates no clinically meaningful interaction between voclosporin and MMF, supporting differentiation as a potential best-in-class CNI -

Aurinia Pharmaceuticals Inc. (Nasdaq: AUPH / TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company, today announced data from an integrated analysis of the AURA-LV and AURORA pivotal trials that further supports voclosporin as a potential treatment for lupus nephritis (LN) in a presentation at the American College of Rheumatology (ACR) Convergence 2020. The Company also shared data from a clinical drug-drug interaction (DDI) study in patients with systemic lupus erythematosus (SLE), showing that voclosporin does not have a meaningful drug-drug interaction when administered with mycophenolate mofetil (MMF). The topline results from this DDI study were previously announced in late 2019.

The data at ACR were presented by Ellen Ginzler, M.D., MPH, Distinguished Teaching Professor of Medicine and Chief of Rheumatology at the SUNY Downstate Health Sciences University and Teun van Gelder, M.D., Ph.D., Professor in Clinical Pharmacology for the Department of Clinical Pharmacy and Toxicology at the Leiden University Medical Center.

"We are delighted to share more encouraging data on the use of voclosporin for lupus nephritis to this influential group of rheumatology experts at ACR," said Neil Solomons, M.D., Chief Medical Officer of Aurinia. "With few effective options, rheumatologists have struggled to find effective therapies for patients with lupus nephritis. These two studies, along with the growing body of data supporting the use of voclosporin, clearly demonstrate the benefits of this therapy to provide effective and safe treatment."

The integrated data presented by Dr. Ginzler demonstrated that patients with LN treated with voclosporin in combination with MMF and low-dose steroids achieved statistically superior and faster Renal Response (RR) rates compared to patients treated with MMF and steroids alone. Treatment with voclosporin (VCS) resulted in clinically meaningful and a statistically significant higher RR rate of 43.7% compared to 23.3% in the control arm at one year (OR 2.76, 95% CI: 1.88, 4.05; p

The AURA-LV and AURORA studies were of similar design and conducted in comparable patient populations. The data from both studies for patients treated with the recommended voclosporin dose of 23.7 mg BID (AURORA; n=179, AURA; n=89) or with matching placebo (AURORA; n= 179, AURA-LV; n=89) were therefore pooled for an integrated analysis of efficacy.

Dr. Van Gelder presented data from a clinical DDI study in patients with SLE that investigated the potential effect of voclosporin on blood levels of mycophenolate acid (MPA), the active moiety MMF. MMF, also known as CellCept®, is considered by treating physicians to be part of the current standard of care for LN in the United States. The study demonstrated for the first time that voclosporin does not have a meaningful drug-drug interaction when administered with MMF. In contrast to cyclosporine A, voclosporin does not have clinically significant impacts on MPA blood concentrations, which indicates that voclosporin and MMF can be administered concomitantly without the need to adjust the dose of MMF.

These data presented at ACR Convergence 2020 were submitted as part of voclosporin's new drug application (NDA) to the United States Food and Drug Administration (FDA). The FDA accepted the NDA and has assigned a Prescription Drug User Fee Act (PDUFA) target action data of January 22, 2021.

About Aurinia

Aurinia Pharmaceuticals is a late-stage clinical 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 seeking FDA approval of voclosporin for the potential treatment of LN. The Company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

Investors & Corporate:
Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia
gschulman@auriniapharma.com

Media
Stefan Riley
Ten Bridge Communications
stefan@tenbridgecommunications.com

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AMGEN REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS

Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2022. Key results include:

  • Total revenues increased 1% to $6.6 billion in comparison to the second quarter of 2021, resulting from 3% growth in global product sales partially offset by lower Other Revenue from our COVID-19 manufacturing collaboration.
    • Volumes grew double-digits for a number of products including Repatha ® (evolocumab), Prolia ® (denosumab), LUMAKRAS ® /LUMYKRAS™ (sotorasib) and EVENITY ® (romosozumab-aqqg).
  • GAAP earnings per share (EPS) increased from $0.81 to $2.45 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired In-Process Research & Development (Acquired IPR&D) associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022, partially offset by an impairment charge related to the divestiture of GENSENTA, a generics subsidiary in Turkey .
    • GAAP operating income increased from $0.8 billion to $2.2 billion , and GAAP operating margin increased 21.1 percentage points to 34.6%.
  • Non-GAAP EPS increased from $1.77 to $4.65 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired IPR&D associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022.
    • Non-GAAP operating income increased from $1.6 billion to $3.3 billion , and non-GAAP operating margin increased 26.8 percentage points to 53.1%.
  • The Company generated $1.7 billion of free cash flow for the second quarter versus $1.7 billion in the second quarter of 2021.
  • 2022 total revenues guidance revised to $25.5 - $26.4 billion ; EPS guidance revised to $11.01 - $12.15 on a GAAP basis, and reaffirmed at $17.00 - $18.00 on a non-GAAP basis.

"We are focused on delivering our long-term objectives by serving an ever-increasing number of patients around the world with our medicines," said Robert A. Bradway , chairman and chief executive officer. "We are advancing our pipeline and look forward to important readouts over the next few months."

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The Gummy Project Secures Additional Repeat Order from Existing Customer Flair Airlines

The Gummy Project Secures Additional Repeat Order from Existing Customer Flair Airlines

  • The Company had previously announced its first repeat order with existing customer Bard on the Beach.
  • Partnership with Flair rapidly accelerates The Gummy Project's growth across Canada with GUMY products being featured for sale on all Flair flights.
  • As the "Better for You" gummy company, The Gummy Project, through its Flair Airlines partnership, will extend the reach and effectiveness of its purpose driven mission to support endangered keystone species.

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is excited to announce that the Company has received a repeat order from its existing customer Flair Airlines ("Flair").

"We are very pleased to receive our second repeat order from an existing customer. We view this as another vote of confidence that our customers are very much enjoying our gummies and strongly embracing our mandate to support endangered keystone species," said Charlie Lamb, President & CEO of The Company. "We look forward to building upon the momentum that the Company has created as we continue to accelerate revenue generation and brand awareness."

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Gilead Sciences to Acquire MiroBio

Acquisition Provides Gilead with MiroBio's Pipeline of Immune Checkpoint Agonists and Proprietary Discovery Platform –

– MiroBio's Scientific Approach to Restoring Immune Balance for the Treatment of Autoimmune Diseases Complements Gilead's Inflammation Research and Development Strategy –

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AMGEN TO ACQUIRE CHEMOCENTRYX FOR $4 BILLION IN CASH

Acquisition Includes TAVNEOS ® (avacopan), a First-in-Class Medicine for Patients With Serious Autoimmune Disease

Tavneos Adds to Amgen's Decades-Long Leadership in Inflammation and Nephrology

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Aurinia Reports Second Quarter and Six Months 2022 Financial and Operational Results

Net revenue increased to $28.2 million for Q2 2022; Maintains net revenue guidance range of $115-$135 million from sales of LUPKYNIS ® (voclosporin) for 2022

Continued increases in LUPKYNIS Patients on Treatment; Steady Conversion Rates and Payor Coverage

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Boosh Plant-Based Brands Announces Delay of Filings

Boosh Plant-Based Brands Announces Delay of Filings

Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77i) ("Boosh" or the "Company") a premier plant-based brand in the in-health food sector, announces today that a management cease trade order was granted on August 2, 2022 (the "MCTO") by the British Columbia Securities Commission under National Policy 12-203 - Management Cease Trade Orders ("NP 12-203"), as the Company anticipates delays in filing its financial statements for the year ended March 31, 2022, and the related management's discussion and analysis ("MD&A") and certifications (the "Annual Filings"). The MCTO does not affect the ability of investors who are not insiders to trade in the securities of the Company.

The Company will work with its auditors to complete the audit of the Company's consolidated financial statements and expects to file the Annual Filings by August 31, 2022. The delays are primarily the result of the close proximity of the Company's acquisition of substantially all of the assets of Beanfields, Inc. on February 16, 2022, and the Company's financial year end of March 31, and the work required to consolidate those operations.

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