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Aurinia Pharmaceuticals Inc
Symbol AUP
Shares Issued 78,544,535
Close 2017-04-06 C$ 8.84
Market Cap C$ 694,333,689
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Aurinia upbeat about international talks on voclosporin

2017-04-06 17:25 ET - News Release

Mr. Richard Glickman reports

AURINIA ANNOUNCES DEVELOPMENT PLANS FOR VOCLOSPORIN IN EUROPE AND JAPAN

Aurinia Pharmaceuticals Inc. is providing the outcome of discussions with both the European Medicines Agency (EMA) and the Pharmaceutical and Medical Devices Agency (PMDA) in Japan regarding the development of voclosporin for the treatment of active lupus nephritis (LN). Pursuant to these discussions, the company believes that the confirmatory data that can be generated from the single phase III clinical trial (Aurora) and the recently completed Aura-LV (Aura) phase IIb study should support regulatory submissions in the United States, Europe and Japan.

"Our interactions with regulators in all three jurisdictions have given us a clear pathway for phase III, and we are confident in our ability to execute Aurora successfully based on their feedback and the information gleaned from the Aura study," said Lawrence D. Mandt, vice-president of quality and regulatory affairs at Aurinia. "The productive conclusion of these regulatory interactions marks a milestone in our development program and brings this exciting new therapeutic option one step closer to those patients suffering from LN."

The phase III Aurora trial will be a global 52-week double-blind, placebo-controlled study of approximately 320 patients. Patients will be randomized 1:1: to either of 23.7 milligram voclosporin BID and mycophenolate mofetil (MMF) or MMF and placebo, with both arms receiving a stringent oral corticosteroid taper. As in Aura, the study population will be composed of patients with biopsy-proven active LN who will be evaluated on the primary efficacy end point of complete remission, or renal response, at 52 weeks, a composite which includes:

  • Urinary/protein creatinine ratio (UPCR) of (equals) 0.5 mg/mg;

  • Normal, stable renal function ((equals) 60 millilitre/min/1.73 square metre or no confirmed decrease from baseline in eGFR of greater than 20 per cent);

  • Presence of sustained, low-dose steroids ((equals) 10 mg prednisone from week 16 through 24);

  • No administration of rescue medications.

"Based on the recent learnings from the positive AURA study at 48 weeks, we intend to use a UPCR of (equals) 0.5 mg/mg and evaluate the primary endpoint at 52 weeks in Aurora," added Richard M. Glickman, Aurinia's chief executive officer. "We are on track to initiating the global Aurora study this quarter and fulfilling our goal of improving the long-term outcomes for patients with this disease."

About Aurinia Pharmaceuticals Inc.

Aurinia is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of LN.

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