Aurina Receives FDA Fast Track Designation for Voclosporin for the Treatment of Lupus Nephritis VICTORIA, British Columbia--(BUSINESS WIRE)

Receives FDA Fast Track Designation for Voclosporin

for the Treatment of Lupus Nephritis

VICTORIA, British Columbia--(BUSINESS WIRE)--March 2, 2016--Aurinia

Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the

"Company") announced today that the U.S. Food and Drug Administration

(FDA) has granted Fast Track designation for voclosporin, the

Company's next generation calcineurin inhibitor, for the treatment of

Lupus Nephritis (LN).

The Fast Track program was created by the FDA to facilitate the

development and expedite the review of new drugs that are intended to

treat serious or life-threatening conditions and that demonstrate the

potential to address significant unmet medical needs. Compounds that

receive this FDA designation benefit from more frequent meetings and

communications with the FDA to review the drug's development plan

including the design of clinical trials and the use of biomarkers to

support approval. Additionally, Fast Track designation allows the

Company to submit parts of the New Drug Application (NDA) on a rolling

basis for review as data becomes available.

The Company's 265 patient Phase 2b trial, called AURA (Aurinia

Urine protein Reduction in Active Lupus with

voclosporin) has recently completed enrollment and is currently underway

in over 20 countries worldwide. It is a randomized, controlled,

double-blind study comparing the efficacy of two doses of voclosporin

plus mycophenolate mofetil (MMF) vs. MMF alone in patients with active

LN. There will be a primary analysis to determine complete remission at

week 24 and various secondary analyses at week 48 which include

biomarkers and markers of non-renal SLE. The Company expects to analyse

and review the AURA data with the FDA later in 2016 in order to reach

agreement on further clinical development requirements.

"It is encouraging that Fast Track designation has been granted for voclosporin

and we look forward to working closely with FDA as we complete the AURA

trial. This designation demonstrates the substantial unmet medical need

for patients with LN and potentially helps move a promising therapy

through the FDA more rapidly." said Lawrence Mandt, Aurinia's Vice

President of Regulatory Affairs & Quality.

Aurinia is a clinical stage pharmaceutical company focused on the global

nephrology market. The fully-enrolled Phase 2b AURA-LV clinical trial is

evaluating the efficacy of its lead drug, voclosporin, as a treatment

for active LN. LN is an inflammation of the kidneys, that if

inadequately treated can lead to end-stage renal disease, making LN a

serious and potentially life-threatening condition.

Voclosporin is a novel and potentially best-in-class calcineurin

inhibitor ("CNI") with extensive clinical data in over 2,000 patients in

other indications. Voclosporin is made by a modification of a single

amino acid of the cyclosporine molecule (a CNI approved for use in

transplant patients since 1983). This modification results in a more

predictable pharmacokinetic and pharmacodynamic relationship, an

increase in potency vs. cyclosporine, an altered metabolic profile, and

potential for flat dosing.

The AURA study or "Aurinia Urine Protein Reduction in Active Lupus

Nephritis Study" is an adequate and well-controlled clinical trial that

enrolled 265 patients and is being conducted in over 20 countries

worldwide. This trial will compare the efficacy of voclosporin against

placebo in achieving remission in patients with active lupus nephritis.

The AURA study is designed to demonstrate that voclosporin can induce a

rapid and sustained reduction of proteinuria in the presence of

extremely low steroid exposure. It will compare two dosage groups of

voclosporin (23.7mg and 39.5mg) compared to placebo, with all patients

receiving mycophenolate mofetil (MMF) and oral corticosteroids as

background therapy. There will be a primary analysis to determine

complete remission at week 24 (confirmed at 26 weeks) and various

secondary analyses at week 48 which include biomarkers and markers of

We seek Safe Harbor.

Aurinia Pharmaceuticals Inc.

Chief Operating Officer

Financial Communications Inc.

Barry Mire, 416-644-2020