Aurinia Releases Open-Label AURION Data Demonstrating Increased Remission Rates over Time for Voclosporin in the Treatment of Lupus Nephritis - Complete remission rates increase to 70% in the open-label study at 24 weeks

Releases Open-Label AURION Data Demonstrating Increased Remission Rates

over Time for Voclosporin in the Treatment of Lupus Nephritis

Complete remission rates increase to 70% in the open-label study at 24

in remission at eight weeks remained in remission at 24 weeks

presented at the 10th

Annual European Lupus Meeting

VICTORIA, British Columbia--(BUSINESS WIRE)--October 6, 2016--Aurinia

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

"Company") a clinical stage biopharmaceutical company focused on the

global immunology market, today announced 24-week data in all 10

patients from the AURION study, an open-label exploratory study to

assess the short-term predictors of response using voclosporin (23.7mg

BID) in combination with mycophenolate mofetil (MMF) and oral

corticosteroids in patients with active lupus nephritis (LN). The data

are being presented by Robert Huizinga, Vice President of Clinical

Affairs at Aurinia at the 10th Annual European Lupus Meeting

The primary objective of the study is to examine biomarkers of disease

activity at eight weeks and their ability to predict response at 24 and

In this study, 70% (7/10) patients achieved complete remission (CR) at

24 weeks as measured by a urinary protein creatinine ratio (UPCR) of

0.5mg/mg, eGFR within 20% of baseline and concomitant steroid dose of

<5mg/day. Of the 10 patients that achieved a reduction of UPCR of 25%

at 8 weeks, 80% were responders ( 50% reduction in UPCR over baseline)

at 24 weeks and 70% were in CR at 24 weeks. In addition, inflammatory

markers such as C3, C4 and anti-dsDNA all continued to normalize to 24

weeks. Voclosporin was well-tolerated with no unexpected safety signals

"The results of AURION provide further proof of concept data to support

voclosporin's use in the treatment of active LN and continue to indicate

that 23.7mg BID is the optimal dose to advance into our phase III

program," said Neil Solomons, MD, Chief Medical Officer of Aurinia. "We

are encouraged by our ability to quickly predict responses and remission

rates in these patients, which can help clinicians optimize patient care

and long-term outcomes."

Details of the results are below:

*Retrospectively defined by 50% reduction in UPCR

The AURION study or "Aurinia Early Urinary

Protein Reduction Predicts Response Study" is an open-label, exploratory

study being conducted in multiple sites in Malaysia to assess the short

term predictors of response using voclosporin (23.7mg) in combination

with mycophenolate mofetil and oral corticosteroids in patients with

active lupus nephritis. This study will examine biomarkers of disease

activity at 8 weeks and their ability to predict response at 24 and 48

Voclosporin, an investigational drug,

is a novel and potentially best-in-class calcineurin inhibitor ("CNI")

with clinical data in over 2,000 patients in other indications.

Voclosporin is an immunosuppressant, with a synergistic and dual

mechanism of action that has the potential to improve near- and

long-term outcomes in LN when added to standard of care (MMF). By

inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell

mediated immune responses. It is made by a modification of a single

amino acid of the cyclosporine molecule which has shown a more

predictable pharmacokinetic and pharmacodynamic relationship, an

increase in potency, an altered metabolic profile, and potential for

flat dosing. The Company anticipates that upon regulatory approval,

patent protection for voclosporin will be extended in the United States

and certain other major markets, including Europe and Japan, until at

least October 2027 under the Hatch-Waxman Act and comparable laws in

About Lupus Nephritis (LN)

Lupus Nephritis (LN) in an

inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE)

and represents a serious progression of SLE. SLE is a chronic, complex

and often disabling disorder and affects more than 500,000 people in the

United States (mostly women). The disease is highly heterogeneous,

affecting a wide range of organs & tissue systems. It is estimated that

as many as 60% of all SLE patients have clinical LN requiring treatment.

Unlike SLE, LN has straightforward disease outcomes where an early

response correlates with long-term outcomes, measured by proteinuria. In

patients with LN, renal damage results in proteinuria and/or hematuria

and a decrease in renal function as evidenced by reduced estimated

glomerular filtration rate (eGFR), and increased serum creatinine

levels. LN is debilitating and costly and if poorly controlled, LN can

lead to permanent and irreversible tissue damage within the kidney,

resulting in end-stage renal disease (ESRD), thus making LN a serious

and potentially life-threatening condition.

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 lupus nephritis (LN). The company is headquartered in

Victoria, BC and focuses its development efforts globally. www.auriniapharma.com

Forward Looking Statements

This press release contains

forward-looking statements, including statements related to Aurinia's

regulatory strategy (including plans to meet with the U.S. Food and Drug

Administration to discuss these data and the voclosporin's subsequent

clinical development and path to registration in LN), Aurinia's

analysis, assessment and conclusions of the results of the AURION

clinical study, and the efficacy and commercial potential of

voclosporin. It is possible that such results or conclusions may change

based on further analyses of these data. Words such as "plans,"

"intends," "may," "will," "believe," and similar expressions are

intended to identify forward-looking statements. These forward-looking

statements are based upon Aurinia's current expectations.

Forward-looking statements involve risks and uncertainties. Aurinia's

actual results and the timing of events could differ materially from

those anticipated in such forward-looking statements as a result of

these risks and uncertainties, which include, without limitation, the

risk that Aurinia's analyses, assessment and conclusions of the results