Aurinia Announces That Voclosporin Achieves Primary and All Pre-Specified Secondary Endpoints in Its Phase IIb AURA-LV Study for Lupus Nephritis (LN) AURA-LV is the first global active LN study to meet its primary endpoi

Announces That Voclosporin Achieves Primary and All Pre-Specified

Secondary Endpoints in Its Phase IIb AURA-LV

Study for Lupus Nephritis (LN)

is the first global active LN study to meet its primary endpoint and

all of its 24-week pre-specified secondary endpoints

mortality review concludes that deaths in the AURA-LV study appear to

be unrelated to study drug and consistent with complications of LN

efficacy and safety analyses from the AURA study will be presented and

webcast live on Friday, September 30th

VICTORIA, British Columbia--(BUSINESS WIRE)--September 29, 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 that in addition to

voclosporin (23.7 mg BID) achieving its primary endpoint of Complete

Remission (CR) at 24 weeks, both doses of voclosporin when added to the

current standard of care of Mycophenolate Mofetil (MMF) and a forced

oral corticosteroid taper have met all 24-week pre-specified secondary

endpoints vs the control group. These pre-specified endpoints include:

Partial Remission (PR), which is measured by a 50% reduction in UPCR

with no concomitant use of rescue medication; time to CR and PR;

reduction in Systemic Lupus Erythematosus Disease Activity Index or

SLEDAI score; and reduction in UPCR over the 24-week treatment period.

All p-values are vs control

The AURA-LV study remains ongoing to its 48-week endpoint upon which

similar and additional secondary analysis will be analysed and presented

"We are thrilled by the results of the AURA study and voclosporin's

potential to shift the treatment paradigm for active lupus nephritis,"

said Charles Rowland, CEO of Aurinia. "The ability to get more patients

into remission and in a shorter period time than the current standard of

care can have a significant impact on the long-term outcomes for these

"LN is a serious and devastating disease that can severely impact a

patient's life," said William Pendergraft, MD, PhD, Assistant Professor

of Medicine in the Division of Nephrology & Hypertension, at the

University of North Carolina and a Principal Investigator in the study.

"Voclosporin has demonstrated it can nearly double the number of

patients that achieve Complete Remission in the presence of very low

corticosteroid exposure. Based on these data, I believe this drug has

the potential to significantly improve the long-term prognosis of my

patients afflicted with LN and could become an integral component of the

The Company will present the full efficacy (including pre-specified and

ad hoc sub-analyses) and comprehensive safety data during a webcast

presentation to be held at 8:00am ET. A link to the live webcast and

slides will be available on the Investors section of the Company's

website at http://www.auriniapharma.com.

The AURA-LV study or "Aurinia Urine

Protein Reduction in Active Lupus Nephritis Study" compared the efficacy

of voclosporin added to current standard of care of mycophenolate

mofetil (MMF, also known as CellCept ) against standard of care with

placebo in achieving complete remission (CR) in patients with active LN.

Both arms also received low doses of corticosteroids as background

therapy. It enrolled 265 patients at centers in over 20 countries

worldwide. On entry to the study, patients were required to have a

diagnosis of LN according to established diagnostic criteria (American

College of Rheumatology) and clinical and biopsy features indicative of

highly active nephritis.

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