Aurinia Announces Long-Term Manufacturing Collaboration Agreement with Lonza for Clinical and Commercial Supply of Voclosporin VICTORIA, British Columbia--(BUSINESS WIRE)

Announces Long-Term Manufacturing Collaboration Agreement with Lonza for

Clinical and Commercial Supply of Voclosporin

VICTORIA, British Columbia--(BUSINESS WIRE)--December 19, 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 it has entered into a

long-term agreement with Lonza for the manufacture of voclosporin active

pharmaceutical ingredient (API).

This agreement follows a successful multi-year clinical manufacturing

relationship where the companies have been refining the process and

analytical methods to produce clinical and commercial supplies of

Under the terms of the agreement, Lonza agrees to produce cGMP-grade

voclosporin drug substance for use in Aurinia's Phase III lupus

nephritis (LN) clinical program and for future commercial use. The

agreement also provides an option to have Lonza exclusively supply API

"Throughout the company's long relationship with Lonza, we have

developed substantial proprietary know-how in manufacturing commercial

scale voclosporin. We believe this know-how has the potential to broaden

our exclusivity position for voclosporin and ensure high quality,

reliable production of the API," said Lawrence Mandt, VP Regulatory and

"Our partnership with Lonza is the culmination of years of collaboration

in which we have optimized the complex manufacturing process for

voclosporin," said Charles Rowland, Chief Executive Officer of Aurinia.

"As we prepare to advance voclosporin into an LN Phase III program, we

are investing in the infrastructure to deliver this important therapy to

patients living with this devastating disease."

"We're looking forward to further developing our partnership with

Aurinia to supply this innovative medicine to lupus nephritis patients

around the world," said Gordon Bates, Senior Vice President, Business

Unit Head, Chemical and Microbial Manufacturing for Lonza.

"As Voclosporin requires a complex manufacturing process, our expertise

in scaling multi-step synthesis at clinical and commercial scale allows

us to support Aurinia to and through Phase III clinical trials," he

added. "This latest agreement further demonstrates Lonza's commitment to

developing customized supply solutions for our customers as they meet

some of the greatest challenges in patient treatment, in this case for

lupus nephritis patients around the world."

Lonza is one of the world's leading and

most-trusted suppliers to the pharmaceutical, biotech and specialty

ingredients markets. We harness science and technology to create

products that support safer and healthier living and that enhance the

overall quality of life. Not only are we a custom manufacturer and

developer, Lonza also offers services and products ranging from active

pharmaceutical ingredients and stem-cell therapies to drinking water

sanitizers, from the vitamin B compounds and organic personal care

ingredients to agricultural products, and from industrial preservatives

to microbial control solutions that combat dangerous viruses, bacteria

and other pathogens. Founded in 1897 in the Swiss Alps, Lonza today is a

well-respected global company with more than 40 major manufacturing and

R&D facilities and approximately 9,800 full-time employees worldwide.

The company generated sales of about CHF 3.8 billion in 2015 and is

organized into two market-focused segments: Pharma&Biotech and Specialty

Ingredients. Further information can be found at www.lonza.com

Voclosporin, an investigational drug,

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

with clinical data in over 2,000 patients across 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

manufacturing know-how, capabilities and strategy and potential clinical

and commercial supplies of voclosporin. It is possible that such results

or conclusions may change. Words such as "plans," "intends," "may,"

"will," "believe," and similar expressions are intended to identify

forward-looking statements. These forward-looking statements are based