Exhibit 99.1
Aurinia Announces Acceptance of Late-Breaking Voclosporin Abstracts for Oral Presentation at Upcoming Medical Meetings
VICTORIA, British Columbia--(BUSINESS WIRE)--October 24, 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 two late-breaking abstracts for voclosporin were accepted for oral presentations at the ACR/ARHP Annual Meeting taking place in Washington, D.C. November 11-16, 2016, and ASN Kidney Week taking place in Chicago November 15-20, 2016.
“The selection of voclosporin data for two late-breaking oral presentations at key medical meetings underscores the importance of providing the medical community with new information about therapy advancements in the treatment of lupus nephritis,” said Neil Solomons, M.D., Aurinia’s Chief Medical Officer. “Data presented highlights Aurinia’s commitment to providing lupus nephritis patients with a tolerable and effective treatment option, improving long-term patient outcomes and quality of life.”
The schedule for the oral presentations is as follows:
Session: Late-Breaking Oral Abstracts
Speed of Remission
with the Use of Voclosporin, MMF & Low Dose Steroids: Results of a
Global Lupus Nephritis Study
Conference: 2016 ACR/ARHP Annual
Meeting
Date/Time: November 15, 2016, 4:30-6:00 p.m.
Presented by:
Mary Anne Dooley, M.D., M.P.H., Adjunct Professor of Medicine,
University of North Carolina Kidney Center
Presentation Number: 5L
Session: High Impact Clinical Trials
AURA-LV: Successful
Treatment of Active Lupus Nephritis with Voclosporin
Conference:
ASN Kidney Week 2016 Annual Meeting
Date/Time: November 19, 11:50 a.m.
Presented
by: William Pendergraft, M.D., Ph.D., Assistant Professor of Medicine in
the Division of Nephrology & Hypertension at the University of North
Carolina
Abstract Number: 6480
About AURA-LV
The AURA–LV study (Aurinia Urine protein
Reduction in Active Lupus with Voclosporin) compared the efficacy of two
doses 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.
All arms also received low doses of corticosteroids as background
therapy. 265 patients were enrolled 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.
About Voclosporin
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
other countries.
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 measures 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, 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.
About Aurinia
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. Canada and focuses its development efforts globally. www.auriniapharma.com.
Forward Looking Statements
This press release contains
forward-looking statements, including statements Aurinia's analysis,
assessment and conclusions of the results of the AURA-LV 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 of the AURA-LV clinical study set forth in
this release may change based on further analyses of such data, and the
risk that Aurinia’s clinical studies for voclosporin may not lead to
regulatory approval. These and other risk factors are discussed under
"Risk Factors" and elsewhere in Aurinia’s Annual Information Form for
the year ended December 31, 2015 filed with Canadian securities
authorities and available at www.sedar.com and on Form 40-F with
the U.S. Securities Exchange Commission and available at www.sec.gov,
each as updated by subsequent filings, including filings on Form 6-K.
Aurinia expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in Aurinia's expectations with
regard thereto or any change in events, conditions or circumstances on
which any such statements are based.
CONTACT:
Investor & Media Contact:
Aurinia
Pharmaceuticals Inc.
Celia Economides
Head of IR & Communications
ceconomides@auriniapharma.com