UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13A-16 OR 15D-16 UNDER THE
SECURITIES
EXCHANGE ACT OF 1934
Dated
March
6, 2017
Commission
File Number 001-36421
AURINIA PHARMACEUTICALS INC.
(Exact
name of Registrant as specified in its charter)
N/A
(Translation of Registrant’s Name)
#1203-4464 Markham Street
Victoria, British Columbia
V8Z7X8
(250)
708-4272
(Address and telephone number of registrant’s
principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ⃞ Form 40-F ⊠
Indicate by
check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1): ⃞
Indicate by
check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ⃞
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ⊠ No ⃞
This Form 6-K is hereby filed and incorporated by reference into the Registrant’s Registration Statement on Form F-10 (File No. 333-206994).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Dated: |
March 6, 2017 |
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Aurinia Pharmaceuticals Inc. |
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By: |
/s/ Celia Economides |
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Name: |
Celia Economides |
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Title: |
Head of IR & Communications |
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EXHIBIT INDEX
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Exhibit |
Description of Exhibit |
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| 99.1 |
News Release – AURINIA ANNOUNCES ACCEPTANCE OF VOCLOSPORIN LATE-BREAKING PRESENTATION AT THE NATIONAL KIDNEY FOUNDATION 2017 SPRING CLINICAL MEETINGS |
Exhibit 99.1 included with this report on Form 6-K is hereby incorporated by reference as an exhibit to the Registrant’s Registration Statement on Form F-10 (File No. 333-206994), as amended or supplemented.
3
Exhibit 99.1
Aurinia Announces Acceptance of Voclosporin Late-Breaking Presentation at the National Kidney Foundation 2017 Spring Clinical Meetings
VICTORIA, British Columbia--(BUSINESS WIRE)--March 6, 2017--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 its late-breaking abstract for voclosporin has been accepted for oral presentation at the National Kidney Foundation (NKF) 2017 Spring Clinical Meetings taking place April 18-22, 2017 in Orlando, FL. The oral presentation, titled “Treatment of Active Lupus Nephritis with Voclosporin: 48 Week Data from the AURA-LV Study,” will be made by lead author Dr. Samir Parikh, a clinical investigator for the study and Assistant Professor, Clinical Nephrology at the Ohio State University, on Thursday, April 20, 2017 from 4:00 p.m. – 5:30 p.m. ET.
A corresponding Late Breaking poster presentation of the 48-week AURA-LV study data will also be presented at the NKF 2017 Scientific Clinical Meetings. A copy of the abstract will be available on the conference’s website at: https://www.kidney.org/spring-clinical.
"We're pleased that the AURA-LV 48-week data have been accepted for a late-breaking oral presentation and look forward to sharing these important results with the nephrology scientific and medical communities," said Richard M. Glickman, Aurinia’s Chief Executive Officer.
About AURA-LV
The AURA–LV study (Aurinia Urinary
protein Reduction in Active Lupus with Voclosporin) is a 48-week study
comparing the efficacy of two doses of voclosporin added to current
standard of care of MMF against standard of care with placebo in
achieving CR in patients with active LN. All arms also received low
doses of corticosteroids as background therapy. 265 patients were
enrolled at centers in 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. The
24-week primary and secondary endpoints were released in Q3 2016 where
the primary and all secondary endpoints were met. CR is a composite
endpoint that includes: confirmed UPCR of ≤0.5 mg/mg; normal, stable
renal function (≥60 mL/min/1.73m2 or no confirmed
decrease from baseline in eGFR of ≥20%); presence of sustained, low dose
steroids (≤10mg prednisone from week 16-24); and no administration of
rescue medications. PR in the trial is measured by a ≥50% reduction in
UPCR with no concomitant use of rescue medication.
About Voclosporin
Voclosporin, an investigational drug,
is a novel and potentially best-in-class calcineurin inhibitor (“CNI”)
with clinical data in over 2,200 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
other countries.
About Lupus Nephritis (LN)
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.
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 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
ability to execute a successful Phase III program and voclosporin
potentially shifting the treatment paradigm for LN, Aurinia's analysis,
assessment and conclusions of the results of the AURA-LV clinical study.
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,
except as required by law.
CONTACT:
Aurinia Pharmaceuticals Inc.
Investor Contact:
Celia
Economides
Head of IR & Communications
ceconomides@auriniapharma.com
or
Media
Contact:
Christopher Hippolyte, 917-826-2664
Christopher.hippolyte@inventivhealth.com