0001157523-15-000347.txt : 20150204 0001157523-15-000347.hdr.sgml : 20150204 20150203205516 ACCESSION NUMBER: 0001157523-15-000347 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20150203 FILED AS OF DATE: 20150204 DATE AS OF CHANGE: 20150203 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Aurinia Pharmaceuticals Inc. CENTRAL INDEX KEY: 0001600620 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36421 FILM NUMBER: 15573266 BUSINESS ADDRESS: STREET 1: #1203-4464 MARKHAM STREET CITY: VICTORIA BC STATE: A1 ZIP: V8Z 7X8 BUSINESS PHONE: 250-708-4272 MAIL ADDRESS: STREET 1: #1203-4464 MARKHAM STREET CITY: VICTORIA BC STATE: A1 ZIP: V8Z 7X8 6-K 1 a51032706.htm AURINIA PHARMACEUTICALS INC. 6-K

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 February 3, 2015

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 principle 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  

If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): Not applicable



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.

Dated:

February 3, 2015

 

Aurinia Pharmaceuticals Inc.

 

 

 

By:

/s/ Michael R. Martin

Name:

Michael R. Martin

 

 

Title:

Chief Operating Officer

2

EXHIBIT INDEX

Exhibit

 

Description of Exhibit

 
99.1

News Release – Aurinia Pharmaceuticals announces recently granted nanomicellar formulation patents in Japan and China for topical ophthalmic administration of voclosporin

3

EX-99.1 2 a51032706ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

Aurinia Pharmaceuticals Announces Recently Granted Nanomicellar Formulation Patents in Japan and China for Topical Ophthalmic Administration of voclosporin

VICTORIA, British Columbia--(BUSINESS WIRE)--February 3, 2015--Aurinia Pharmaceuticals Inc. (the “Company”) (NASDAQ:AUPH / TSX:AUP) today announced that the Company has recently been granted patents by the Japanese and Chinese patent offices for its nanomicellar formulation of voclosporin. These are in addition to multiple other patents that have been issued and granted in the United States, Mexico and Australia for ophthalmic administration of voclosporin. Further patent prosecution in other regions is ongoing.

“We are very excited about the potential for ocular administration of voclosporin utilizing this unique nanomicellar drug delivery technology. This formulation enables high concentrations of voclosporin to be put into solution for local delivery to the ocular surface” said Stephen Zaruby, President & CEO of Aurinia Pharmaceuticals Inc.

Completed preclinical and phase I studies using this nanomicellar technology in combination with voclosporin have shown encouraging results in terms of delivery of active drug to target tissues. In addition this nanomicellar formulation of voclosporin has the potential to improve dosing frequency and tolerability.

“Ophthalmic nanomicellar voclosporin has the potential to compete in the billion dollar prescription dry eye market currently dominated by Restasis® (Cyclosporin ophthalmic emulsion 0.05%) with what appears to be a very competitive product profile” said Neil Solomons, MD, Chief Medical Officer of Aurinia Pharmaceuticals Inc.

“The Company plans to review its strategic options as it relates to this ophthalmic formulation of voclosporin and the nanomicellar delivery technology including but not limited to outlicensing or divestiture while at the same time remaining focused on our lupus nephritis program” said Mr. Zaruby.

About Aurinia

Aurinia is a clinical stage pharmaceutical company focused on the global nephrology market. It is currently enrolling patients in its Phase 2b clinical trial to evaluate the efficacy of its drug, voclosporin, as a treatment for lupus nephritis (“LN”). LN is an inflammation of the kidneys, that if inadequately treated can lead to end-stage renal disease, making LN a serious and potentially life-threatening condition.

Voclosporin is a novel and potentially best in class calcineurin inhibitor (“CNI”) with extensive clinical data in over 2,600 patients in other indications. Voclosporin is made by a modification of a single amino acid of the cyclosporine molecule (a CNI approved for use in transplant patients since 1983). This modification results in a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency vs. cyclosporine, an altered metabolic profile, and potential for flat dosing.

Aurinia also has development and commercialization partners in Canada, Israel, South Africa and Greater China. Visit www.auriniapharma.com, www.sedar.com and www.sec.gov for more information.

About Restasis®

Restasis® (cyclosporin ophthalmic emulsion 0.05%) was approved by the U.S. Food and Drug Administration in December 2002 to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with chronic dry eye.

Restasis® is a registered trademark of Allergan Inc.

CONTACT:
Company:
Aurinia Pharmaceuticals Inc.
Stephen Zaruby, 250-708-4293
President & Chief Executive Officer
szaruby@auriniapharma.com
or
Michael R. Martin, 250-708-4272
Chief Operating Officer
mmartin@auriniapharma.com