Full Press Release Details
Pharmaceuticals Announces Recently Granted Nanomicellar Formulation
Patents in Japan and China for Topical Ophthalmic Administration of
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"
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.
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.
Aurinia Pharmaceuticals Inc.
Zaruby, 250-708-4293
President & Chief Executive Officer
R. Martin, 250-708-4272
Chief Operating Officer