Full Press Release Details
Reports First Quarter 2016 Financial Results and Operational Highlights
completed in Phase 2b clinical trial with data read out in third quarter
Fast Track designation granted to voclosporin for lupus nephritis
AURION results support the use of voclosporin as a component of
multi-targeted therapy in lupus nephritis
leadership team strengthened with expanded capabilities
VICTORIA, British Columbia--(BUSINESS WIRE)--May 11, 2016--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH)(TSX:AUP) ("Aurinia" or the "Company")
has released its financial results for the first quarter ended March 31,
2016. Amounts, unless specified otherwise, are expressed in U.S. dollars.
The first quarter of 2016 was highlighted by the completion of patient
enrollment in our Phase 2b (AURA) clinical trial and obtaining fast
track designation from the FDA for voclosporin. In addition to these
clinical and regulatory successes, the Company received promising data
from the open-label AURION study that further supports our hypothesis on
the potential for multi-targeted therapy with voclosporin for the
treatment of lupus nephritis (LN). The team is focused on preparations
for the AURA primary end point data release in the latter half of the
third quarter of 2016 and initiation of the Phase 3 program in 2017. The
Company is making the necessary investments now to ensure the team has
the tools to deliver future success. The remainder of the year will also
see further data releases from the AURION study including some 24 and 48
The Company will also be completing assessments of key markets in the
Americas, Europe and Asia. The Company will share more on these
developments during future investor presentations.
"While only being in this role a short time, I am both excited and
greatly encouraged by the performance and focus of the team. I plan to
continue to execute on initiatives to maximize shareholder value and
help bring a desperately needed therapy to market for patients suffering
from LN." said Charlie Rowland, CEO of Aurinia Pharmaceuticals Inc.
AURA Phase 2b Clinical Trial Update - Patient Enrollment Completed
On January 19, 2016, the Company announced completion of patient
enrollment of its AURA clinical trial at 265 patients. This Phase 2b
trial, is a randomized, controlled, double-blind study comparing the
efficacy of voclosporin as a component of multi-targeted therapy against
placebo in achieving remission in patients with active lupus nephritis
(LN). AURA is one of the largest prospective registration-quality
studies ever conducted within this specific disease area.
On March 2, 2016 the Company announced that the U.S. Food and Drug
Administration (FDA) granted Fast Track designation for voclosporin, the
Company's next generation calcineurin inhibitor, for the treatment of LN.
The Fast Track program was created by the FDA to facilitate the
development and expedite the review of new drugs that are intended to
treat serious or life-threatening conditions and that demonstrate the
potential to address significant unmet medical needs. Compounds that
receive this FDA designation benefit from more frequent meetings and
communications with the FDA to review the drug's development plan
including the design of clinical trials and the use of biomarkers to
support approval. Additionally, Fast Track designation allows the
Company to submit parts of the New Drug Application (NDA) on a rolling
basis for review as data becomes available. The Company expects to
analyse and review the AURA data with the FDA later in 2016 in order to
determine the appropriate next steps.
On February 8, 2016 the Company announced that it had completed a
preliminary analysis of its AURION (Aurinia early Urinary
protein Reduction Predicts Response) study. In the first
seven patients, of the 10 patients enrolled in the study, that have
reached at least eight weeks of therapy in the AURION study, 100% (7/7)
achieved at least a 25% reduction in proteinuria compared to study
entry. A 25% reduction in proteinuria at eight weeks has been shown to
be predictive of a positive clinical response at 24 weeks1.
Additionally, in the first eight weeks of the open-label AURION study an
overall mean reduction of proteinuria of 72% compared to pre-treatment
levels was observed, and 57% (4/7) of these patients achieved complete
remission as defined by a urinary protein creatinine ratio of
0.5mg/mg. Overall renal function as measured by eGFR in these patients
also remained stable. The Company plans to release further AURION data
as it becomes available.
Strengthening Leadership and Capabilities
On April 11, 2016 the Company appointed Mr. Charles A. Rowland, Jr.,
MBA, CPA, as its Chief Executive Officer. Mr. Rowland has more than 30
years of experience in pharmaceutical operations, strategic value
creation as well as financial management. He served as the Vice
President and Chief Financial Officer of ViroPharma Incorporated, an
international biopharmaceutical company, until it was acquired by Shire
plc for $4.2B in January 2014. As a member of the executive team, he was
key to developing the global strategic direction of the company, its
international expansion and its strong financial position.
On April 29, 2016 the Company appointed Bradley J. Dickerson as an
officer of the Company in the position of General Manager of the
Americas and Global Commercial Assessment. Mr. Dickerson has more than
15 years of experience in the healthcare industry with a focus on
pharmaceutical market access, distribution and patient services. He
served as Vice President, Access and Reimbursement at NPS
Pharmaceuticals, until it was acquired by Shire plc. Prior to his role
at NPS, Mr. Dickerson was Director of Managed Markets at ViroPharma with
responsibility for all market access functions. He also provided
leadership for the launch and ongoing commercialization of Cinryze .
Expected Upcoming Milestones and Events
AURION 10 patients to 8 weeks - Q2/2016
AURION 7 patients to 24 weeks - Q2/2016
AURA-LV 24 week primary end-point data release - Q3/2016
AURION 10 patients to 24 weeks - Q3/2016
Filing for Breakthrough Designation - Q3/2016-pending data from AURA
trial - 24 week results
Investor Day-Fall/2016
End of Phase 2 meeting with FDA - Q4/2016
Scientific meetings:
Abstract presentation - European Renal Association / European
Dialysis and Transplantation Meeting (ERA/EDTA) -Q2/2016