Voclosporin is a calcineurin inhibitor designed to block IL-2 expression and T-cell mediated immune responses, tamping down the autoimmune attack while stabilizing a type of kidney cell that can be damaged in lupus nephritis patients. Presentation contains: Market potential, pipeline, competitor, epidemiology, etc.

1. VOCLOSPORIN All eyes are now on
Voclosporin
Presented By:
VICKY JAIN
MBA PM-11
ROLL: 0217

2. ABOUT
VOCLOSPORIN
SOURCE: Access on March 03, 2020
https://www.drugs.com/history/voclosporin.html
An Investigational drug
An Immunosuppressant
FDA Approved: No
Generic name: Voclosporin
Company: Aurinia Pharmaceuticals Inc.
Treatment for: Lupus Nephritis

3. ABOUT LUPUS
NEPHRITIS
Lupus nephritis is a serious
chronic disease of the immune
system, currently treated
primarily with older nonspecific
and toxic off-label
immunosuppressants and oral
corticosteroids.
No agent is approved for lupus
nephritis in the United States or
Europe, and the level of unmet
need in this area is high.
LUPUS NEPHRITIS
EPIDEMIOLOGY
• In 2005, Incidence was found to be 5.1 (Overall), 1.9 (Adult
men), 8.2 (Adult women).
• The incidence of Lupus nephritis increases with age upto 50
years; the median age at diagnosis is 25 years.
• US: Diagnosed prevalent cases of CKD, stages I to IV in both
sexes are:
In 2016: 55,57,199
In 2026: 68,58,067
• African Americans have a higher frequency of developing
Lupus nephritis in the United States.
• SOURCE: Access on March 03, 2020
1. https://www.wikidoc.org/index.php/Lupus_nephritis_epidemiology_and_demographics
2. https://decisionresourcesgroup.com/blog/voclosporin-lupus-nephritis-going-odds/
3. https://www.clinicaltrialsarena.com/comment/lupus-nephritis-treatment-2019/

4. Until now, no other emerging therapy was able to achieve
what voclosporin accomplished in its development
program—the drug met the primary induction and the
secondary maintenance endpoints assessing complete renal
remission in a global clinical trial in patients with active
lupus nephritis.
MECHANISM
OF ACTION
Voclosporin Forms a Heterodimeric
Complex With Cyclophilin A that
Binds to and Inhibits Calcineurin.
By inhibiting calcineurin, voclosporin
blocks IL-2 expression and T-cell
mediated immune responses and
stabilizes the podocyte in the kidney.
• SOURCE: Access on March 03, 2020
https://decisionresourcesgroup.com/blog/voclosporin-lupus-nephritis-going-
odds/

5. Pipeline
(CLINICAL TRIAL)
SOURCE: Access on March 03, 2020
https://www.auriniapharma.com/pipeline
Currently advancing Voclosporin for:
• The treatment of lupus nephritis
• The treatment of focal segmental glomerulosclerosis
• The treatment of dry eye syndrome (ophthalmic solution )
Candidate & Indication
Development Stage
Phase 1 Phase 2 Phase 3 Market
VOCLOSPORINLUPUS NEPHRITIS (LN)
Phase 1 Phase
complete
Phase 2 Phase
complete
Phase 3 Phase in
progress
Market Phase
not started
VOCLOSPORINFOCAL SEGMENTAL
GLOMERULOSCLEROSIS (FSGS)
Phase 1 Phase
complete
Phase 2 Phase in
progress
Phase 3 Phase not
started
Market Phase
not started
VOCLOSPORIN OPHTHALMIC SOLUTIONDRY
EYE SYNDROME
Phase 1 Phase
complete
Phase 2 Phase in
progress
Phase 3 Phase not
started
Market Phase
not started

6. Regulatory challenges
• The global Phase IIb trial of Voclosporin
in lupus nephritis (AURA-LV;
clinicaltrials.gov, NCT02141672) was
designed to test the performance of two
doses of Voclosporin (23.7 mg and 39.5
mg).
• The trial also raised concerns about its
safety. Thirteen deaths were reported
during the induction stage of the trial (at
24 weeks), with 11 deaths recorded in the
low-dose Voclosporin group alone.
• The next challenge for the company will
be to secure favorable reimbursement
terms with payers in order to optimize
voclosporin’s market potential
• Moving toward value-based healthcare,
robust efficacy in inducing complete renal
remission, coupled with evidence of
voclosporin’s efficacy in corticosteroid
dose reduction.
• Careful pricing considerations will be
essential for a successful launch
• SOURCE: Access on March 03, 2020.
https://decisionresourcesgroup.com/blog/voclosporin-lupus-nephritis-going-odds/

7. MARKET POTENTIAL
• Voclosporin has projected
sales of $2.2bn in 2026.
Aurinia has a market
capitalization of CAD 751m
($570m).
• US: Diagnosed prevalent
cases of CKD, stages I to IV
in both sexes are:
In 2016: 55,57,199
In 2026: 68,58,067
SOURCE: Access on March 03, 2020.
• https://www.clinicaltrialsarena.com/comment/lupus-nephritis-
treatment-2019/

8. COMPETITOR
• GSK’s Benlysta, is a drug that is already
approved for moderate to severe nonrenal
lupus and is currently in a Phase III trial in
patients with lupus nephritis.
• The launch of rituximab biosimilar could
provide physicians with a more-affordable
option of a drug.
• An off-label older calcineurin inhibitor,
tacrolimus, will also compete with
voclosporin.
• Mycophenolate mofetil/oral corticosteroids or
IV cyclophosphamide/oral corticosteroids
regimens), instead of opening its use to
patients who are just starting induction
treatment.
• SOURCE: Access on March 03, 2020.
1. https://www.clinicaltrialsarena.com/comment/lupus-nephritis-treatment-2019
2. https://decisionresourcesgroup.com/blog/voclosporin-lupus-nephritis-going-odds/

9. THANK YOU