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Tuesday, 04/11/2017 11:26:15 AM

Tuesday, April 11, 2017 11:26:15 AM

Post# of 17454
Excerpt fro the Cantor report:

What We Like …
? First successful outcome in a large global randomized lupus nephritis trial.
? Voclosporin achieved unprecedented complete remission rates at both 24-weeks and
48-weeks with its best performing 23.7mg BID dose, compared to placebo (P = 0.045
and P < 0.001, respectively).
? These results were achieved in concert with a rapid and meaningful taper of
background corticosteroids down to ≤ 2.5mg/day.
? Despite unexpected mortality events raising some initial concerns, the broad safety
package of voclosporin is encouraging relative to competitive agents in
development or those used off-label.
? We believe voclosporin could generate revenue of $1.6 billion when reaching peak
market penetration of 20% in the U.S. alone.
? Management brings exceptional expertise in both the development of voclosporin and
clinical studies for the treatment of lupus nephritis.
? Significant experience with development of voclosporin, both for tolerability in
fragile lupus patients and identifying appropriate levels of immunosuppression to
achieve efficacy.
? Members of management originating from the Aspreva Lupus Management Study
(ALMS) conducted the last study to meaningfully shift the treatment paradigm
in LN, in our view.
? Single pivotal Phase 3 AURORA study is well positioned for success.
? The successful Phase 2b AURA-LV study was a 48-week study conducted in 265
patients, marginally smaller than the planned 320-patient 52-week Phase 3 AURORA
study.
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