FWP 1 d575206dfwp.htm FWP PRESENTATION FWP presentation
Issuer Free Writing Prospectus
Filed Pursuant to Rule 433
Registration No. 333-189395
July 29, 2013


2
EXPLANATORY NOTE:
The
attached
pages
update
the
corporate
presentation
filed
as
an
issuer
free
writing
prospectus
on
July
22,
2013:
Slide
16,
number
of
patients
identified
above
the
left
graph
for
Percent
Brain
Volume
Change
at
Week
52:
n=32 corresponds with bar showing -0.04 percent brain volume change; and
n=18 corresponds with bar showing -0.32 percent brain volume change.
[Note:  the corporate presentation prior to this update
had the patient numbers (i.e.,
n=32 and n=18) reversed.]
Slide
16,
number
of
patients
identified
below
the
right
graph
for
Annualized
Relapse
Rate
(ARR)
at
Week
52: 
n=32 corresponds with bar showing 0.28 ARR; and
n=18 corresponds with bar showing 0.63 ARR.
[Note:  the corporate presentation prior to this update
had the patient numbers (i.e.,
n=32 and n=18) reversed.]
Slide
17,
ARR
below
the
middle
graph
is
>
1.
[Note:
the
corporate
presentation
prior
to
this
update
reflected     
“>1”
rather than “>1.”]
Slide
22,
65
patients
were
enrolled
in
the
Abili-T
trial
at
July
19,
2013.
[Note:
the
corporate
presentation
prior
to
this
update
reflected
53
patients
enrolled
at
June
14,
2013.]


3
TERMS Study -
Prospective Analysis in
More Active or Progressive Patients
Sub-population of patients (n=50) with more progressed/active disease profile (baseline
ARR >1) most closely mirrors SPMS patients
88% Reduction in
Brain Atrophy
Percent Brain Volume Change
at Week 52
Statistically Significant
Improvement in Disability (p=0.045)
55% Reduction in ARR
Annualized Relapse Rate (ARR)
at Week 52
Change in Disability (EDSS)
at Week 52
These
Data
Support
Phase
IIb
Program
in
SPMS


4
TERMS Study -
Subgroup Analysis
in Patients Naïve to DMT
Annualized relapse rate in DMT naïve populations.  ARR in placebo subjects without previous disease modifying
treatment (DMT) experience reflects relapse rates commonly seen in other placebo controlled trials in MS. In this
subpopulation,
treatment
with
Tcelna
resulted in a
56–73% reduction  in ARR compared with  placebo.
64% Reduction
p=0.046
73% Reduction
p=0.009
56% Reduction
p=0.060
n=25
n=45
n=8
n=16
n=28
n=53
mITT
ARR > 1
ARR>1
Tcelna
Placebo
0
0.2
0.4
0.6
0.8
1
1.2
1.4
0.21
0.18
0.31
0.48
0.5
1.18


5
Abili-T
: Landmark trial in SPMS
Abili-T Phase IIb clinical trial in SPMS is ongoing
Double-blind, 1:1 randomized, placebo-controlled
Inclusion criteria: Secondary Progressive MS with EDSS of 3 to 6
65 patients enrolled at July 19, 2013
Immune Monitoring program conducted on a blinded basis
Fast Track designation granted by FDA for Tcelna in SPMS
180 Patients expected to be enrolled
SPMS population
30 sites in USA and Canada
2 annual courses of personalized therapy