ANNUAL REPORT 2012 - TiGenix

Fig. 3 : Overview of estimated patient population suffering from complex perianal fistula
Patient Pool for fistulas in Europe : 507.470.000
(EU 27 + Norway, Switzerland, Lichtenstein and monaco)
Patient Pool for fistulas in USA : 302.200.000
0,1045 % 0,162 %
Crohn’s disease
Cases per year = 530.306
Crohn’s disease
Cases per year = 489.564
12 % 12 %
Perianal fistulas
Cases per year = 63.317
Perianal fistulas
Cases per year = 58.748
80 % 20 % 80 %
20 %
Complex fistulas
# of cases = 50.910
Simple fistulas
# of cases = 12.727
Complex fistulas
# of cases = 46.998
Simple fistulas
# of cases = 11.750
Taking into consideration a target population
as described above and an estimated sales
price range of KEUR 20 - 24, Cx601’s market
size could be estimated to be around EUR
1 billion for Europe and North-America
combined.
the biological drug Remicade ® (Infliximab).
Both offer poor outcomes and in many
instances notable side effects such as the
reactivation of tuberculosis and increased
risk of infection with Aspergillus, Listeria and
Cryptococcus.
For Crohn´s patients with complex perianal
fistulas, currently, treatments of choice
are antibiotics and azathioprine or
6-mercaptopurine as first-line therapy, and
The table below gives an overview of the
most common treatments for perianal fistulas
in Crohn’s disease patients with a brief
description of their main characteristics :
Antibiotics
Immunosuppressants
Antibiotics
+ immunesuppressants
Biologicals
Use
First line or
adjuvant therapy
to treat infections
and abscess from
fistula.
Azatioprine and
6-mercaptopurine
used as first line
after antibiotics
therapy.
Antibiotics and
immunosuppresors
often used in
combination as first
line therapy.
Second line.
Remicade ®
(Infliximab) is the
only approved
biologic drug for
fistulizing Crohn’s.
Evaluation
Seem to be useful
if used short term
or intermittently
but adverse
effects result from
prolonged use.
Very low efficacy in
fistula closure but
often reduction
of inflammation,
discharge and
discomfort.
Low efficacy and
a high rate of
relapse.
Some efficacy
in fistula closure.
However,
recurrence is
almost assured
when Infliximab is
stopped. Serious
side effects known.
The burden of the perianal fistula in Crohn´s disease is high, both to the individual patient and
to the health care provider. In financial terms the most significant portion of the cost burden of
diagnosis and treatment can be attributed to the pharmaceutical treatment. A recent study
conducted by IMS (independent provider of market research) on behalf of TiGenix, concluded
66 TiGenix I annual report 2012