ANNUAL REPORT 2012 - TiGenix

13. Annual Report of the
Board of Directors on the
Consolidated Financial
Statements and the Statutory
Financial Statements
per December 31, 2012
Dear shareholders,
We are pleased to present to you the
consolidated financial statements and the
statutory financial statements for the fiscal
year ended December 31, 2012.
1. MAIN EVENTS IN 2012
In June 2012, TiGenix obtained national
reimbursement in the Netherlands for
ChondroCelect. The reimbursement was
granted retroactively as per January 1, 2011.
This event together with the ramp up in the
Belgium sales had a huge impact in the 2012
sales (increase of 101 % compared to 2011).
In July 2012, TiGenix reported positive results
of the Cx621 Phase I to assess the safety
of intra-lymphatic administration of its
expanded adipose stem cells. Cx621 aims
to capitalise on the benefits of TiGenix´s
proprietary approach of intra-lymphatic
administration to treat autoimmune
disorders.
patients suffering from complex perianal
fistulas. The main objectives of the study
are to demonstrate safety and superior
efficacy over placebo in perianal fistulas
in Crohn’s disease patients after failure
with their previous treatment, in most cases
biologicals, and to confirm the strong safety
and efficacy results from the Phase II trial
completed in 2011. To date, the Company
received approvals from Ethical Committees
or Regulatory Agencies in all 8 participating
countries, which should allow the Company
to accelerate patient enrolment in the study.
In September 2012, the Dutch manufacturing
facility obtained EMA approval for
commercial production of ChondroCelect.
After the successful cGMP inspection by
the Dutch authorities earlier in 2012, it now
obtained the crucial approval from EMA
for the production of ChondroCelect, the
Company’s commercial cell therapy product
for cartilage repair in the knee, in its new
state-of-the-art manufacturing facility in
Geleen (the Netherlands).
In August 2012, the first patient enrolled
in pivotal Phase III trial with lead product
Cx601 in perianal fistulas (ADMIRE-CD). The
trial is a multicenter, randomized, doubleblind,
placebo-controlled Phase III trial of
Cx601 in approximately 200 Crohn’s disease
In November 2012, TiGenix signed a
commercialization agreement for
ChondroCelect in the Middle East with
pharmaceutical marketing and distribution
company Genpharm in Dubai, United Arab
Emirates.
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