ANNUAL REPORT 2012 - TiGenix

6.4.5. Commercial launch
ChondroCelect is the first cell-therapy
product in Europe that is commercialized as
a medicinal product, and is positioned as
a first-in-class medicinal product for knee
cartilage regeneration that offers a proven
durable treatment effect.
Following central approval the
Company pursues a staged strategy for
ChondroCelect’s market launch in the
European Union with national and regional
reimbursement agreements as the most
important drivers for success.
TiGenix is focusing on selected centers and
surgeons, many of which have already been
trained and have had the opportunity to use
ChondroCelect in the context of the clinical
trials and/or compassionate use (named
patient) program.
Recognizing the importance of pre-launch
product and therapy awareness and
the need for direct contact with the first
prescribers of ChondroCelect, TiGenix has set
up a high-level commercial core team. The
team consists of about 10 people, covering
a significant part of the market in Western
Europe. TiGenix now has direct commercial
presence in Belgium/the Netherlands/
Luxemburg, the United Kingdom, Germany,
France and Spain. In Finland and the
Middle East, the Company has distribution
agreements in place with the Finnish Red
Cross Blood Service (FRCBS) and Genpharm
respectively. As the company expands to
other markets, it will each time determine
developing these markets with its own direct
sales force, possibly assisted by selected local
agents, or consider entering into distribution
arrangements.
The direct core team is composed of a mix
of professionals with different backgrounds
and experience in the pharmaceutical
and medical device industries reflecting
the particular requirements for successfully
marketing innovative medicinal cell
therapy products, and covers four
closely collaborating functions : therapy
development and customer support,
market access, pricing and reimbursement,
and marketing. The commercial team is
further supported by scientific and medical
experts from the Clinical and Medical Affairs
departments.
In 2012, ChondroCelect sales amounted to
EUR 4,1 million. Belgium and the Netherlands
(both under reimbursement) represented
85 % of the total sales, while the United
Kingdom, Germany and Spain, through a
variety of pre-reimbursement mechanisms,
represented 15 % of the total sales, which
shows that positive reimbursement
decisions are an important condition for
increases in sales. In case no further positive
reimbursement decisions would be obtained,
the Company expects only a limited increase
in sales due to the fact that the countries
where reimbursement is already obtained
are rather small markets.
6.4.6. Market access and reimbursement
Pricing and reimbursement are not
harmonized in Europe and fall within the
exclusive competence of the national
authorities. Reimbursement mechanisms
by private and public health insurers vary
from country to country, and are sometimes
even regionally determined. In public
health insurance systems, reimbursement is
determined by procedures established by
the competent authority of the EU member
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