ANNUAL REPORT 2012 - TiGenix

or the relevant manufacturing processes
or facilities not meeting applicable
requirements. Any such delay or denial is
likely to have a significant impact on the
Company’s operations and prospects, in
particular on its expected revenues.
Regulatory authorities, including the FDA,
the EMA and other regulatory bodies, may
disagree with the Company’s interpretations
of data from pre-clinical studies and clinical
trials. Regulatory authorities also may approve
a product for narrower indications than
requested or may grant approval subject to
the performance of post-marketing studies
for a product. There can be no guarantee
that such post-approval studies, if required,
will corroborate the results of earlier trials.
Furthermore, the market use of such products
may show different safety and efficacy
profiles to those demonstrated in the trials on
which marketing approval was based. Such
circumstances could lead to the withdrawal
or suspension of marketing approval for
the product, which could have a material
adverse effect on the Company’s business,
financial condition, operating results or cash
flows. In addition, regulatory authorities may
not approve the labelling claims that are
necessary or desirable for the successful
commercialisation of the Company’s products.
In addition, a marketed product continues
to be subject to strict regulation after
approval. Changes in applicable legislation
and/or regulatory policies or discovery of
problems with the product, production
process, site or manufacturer may result in
delays in bringing products to the market,
the imposition of restrictions on the product’s
sale or manufacture, including the possible
withdrawal of the product from the market,
or may otherwise have an adverse effect on
TiGenix’s business.
The failure to comply with applicable
regulatory requirements can, among other
things, result in criminal and civil proceedings
and lead to imprisonment, fines, injunctions,
damages, total or partial suspension of
regulatory approvals, refusal to approve
pending applications, recalls or seizures of
products and operating and production
restrictions.
There can be no assurance that regulatory
clearance for trials at each stage, and
approval for the Company’s products and
product candidates still in development,
will be forthcoming without delay or at all. If
TiGenix fails to obtain or maintain regulatory
approval for its products, it will be unable to
market and sell such products. Any delay in,
or failure to receive or maintain, approval
for any of TiGenix’s products could prevent it
from ever generating meaningful revenues or
achieving profitability.
As part of the market authorisation of
ChondroCelect within the European Union,
the CAT and the CHMP have required the
Company to submit a risk management
plan for ChondroCelect with a series of
measures, including further studies to ensure
that the efficacy and the safety are followed
up in a robust manner once in the market.
TiGenix cannot guarantee that as a result
of these studies it will continue to meet the
required efficacy and safety request for
ChondroCelect and hence that it will maintain
its central European Marketing Authorisation.
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