UCB SA - BNP Paribas Fortis

If any of the UCB Group’s major products were to become subject to problems such as loss of patent
protection, changes in prescription growth rates, material product liability litigation, unexpected side
effects, manufacturing difficulties, regulatory proceedings and actions, significant product recalls, major
changes in healthcare structures, publicity affecting doctor or patient confidence or pressure from
existing competitive products, changes in labelling or if a new, more effective treatment should be
introduced, the adverse impact on the UCB Group’s revenues could be significant. In addition, the
UCB Group’s revenues could be significantly impacted by the timing and rate of commercial
acceptance of key new products including Cimzia®, Neupro® and Vimpat®.
(d) There are risks associated with the technical and clinical development of products of the UCB
Group.
The development of pharmaceuticals carries significant risk, and failure may occur at any stage during
development due to quality, safety or clinical efficacy issues. After marketing approvals have been
received, safety issues which may not have surfaced in the comparably small patient populations studied
during clinical trials can result in label restrictions and, in the worst case, to the withdrawal of the drug
from the market. All drug candidates of the UCB Group will need extensive quality, pre-clinical and
clinical testing before an application can be made for market authorisation from regulatory authorities.
It cannot be predicted with certainty if or when the UCB Group will be able to submit an application to
the regulatory authorities of the relevant markets.
Each individual development step is associated with the risk of failure, hence an early stage drug
candidate carries a considerably higher accumulated risk of failure than a later stage candidate, but the
risk nonetheless is high even at the latest stage. The statistical chance of success is increasing as drug
candidates progress successfully through the different phases of drug development. It is probable that
not all the programmes in the pipeline of the UCB Group will succeed.
Human clinical trials are very expensive and difficult to design and implement, in part because such
trials are subject to rigorous regulatory requirements. Clinical trials are also very time consuming and
can take several years to complete for each product candidate. Failure can occur at any stage of the
trials and problems may be encountered that would cause the UCB Group to interrupt, abandon or
repeat clinical trials. The commencement and completion of clinical trials may be delayed or hindered
by several factors, including but not limited to:
• difficulties in obtaining regulatory and/or ethics committee approval of the study protocol;
• fewer than the projected number of suitable investigators, which will result in delayed
recruitment of the required number of patients;
• unexpected safety and tolerability issues;
• issues with identifying the appropriate therapeutic dosage range;
• unexpected issues with respect to the supply of investigational products; and
• unfavourable benefit/risk ratio due to safety data collected in the course of clinical
development.
Every clinical trial requires a pre-specified objective and clearly defined primary goal. The hypothesis
which is to be tested in the clinical trial may be proven wrong. This will result in a negative study
outcome. Clinical studies which have not met their primary goal are usually not suitable to support a
regulatory submission. If clinical trials for a drug candidate should be unsuccessful, the UCB Group
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