UCB SA - BNP Paribas Fortis

that remission is possible with no dose escalation. Cimzia® is also widely reimbursed by insurance
companies in the U.S.. In the EU, the Committee of Medicinal Products for Human Use (“CHMP”)
rejected the appeal by the Issuer against the CHMP’s refusal of marketing authorisation for Cimzia® in
the treatment of patients with Crohn’s disease in March 2008, and this indication has not been pursued
further.
Cimzia® is also now indicated for rheumatoid arthritis, having been filed with the FDA in February
2008 and in the EU in July 2008. In January 2009 the Issuer received a Complete Response Letter from
the FDA, requesting an additional safety update. In February 2009 the Issuer met with the FDA to
clarify their questions, and provided the FDA with further data. The FDA approved the application, and
the use of Cimzia® in rheumatoid arthritis was launched in the U.S. in May 2009. Since launch in the
U.S., Cimzia® sales representatives have achieved a high reach and frequency with prescribing
rheumatologists, and Cimzia® received a positive market acceptance with steadily increasing usage. A
CHMP positive opinion in Europe for the use of Cimzia® in rheumatoid arthritis was received in June
2009; as at the date of this Prospectus, EU marketing authorisation for Cimzia® is anticipated within
three months, and Cimzia® should be launched in the EU by the end of 2009. In June 2008, UCB and
Otsuka Pharmaceuticals announced a co-promotion and co-development agreement whereby the parties
will collaborate in relation to the clinical trials and filing of Cimzia® in Japan. Clinical trials for the
rheumatoid arthritis indication have commenced and first results are anticipated in 2011.
Cimzia® is marketed both by the Issuer itself and by a number of third parties which have entered into
arrangements with UCB whereby they market and distribute Cimzia® in specific geographic areas, and
receive royalties from the product sales. Such royalties in total amount to approximately 10 per cent. of
the total sales revenues relating to Cimzia®.
Product Pipeline
A number of indications are being developed for Cimzia®, including Phase III trials in psoriatic arthritis
and ankylosing spondilytis. A clinical study for juvenile rheumatoid arthritis is being planned for the
second half of 2010, and further studies of monotherapy use or use of the product in conjunction with
methotrexate are ongoing in Japan, with results expected in 2011. An induction study for Crohn’s
disease is ongoing with results due in the first part of 2010.
Epratuzumab, licensed from Immunomedics Inc., is in development for the treatment of systemic lupus
erythematosus, a chronic autoimmune disease in which the immune system attacks cells and tissues in
the body, resulting in inflammation and tissue damage. The course of the disease is highly variable and
may flare up sporadically. The cause is unknown, and November 2008 marked 50 years without a new
approved treatment for the condition. The top line results from Phase IIb testing were positive,
published in August 2009.
UCB is also developing products for the treatment of osteoporosis, a disease characterised by low bone
mass and structural deterioration of bone tissue leading to bone fragility and increased susceptibility to
fractures. Current therapies slow the deterioration but do not restore or improve the quality of bone.
Similarly, fracture healing is a widely-experienced process where the body facilitates the healing of the
bone, usually taking two to three weeks in the upper body and four weeks in the lower body, depending
on the injury. UCB intends to meet a perceived need to accelerate this process with the development of
CDP7851, for which Phase II Studies have commenced with results expected in 2012. UCB is
collaborating with Amgen Inc. on the global development of CDP7851 and the companies have
previously presented results of pre-clinical studies.
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