UCB Pharma Canada

BURLINGTON, ONTARIO--(Marketwire - Oct. 8, 2008) - UCB Pharma Canada today announced data presented at the American College of Gastroenterology (ACG) Scientific Meeting, in Orlando, Florida, from two studies demonstrating that CIMZIA^® (certolizumab pegol) - the only PEGylated anti-TNF (Tumor Necrosis Factor alpha) - provides sustained improvement in symptoms with stable dosing for adult patients suffering from moderate-to-severe Crohn's disease (CD). A third study presented by UCB provided a comparison of treatment costs and found that CIMZIA offers a cost savings versus other commonly-used biologics.

An analysis of the PRECiSE 3 open-label extension study data showed that after 2.5 years (30 months) of treatment with CIMZIA, 72 per cent of patients were in remission based upon responder analysis. These clinical trial data will be presented by William Sandborn, M.D., of the Mayo Clinic in Rochester, Minn., a study investigator. Previously, UCB had reported remission data up to 18 months.

Furthermore, data from the WELCOME study showed that 39 per cent of patients who responded to CIMZIA treatment after failing infliximab therapy achieved clinical remission within six weeks. Additionally, there were no differences in clinical response rates regardless of the reason for infliximab failure, and irrespective of treatment as a monotherapy or in combination with other common Crohn's disease medications.

Certolizumab pegol is currently not approved for any indication in Canada.

WELCOME Study (Abstract #P283)

Data from the Phase IIIb WELCOME study showed that 39 per cent of patients who responded to CIMZIA treatment after failing infliximab therapy achieved clinical remission at Week 6 as measured by the Crohn's Disease Activity Index (CDAI). In addition, the study found that 61 per cent of study patients reduced CDAI symptom scores by 100 points and 68 per cent reduced CDAI scores by 70 points. The CDAI is a patient/physician questionnaire which incorporates eight CD-related variables. Scores of less than 150 indicate remission, and scores of greater than 450 indicate severe illness along the 600 point scale.

Response to CIMZIA was similar when used as a monotherapy or with concomitant corticosteroids or immunosuppressants. There were also no differences in clinical responses to CIMZIA among those patients who had previously lost response to infliximab (62 per cent), were hypersensitive to infliximab (61 per cent) or both (58 per cent).

PRECiSE 3 Study (Abstract #P280)

The PRECiSE 3 (P3) open-label extension study of PRECiSE 1 and PRECiSE 2 was designed to evaluate the longer-term safety and effectiveness of CIMZIA in patients completing the other two studies. The 30-month analysis includes data from 141 patients who have been continuously treated with CIMZIA for 2.5 years. At the beginning of P3, 73 per cent of CIMZIA-treated patients were in remission. After 2.5 years (30 months) of treatment with CIMZIA, 72 per cent of patients were in remission based upon responder analysis. The incidence of injection site pain was low in the CIMZIA group, and no new safety signals observed over 30 months (2.5 years) of active treatment.

Pharmacoeconomics Study (Abstract #P277)

A comparative estimate of treatment costs showed that CIMZIA provided more cost savings during induction and maintenance phases of treatment when compared to infliximab and adalimumab. A cohort budget analysis estimate performed for a healthcare plan of 5 million members -- with a CD prevalence of 162 per 100,000 and incidence rate of 9.6 per 100,000 -- showed that access to CIMZIA provided a savings of more than $1.5 million compared to a healthcare plan that did not include CIMZIA.

About WELCOME

The WELCOME study is a 539 patient Phase IIIb multicenter 26-Week trial Evaluating the clinical benefit and tolerability of certoLizumab pegol induCtiOn and Maintenance in patients suffering from Crohn's disease with prior loss of response or intolErance to infliximab. It consists of an open-label induction phase (400 mg of CIMZIA sub-cutaneously at Weeks 0, 2 and 4) and a double-blind maintenance period (400 mg of CIMZIA every 2 or 4 weeks from Week 6). The primary endpoint was defined as the rate of response (defined as a decrease in CDAI score =100 points from baseline) at Week 6. Remission was defined as a CDAI score of =150 points. After the induction period, 62 per cent of patients achieved response and 39 per cent achieved remission. One-third of patients had responded to treatment by Week 2 (33 per cent) and more than forty per cent (44 per cent) had responded by Week 4.

About the PRECiSE Clinical Trial Program

PRECiSE, one of the largest, most comprehensive development programs for an anti-TNF for Crohn's disease is composed of two placebo-controlled studies and two open-label safety follow-up studies. In 2007, the two former studies were published in the New England Journal of Medicine (NEJM). The studies demonstrated that patients with moderate to severe Crohn's disease achieved and sustained clinical response with CIMZIA for up to six months, compared to placebo. The safety and tolerability of CIMZIA was consistent with that expected of an anti-TNF agent. In the first follow-up study, patients completing both initial studies are to be given CIMZIA every four weeks for up to seven years. In the second follow-up study, patients who relapsed in either initial study (defined as an increase in CDAI of greater than 70 or absolute CDAI of greater than 350) were re-introduced to CIMZIA every four weeks to be continued for up to seven years, with a single additional dose at week 2.

About Crohn's Disease

Crohn's disease is a chronic and debilitating inflammatory disease of the gastrointestinal tract, affecting more than 170,000 people in Canada. The onset of Crohn's disease often occurs between the ages of 18 and 25. As Crohn's disease is a chronic ailment, people go through unpredictable periods in which the disease flares and causes symptoms. These episodes are followed by times of remission - periods in which symptoms disappear or decrease and good health returns. Canada has one of the highest incidence and prevalence of Crohn's disease in the world.

About UCB

UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing around 12 000 people in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB is listed on Euronext Brussels (symbol: UCB).

About UCB Pharma Canada Inc.

UCB Pharma Canada Inc. was officially incorporated in 2006 with the objective of bringing a new-generation, convenient therapy to the Canadian market for auto-immune, inflammatory diseases. As a patient-focused organization, UCB Pharma Canada is dedicated to bringing new and innovative programs to patients, and to the specialists who treat them, to help improve the lives of people living with severe diseases.

Forward-Looking Statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.