* FAST 4WARD showed monotherapy Cimzia® 400 mg, dosed every four weeks, provided significant and effective clinical benefits compared to placebo* RAPID 2 trial showed Cimzia®, together with methotrexate (MTX), achieved significant reduction in signs, symptoms and progression of rheumatoid arthritis

Brussels, Belgium, November 18, 2008 at 7:00 AM (CET) - UCB todayannounced the results of two phase III studies, published in theAnnals of the Rheumatic Diseases Online, showing Cimzia®(certolizumab pegol), the only PEGylated anti-TNFalpha (TumourNecrosis Factor alpha), provided significant clinical benefits asmonotherapy, and in combination with methotrexate, in adults withactive rheumatoid arthritis (RA).

The six month FAST 4WARD study met primary and secondary endpoints*,and showed 400 mg certolizumab pegol, given every four weeks assubcutaneous monotherapy, significantly reduced signs, symptoms andpain associated with RA, and improved physical function, compared topatients treated with placebo (p < 0.001).

"The positive outcomes of the FAST 4WARD study are exciting anddemonstrate the potential for certolizumab pegol as a future therapydosed every four weeks for patients with rheumatoid arthritis. Whilethe RAPID studies have shown the benefits of certolizumab pegol ascombination therapy, this is the first phase III trial to show aclinical benefit as monotherapy which becomes important when patientsmust discontinue treatment due to tolerability issues withconventional treatments, or have contraindications." said ProfessorRoy Fleischmann, University of Texas Southwestern Medical Centre,Dallas.

Meeting the primary endpoint*, patients treated with certolizumabpegol demonstrated significantly superior ACR20 response rates atWeek 24 versus those on placebo (p < 0.001: 45.5% versus 9.3%). Theresponse to treatment was rapid and significant with more than onethird (36.7%) of patients on certolizumab pegol achieving an ACR20response as early as Week 1 of treatment, compared to less than 10per cent on placebo (p < 0.05), which was sustained throughout thestudy.

Patients on certolizumab pegol also reported clinically significantimprovements in physical function (HAQ-DI) from Week 1 through toweek 24, relative to placebo (p < 0.001), consistent with significantlyreduced pain scores (VAS) and disease activity (DAS28-3) (p < 0.001).

In the study, serious adverse events (SAEs) occurred 2.8% and 7.2% ofpatients in the placebo and the certolizumab pegol groups,respectively. Reported SAEs included infections and benigntumours. The majority of AEs reported in both treatment groups weremild to moderate. The most commonly occurring AEs were headache,nasopharyngitis, and upper respiratory tract infections, diarrhea andsinusitis. The incidence of injection site pain (1.8%) anddiscontinuations due to AEs (4.5%) were low in the certolizumab pegolgroup.

A second six month study called RAPID 2**, published this week,showed treatment with certolizumab pegol, together with methotrexate(MTX), significantly improved the clinical signs and symptoms of RA,inhibited progression of disease, and improved physical function inadult patients with active disease.

"The RAPID 2 study is important in demonstrating the benefits ofcertolizumab pegol in reducing the pain and symptoms of rheumatoidarthritis, and in helping to prevent joint damage associated withthis debilitating condition in patients with active disease," saidlead author Professor Josef Smolen, Division of Rheumatology, MedicalUniversity of Vienna.

"These findings expand data from RAPID 1 and its extension studypresented at the 2008 American College of Annual Scientific Meetingwhich showed the long-term benefits of certolizumab pegol inproviding relief of symptoms, improving productivity and quality oflife and lessening fatigue," said Professor Smolen.

In the RAPID 2 study, patients were randomly allocated to receive oneof three treatment regimens: certolizumab pegol 400 mg at Weeks 0, 2and 4, then 200 mg every two weeks; certolizumab pegol 400 mg every 2weeks; or placebo every 2 weeks, together with MTX.

In RAPID 2, patients treated with Cimzia® (200 mg or 400 mg),together with MTX, showed significantly superior ACR20 responses asearly as Week 1, compared to patients treated with placebo and MTX(p < 0.01), which were sustained throughout the study (p < 0.001).

Patients in both certolizumab pegol treatment arms reportedclinically significant improvements in physical function (HAQ-DI)from week 1, compared to placebo versus MTX, with improvements inquality of life sustained up to Week 24 (p < 0.001). In addition,certolizumab pegol, inhibited progression of structural joint damage,with significantly smaller mean change from baseline in modifiedTotal Sharp Score (TSS) at week 24, compared to MTX alone (p < 0.001).

There were no statistically significant differences in clinicalefficacy on primary or secondary end points between the 200 mg and400 mg certolizumab pegol treatment arms.

The simultaneous studies, RAPID 2 and RAPID 1***, are the firstlarge, placebo-controlled Phase III trials demonstrating the efficacyand tolerability of certolizumab pegol in the treatment of RA, aspart of clinical trials programme involving more than 2,300 patients.

The most commonly reported SAEs were infections (includingtuberculosis) and malignancies (including lymphoma). The mostcommonly reported AEs were headache, nasopharyngitis, and upperrespiratory tract infections. Pooled safety data from both studiesshowed that the incidence of injection site pain (n = < 3 new cases /100patient years) and discontinuations due to adverse events (AEs) werelow in the certolizumab pegol group.

The U.S. Food and Drug Administration (FDA) accepted a BiologicsLicense Application for Cimzia® for the treatment of adult patientswith active RA in February 2008. UCB submitted a MarketingAuthorisation Application to the European Medicines Agency in June2008 requesting the approval of Cimzia® as a subcutaneous treatmentfor adults with moderate to severe active RA.

*About FAST 4WARD (Study 011)

The 24-week FAST 4WARD (eFficAcy and Safety of cerTolizumab pegol - 4Weekly dosAge in RheumatoiD arthritis, Study O11) was designed toevaluate the efficacy and tolerability of certolizumab pegol 400 mgas monotherapy. The phase III randomised, double-blind,placebo-controlled trial involved 220 adult patients with active RAwho had previously failed at least one disease-modifyinganti-rheumatic drug (DMARD). Patients were randomised to receiveeither 400 mg certolizumab pegol subcutaneously every four weeks(n=111), or placebo - sorbitol (n=109). Patients were assessed forimprovement in signs and symptoms of RA. FAST 4WARD met its primaryendpoint ACR20 response rate at Week 24, and secondary endpointsincluding ACR50 and ACR70 responder rates. Patients who receivedcertolizumab pegol experienced clinically and statisticallysignificant improvements in all ACR components at Week 24 compared tothose on placebo (p < .05).

**About RAPID 2

This Phase III double-blind placebo-controlled trial, involving 619patients with active adult-onset RA was designed to evaluate theefficacy and tolerability of subcutaneous (SC) liquid certolizumabpegol (200 and 400 mg) together with MTX every 2 weeks compared toplacebo together with MTX in patients with active RA despite >= 6months treatment with MTX. Patients were randomly allocated toreceive one of three treatment regimens: 246 patients receivedcertolizumab pegol (liquid formulation) 400 mg and at Weeks 0, 2 and4, then 200 mg every two weeks; 246 patients received certolizumabpegol (liquid formulation) 400 mg every 2 weeks; 127 patientsreceived placebo every 2 weeks. RAPID 2 met its primary endpointACR20 response rate at Week 24, and secondary endpoints: change frombaseline in mTSS, ACR 50 and ACR 70 responses at Week 24.Significantly more patients in the certolizumab pegol 200 and 400 mggroups achieved an ACR20 response versus placebo (p < = 0.001); rateswere 57.3%, 57.6%, and 8.7%, respectively. Certolizumab pegol 200 and400 mg also significantly inhibited radiographic progression; meanchanges from baseline in mTSS at Week 24 were 0.2 and -0.4,respectively, versus 1.2 for placebo (rank analysis p < = 0.01).Certolizumab pegol treated patients reported rapid and significantimprovements in physical function versus placebo (p < = 0.001).

***About RAPID 1

The Phase III double-blind placebo-controlled trial, involving 982adults, was designed to establish the efficacy and tolerability ofcertolizumab pegol together with MTX, in the treatment of active RAin patients who did not adequately respond to conventional treatment.Patients were randomly allocated to receive one of three treatmentregimens: 393 patients received certolizumab pegol 400 mg and atWeeks 0, 2 and 4, then 200 mg every two weeks; 390 patients receivedcertolizumab pegol 400 mg every 2 weeks; 199 patients receivedplacebo every 2 weeks. RAPID 1 met co-primary endpoints: ACR20response rate at Week 24 and change from baseline in mTSS at Week 52.

About CIMZIA®

Cimzia® is the only PEGylated anti-TNF (Tumour Necrosis Factor).Cimzia® has a high affinity for human TNF-alpha, selectivelyneutralising the pathophysiological effects of TNF-alpha. Over thepast decade, TNF-alpha has emerged as a major target of basicresearch and clinical investigation. This cytokine plays a key rolein mediating pathological inflammation, and excess TNF-alphaproduction has been directly implicated in a wide variety ofdiseases. The U.S. Food and Drug Administration (FDA) has approvedCimzia® for reducing signs and symptoms of Crohn's disease andmaintaining clinical response in adult patients with moderate tosevere active disease who have had an inadequate response toconventional therapy. Cimzia® was approved in Switzerland forinduction of a clinical response and for the maintenance of aclinical response and remission in patients with active Crohn'sdisease who have not responded adequately to conventional treatmentin September 2007. UCB is also developing Cimzia® in rheumatoidarthritis and other autoimmune disease indications. Cimzia ® is aregistered trademark of UCB S.A.

For further informationScott Fleming, Global Communications Manager - InflammationT +44.770.277.7378, Scott.fleming@ucb-group.comMichael Tuck-Sherman, Investor Relations, UCB GroupT +32.2.559.9712, Michael.Tuck-Sherman@ucb-group.com

About UCB

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

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