FDA Agrees to Review Cimzia File for the Treatment of Rheumatoid Arthritis

February 11, 2008

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February 06, 2008 -- UCB today announced that the U.S. Food and Drug

Administration (FDA) agreed to accept, for filing and review, a biologics

license application (BLA) for Cimzia® (certolizumab pegol) for the

treatment of adult patients with active rheumatoid arthritis (RA). Cimzia®

is an investigational agent.

If approved, Cimzia® will be the first and only PEGylated anti-TNF (Tumor

Necrosis Factor) biologic therapy available for the treatment of rheumatoid

arthritis.

" As a new anti-TNF, we believe that Cimzia® would provide an important new

option for people living with this disease, " said Olav Hellebo, President

Inflammation Operations, UCB.

The BLA is based on data from more than 2,367 patients and includes three

multi-center, placebo-controlled Phase III trials which were recently

presented at the of Rheumatology (ACR) Annual Scientific Meeting.

In these studies, Cimzia®, given with methotrexate, was shown to be

significantly more effective than methotrexate alone for the inhibition of

joint damage progression in patients with active RA as early as 24 weeks

(RAPID 1 and RAPID 2). Cimzia® was shown to rapidly reduce the signs and

symptoms of active RA with peak ACR50 and 70 responses achieved at 14 and 16

weeks.

Improvement in physical function and quality of life measures were also seen

for up to one year (RAPID 1).

Further, Cimzia® administered as monotherapy showed significant

improvement in signs and symptoms of RA from week 1, and this benefit was

maintained through week 24 (Study 011).

The most commonly occurring adverse reactions were headache,

nasopharyngitis, and upper respiratory tract infections. Reported serious

adverse reactions were infections (including tuberculosis) and malignancies

(including lymphoma), consistent with findings from other trials in the

anti-TNF class.

Preparation for submission of a Marketing Authorization Application (MAA) to

the European Medicines Agency (EMEA) for Cimzia® in the treatment of RA is

ongoing, with filing planned in the first half of 2008.

In September 2007, Cimzia® was approved in Switzerland for the treatment

of Crohn's disease and it was launched in January 2008.

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