New Data Suggest CIMZIA(R) (Certolizumab Pegol) Active in Treating Moderate to Severe Crohn's Patients With Fistulizi...(. For the placebo group AEs included hea...)

Date:12/5/2008

. For the placebo group AEs included headache (7%), nasopharyngitis (4%) and cough (<1%). The incidence of injection site pain was lower in the CIMZIA(R) group (<1%) compared to in the placebo group (5%). Serious AEs were broadly similar in both groups (6% CIMZIA(R) versus 7% placebo). Three percent and less than 1% respectively were due to infection or infestation; 2% and 4% respectively were due to gastrointestinal disorder.

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(R) for up to six months, compared to placebo. The safety and tolerability of CIMZIA(R) 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(R) 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 >70 or absolute CDAI of >350) were re-introduced to CIMZIA(R) 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, progressive, destructive disorder that causes inflammation of the gastrointestinal (GI) tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon). If not effectively treated, it may results in the need for surgery and hospitalization. Crohn's disease has been estimated to affect as many as half a million Americans. People with Crohn's c
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