UCB INITIATES ADDITIONAL SHORT-TERM CLINICAL STUDY OF CIMZIA.
The initial CIMZIATM development program for the treatment of Crohn's disease met all primary endpoints with statistical significance. Therefore, whether this additional study, which was not part of the pivotal trials program initially agreed with the FDA, will be a pre-approval requirement or a post-approval commitment, is still the subject of the ongoing communications with the FDA.
UCB plans to file a Biologics License Application (BLA) with the FDA for CIMZIATM in the treatment of rheumatoid arthritis by year end 2007.
"We have complete confidence in CIMZIA(TM)'s robust efficacy and competitive safety," commented Roch Doliveux, CEO, UCB, "CIMZIATM will be, at launch, the first anti-TNF which is a PEGylated and Fc-free antibody fragment. We are looking forward to making this new treatment option available to patients who suffer from rheumatoid arthritis and Crohn's disease, and will continue our dialogue with the FDA in order to obtain approval for CIMZIATM in the US as soon as possible."
For CIMZIATM in the treatment of Crohn's disease, UCB also applied for a marketing authorization by the EMEA in April 2006 and anticipates launch in Europe at the end of 2007. In June 2005, UCB announced significant positive results for the two pivotal phase III trials (PRECiSE 1 and 2) of CIMZIATM in the induction and maintenance of clinical response in moderate to severe active Crohn's disease. The primary endpoints in both the PRECiSE 1 and PRECiSE 2 trials were met with statistical significance.
CIMZIA(TM) in the treatment of rheumatoid arthritis showed positive Phase III results demonstrating significant improvement in signs and symptoms and significant reduction in joint damage supported by strong radiographic data. Both phase III studies, RAPID 1 (027) and RAPID 2 (050), met their primary and co-primary endpoints with statistical significance.
The phase II trial (040) of CIMZIA(TM) in psoriasis has demonstrated strong efficacy in this twelve-week study in the treatment of moderate to severe chronic plaque psoriasis. A retreatment study (044) is ongoing with results expected in the third quarter of 2007.
About Crohn's disease
Crohn's disease is a chronic and debilitating inflammatory disease of the gastrointestinal tract, most commonly affecting the end of the small intestine (the ileum) and beginning of the large intestine (the colon). Together with ulcerative colitis, Crohn's disease belongs to the group of illnesses known as inflammatory bowel disease. Crohn's disease affects nearly one million people worldwide including an estimated 500,000 people in the United States. People with Crohn's disease may suffer an ongoing cycle of "flare-up" and remission. Symptoms of the disease include persistent diarrhoea, abdominal pain, and loss of appetite/weight, fever or rectal bleeding. In an effort to provide Crohn's disease patients with disease management information and resources designed expressly with their needs in mind, UCB has launched CrohnsAndMe.com - a dynamic, cutting-edge web site focused on helping patients thoroughly understand Crohn's disease and live with it every day.
About CIMZIA (certolizumab pegol)
CIMZIA (certolizumab pegol) is an investigational drug product. CIMZIA(TM) is the first and only PEGylated anti-TNF (Tumour Necrosis Factor) antibody. CIMZIATM retains the potency of the original antibody without the possible cytotoxicity mediated by the Fc portion present in conventional anti-TNFs.
CIMZIA has a high affinity for human TNF-alpha, selectively targeting TNF-alpha in inflamed tissue. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases.
Headquartered in Brussels (Belgium), UCB is a leading global biopharmaceutical company dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology - UCB focuses on securing a leading position in severe disease categories. Employing more than 8400 people in over 40 countries, UCB achieved revenue of 2.5 billion euro in 2006. UCB is listed on the Euronext Brussels Exchange and owns 87.6% of Schwarz Pharma.
For more information, visit http://www.ucb-group.com.
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|Date:||May 1, 2007|
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