Healthcare Industry News: S.A.
News Release - November 16, 2007
UCB to Appeal European Negative Opinion on CIMZIA(R) for the Treatment of Patients with Crohn's Disease
BRUSSELS, BELGIUM--(Healthcare Sales & Marketing Network)--Nov 16, 2007 -- Brussels (BELGIUM), November 16, 2007 at 7:00 am CET - UCB announced today that it has been informed by the European MedicineS.A.ency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) haS.A.opted a negative opinion on the market authorisation application (MAA) in the EU for CIMZIA® certolizumab pegol) in the treatment of patients with Crohn's diS.A.e.UCB plans to utilise the appeal process to request a CHMP re-examination of the submission. A decision is expected during the first half of 2008.
"UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of CIMZIA®. UCB will continue to work with the CHMP to address the Committee's concerns to obtain its endorsement to allow this treatment option to be available to people suffering from Crohn's diS.A.e." said Melanie Lee, Executive Vice President ReS.A.ch & Development of UCB.
About CIMZIA®
CIMZIA® is the only PEGylated anti-TNF (Tumour Necrosis Factor). CIMZIA® haS.A.high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged aS.A.major target of basic reS.A.ch 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 diS.A.es.
UCB filed a Biologics License Application (BLA) with the Food and Drug Administration (FDA) for CIMZIA® in the treatment of Crohn's diS.A.e on February 28, 2006. CIMZIA® waS.A.proved in Switzerland for the treatment of Crohn's diS.A.e in September 2007. Preparation for a regulatory submission for CIMZIA® in the treatment of rheumatoid arthritis in the U.S. is ongoing.
The MAA was based on the pivotal PRECiSE studies involving over 1,500 patients with Crohn's diS.A.e.[1],[2]
Further information
Antje Witte, Vice-President Corporate Communications & Investor Relations, UCB Group
T +32.2.559.9414, Antje.witte@ucb-group.com
Mareike Mohr, Associate Director Investor Relations, UCB Group
T +32.2.559.9264, Mareike.mohr@ucb-group.com
References
1. Sandborn WJ et al. Certolizumab pegol for the treatment of Crohn's diS.A.e. NEJM 2007;357:228-38.
2. Schreiber S et al. Maintenance therapy with certolizumab pegol for Crohn's diS.A.e. NEJM 2007;357:239-50.
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) iS.A.global leader in the biopharmaceutical industry dedicated to the reS.A.ch, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diS.A.es, immune and inflammatory disorderS.A.d oncology. UCB focuses on securing a leading position in severe diS.A.e categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchange and, through itS.A.filiate, ownS.A.prox. 89% of the S.A.es of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany).
Forward looking S.A.ement
This press release contains forward-looking S.A.ements based on current plans, estimateS.A.d beliefs of management. Such S.A.ementS.A.e subject to riskS.A.d uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking S.A.ements contained in this press release. Important factors that could result in such differences include: changes in general economic, businesS.A.d competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuationS.A.d hiring and retention of its employees.
Source: UCB
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