UCB has been stunned by the news this morning that advisors to Europe’s health regulator have not recommended approval of the Belgian firm’s Cimzia for Crohn’s disease.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the firm’s market authorisation application for Cimzia (certolizumab pegol) in the treatment of patients with Crohn's disease. UCB immediately announced its intention to appeal the decision which represents a major setback to the firm as Cimzia has been touted as a blockbuster.

The EMEA was still putting the finishing touches to its explanation as to why the CHMP is not looking favourably on Cimzia when contacted this morning but Antje Witte, a spokeswoman at UCB, shed some light on the situation. She told PharmaTimes World News that the efficacy and tolerability of Cimzia is not the issue but it is more a problem of the way the data was presented. The CHMP expressed concern not about the quality of the drug but rather the means in which the production steps have been documented in the filing which was based on the PRECiSE studies involving over 1,500 patients.

The CHMP also mentioned problems of bleeding, but that it is a symptom of having Crohn’s disease, an inflammatory disease of the gastrointestinal tract, and is not an issue linked solely to Cimzia per se. “There is nothing wrong with the product, “ Ms Witte told PharmaTimes World News but one of the problems with getting the green light in Europe is that there is no such thing as an approvable letter as in the USA. “There is only black or white,” she added.

UCB has 15 days to file its appeal and the time required by the EMEA and CHMP to review the case means that a decision is expected during the first half of 2008. By that time, Cimzia, which was approved in Switzerland in September, will have lost even more ground on Abbott Laboratories' rival drug Humira (adalimumab), which was launched in Europe as a treatment for Crohn’s in the summer. Cimzia has also had its problems in the USA after the Food and Drug Administration asked for additional information on the drug in March.

Ms Witte also noted that UCB is sorting out a separate submission for Cimzia in the treatment of rheumatoid arthritis in the USA which should be filed by the end of 2007 and she noted that the firm has every confidence in the drug. This morning, however, that confidence is not shared by the investment community and the shares were down 13.5% to 31.95 euros at 9.50am.

The importance of the drug to UCB’s future growth is considerable, especially as it will lose patent protection on its biggest earners – the allergy drug Zyrtec (cetirizine) and the antiepileptic Keppra (levetiracetam) – in 2007 and 2009 respectively. By Kevin Grogan