In its most recent round of product reviews, a European Union committee denied marketing applications for two different drugs whose ability to reach the market in the EU could have ramifications in the U.S.

The European Medicines Agency's Committee for Medicinal Products for Human Use maintained its negative recommendation for Pharming's experimental hereditary angioedema therapy Rhucin (recombinant human C1 inhibitor) and rejected an appeal by UCB on its application to market Cimzia (certolizumab pegol) for Crohn's disease.

Pharming, in Leiden, Netherlands, said it intends to file in the EU again, this time with additional data from a recently completed North American Phase III trial that may satisfy CHMP's concerns regarding Rhucin's safety.

Data from that study, which will become available in the second quarter, also will be used by Pharming to support a BLA submission.

CHMP first rejected Pharming's Rhucin application in December, citing concerns about patients developing antibodies following repeated doses of the recombinant therapy.

Pharming trails its competition in the race to gain approval for the first HEA therapy in the U.S. New York-based Lev recently released data on its C1 inhibitor Cinryze , which may turn out to be the only product approved with a prophylactic indication (¹ Also see "Lev Shows Cinryze Prophylactic Data" - Pink Sheet, 19 March, 2008.).

Other candidates include Bern, Switzerland-based CSL Behring's C1-INH, marketed in Europe as Berinert . CSL submitted the C1-INH BLA March 6 (² Also see "CSL Behring Submits C1-INH For Hereditary Angioedema" - Pink Sheet, 6 March, 2008.).

The EU setback is not the only one UCB has had for Cimzia. The Brussels, Belgium, firm received a "complete response" letter from FDA in December 2006 for the PEGylated Fab fragment TNF inhibitor in the Crohn's indication (³ Also see "UCB Receives “Complete Response” Letter For Cimzia" - Pink Sheet, 22 December, 2006.).

UCB has launched a new study, slated to produce results during the second half of this year, to satisfy the agency's concerns over a lack of induction evaluation criteria in one of the two pivotal trials it used to support the BLA.

CHMP noted in its second denial of the Crohn's application that UCB has satisfied some of the concerns it expressed in a November 2007 negative opinion. Nonetheless, the committee said it maintains a general concern about Cimzia's safety.

In a statement, UCB Senior VP-Olav Hellebo said that while CHMP's negative opinion was a disappointing one for the firm UCB was "pleased that specific safety and quality concerns raised by the committee in November were resolved through the appeals process."

In February, UCB submitted a BLA seeking approval of Cimzia in the treatment of rheumatoid arthritis (⁴ Also see "UCB Seeks FDA Approval For Cimzia In Rheumatoid Arthritis" - Pink Sheet, 6 February, 2008.).

-Shirley Haley (s.haley@elsevier.com)

EU Committee Upholds Negative Opinions On Cimzia, Rhucin Applications

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