Cosmo Pharmaceutical SpA (COPN), the Italian developer of treatments for digestive-tract infections, fell the most in almost three years in Zurich after Dutch regulators declined to approve its drug for inflammatory bowel disease.
Holland’s Medicine Evaluation Board rejected approval for the product, known as Cortiment, on grounds of “clinical relevance” and will send a formal letter detailing the reasons for the denial, Lainate, Italy-based Cosmo said in a statement. The drugmaker may appeal the decision, according to Chief Executive Officer Mauro Ajani.
“We believe that Cortiment is a clinically effective option for patients with mild to moderate ulcerative colitis,” Ajani said in the statement. “We are therefore assessing means to have MEB review its decision.”
As the European Union reference agency for Cortiment, the MEB’s decision is likely to slow the introduction of the drug in certain members of the bloc. The ruling shouldn’t influence the result of a review of Cortiment by the U.S. Food and Drug Administration, which is due to make a decision on the product by Oct. 19, Peter Welford, an analyst at Jefferies International Ltd., said in a note today. Jefferies maintains a buy recommendation on the stock.
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