The Dutch Regulatory Agency has declined Cosmo Pharmaceutical’s Cortiment drug for the treatment of ulcerative colitis.

The decision was based on "grounds of clinical relevance", but Cosmo is awaiting a formal letter from the agency which will explain the reasons in more detail, the Swiss drug maker said in a statement.

Cosmo CEO and chairman Mauro Ajani said, "We believe that Cortiment MMX is a clinically effective option for patients with mild to moderate ulcerative colitis and we are supported in this belief by the major key opinion leaders. We are therefore assessing means to have MEB review its decision".

The rejection caused Cosmo shares to fall by 12%, the biggest decline since September 2009, pushing the company’s stock to 22.65 francs, reports Bloomberg.

But approval for Cortiment hasn’t been ruled out, as it will be reviewed by the US Food and Drug Administration in October 2012.

Ulcerative Colitis is a form of inflammatory bowel disease for which there is no known cure, but with appropriate treatment patients can manage their symptoms.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData

It is estimated that 800,000 people in the US and 900,000 people in the EU suffer from the illness.