FDA Seeks More Data On Lundbeck’s Serdolect Drug

Danish pharmaceutical firm H. Lundbeck A/S (LUN.KO) said late Thursday the US Food and Drug Administration (FDA) has requested more data on its Serdolect treatment for schizphrenia.

“In the coming months Lundbeck is committed to addressing the FDA’s Complete Response Letter (CRL) and will work with the agency to expedite completion of its review”, the Copenhagen-based company said.

The CRL requests further data to help understand which patients might benefit from the drug.

This could be costly for the company and force a re-think on the worthiness of entering the U.S., says Jyske Bank’s Lars Terp Paulsen.

“It’s already approved in Europe so if new U.S. testing becomes too expensive, they’ll have to evaluate the benefits of drug approval for the U.S. market,” he said.

Lundbeck shares slid on the news and at 0735 GMT they traded down 1.9% at DKK101.25, underperforming a broadly higher Copenhagen market. The stock has lost more than 15% of its value in the last 12 months, weighed by a profit warning and concerns over drug approvals.

Lundbeck had expected FDA approval of the drug six weeks ago, following an advisory panel recommendation in April.

However, the panel said at the time that use of the drug should be limited to a small group of patients due to risks of cardiac arrest.

Additionally, the Psychopharmacology Drug Advisory Committee (PDAC), appointed by the FDA, voted in early April that Serdolect is efficacious in the treatment of schizophrenia, but that data didn’t support an additional claim related to treatment of suicidal behaviour.

A majority of the committee voted against its use in a broad schizophrenia population due to safety concerns.

North America is widely expected to become a main growth driver for Serdolect. In 2008, global sales of the drug, which is sold in some 40 countries, reached only 58 million Danish kroner ($10.9 million) or 0.5% of total group sales.

Lundbeck said that “the content of this release will have no influence on the Lundbeck Group’s financial result for 2009”.

Company Web site: http://www.lundbeck.com

-By Dominic Chopping; Dow Jones Newswires; +46 (0) 8 545 130 93, .(JavaScript must be enabled to view this email address) (Ian Edmondson contributed to this story.)