UPDATE 2-UCB to pay $34.4 mln over illegal drug promotion

Thu Jun 9, 2011 1:08pm EDT

* Illegal drug promotion occurred in 2004 in U.S.

* UCB to pay $25.8 mln to settle parallel civil case (Adds plea in court, U.S. attorney, executive comments)

WASHINGTON, June 9 (Reuters) - The American unit of Belgian pharmaceutical company UCB SA (UCB.BR) pleaded guilty on Thursday and will pay $34.4 million to settle criminal and civil charges that it illegally promoted a drug for migraines.

The company pleaded guilty to one count of promoting the epilepsy treatment drug, Keppra, in the United States in 2004 for migraine treatment without the necessary approval from the Food and Drug Administration, the U.S. Department of Justice said.

The drug was only approved by the FDA to help treat those who have seizures from epilepsy.

"Today's guilty plea and UCB's $34 million payout should remind drug companies that try to cleverly design off-label marketing schemes that we will not allow them to compromise patient safety," said U.S. Attorney Ronald Machen.

The case is the latest settlement by a major pharmaceutical company over touting drugs in the United States for uses that have not been approved by the FDA, known as off-label promotion.

UCB will pay about $8.6 million in criminal fines and forfeiture and another $25.8 million to settle parallel civil allegations involving false claims submitted to U.S. federal healthcare programs, according to the plea agreement.

The company was accused of promoting Keppra with posters that claimed it was safe and effective for migraines and cited studies that it also claimed were independent -- but in fact were sponsored by UCB, according to the Justice Department.

In those posters, UCB failed to disclose that its own trials had failed to demonstrate the drug was effective for migraines or that it had backed the studies, the agency said.

As part of the settlement, the company agreed to implement procedures and reviews to avoid and detect any future similar conduct. As a result, UCB will not face probation, according to the plea agreement filed in court.

The head of the company's North American operations said in a statement that UCB has worked to improve its compliance program and takes the matter "very seriously."

"We are pleased to have resolved this matter and look forward to continuing to work with the many organizations with whom we partner to advance our mission of transforming the lives of people living with severe diseases," said Greg Duncan, UCB's president for North American Operations.

The case is USA v. UCB Inc., No. 11-mj-375 in U.S. District Court for the District of Columbia. (Reporting by Jeremy Pelofsky with additional reporting by Lisa Richwine, editing by Lisa Von Ahn and Gerald E. McCormick)

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