ATLANTA, June 9, 2011 /PRNewswire/ -- UCB, Inc. today announced an agreement with the U.S. Department of Justice (DOJ) to resolve a previously disclosed government investigation into the marketing and promotion of Keppra®, an anti-epileptic prescription medicine. As previously reported, the issues that were the subject of this investigation occurred more than six years ago, and as recognized by the DOJ, UCB has cooperated fully with the United States since learning of the investigation in 2008.
Under the agreement, UCB pled guilty to a single misdemeanor violation and agreed to pay USD 8.6 million under the Federal Food, Drug and Cosmetic Act. UCB also entered into a separate civil settlement agreement and will pay USD 25.8 million plus modest interest to the United States and State Medicaid programs to resolve allegations relating to the False Claims Act. As with many other pharmaceutical settlements, UCB also agreed to enter into a five-year corporate integrity agreement (CIA) with the Office of Inspector General of the U.S. Department of Health and Human Services.
This CIA builds upon and requires the maintenance of UCB's existing compliance program. The commitments in the CIA are also consistent with UCB's previously stated commitment to comply with the laws and regulations that govern the pharmaceutical industry as evidenced last year by the company's voluntary public certification to adhere to PhRMA's Code on Interactions with Healthcare Professionals.
"UCB takes compliance with all applicable laws, policies, and procedures very seriously and remains committed to the highest standards of corporate conduct," said Greg Duncan, UCB's President for North American Operations. "We have worked diligently over the years to enhance our compliance program and we continue to evolve our compliance efforts to meet the changing demands of the regulatory environment in which we operate. 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."
About UCB, Inc.
UCB Inc., is a Delaware corporation. Its parent company, UCB S.A., is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 8,500 people in more than 40 countries, UCB generated revenue of EUR 3.2 billion in 2010. UCB is listed on Euronext Brussels (symbol: UCB).
Forward looking statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
For further information
Kristie Madara, U.S. Corporate Communications
(770) 970-8726, [email protected]
Nancy Nackaerts, Global External Communications
+32 473 86 44 14, [email protected]
Antje Witte, Investor Relations
+32 2 559 94 14, [email protected]
SOURCE UCB, Inc.