|Biovail will continue to market its hypertension drug. Source: AccuMed of South Louisiana|
Biovail Pharmaceuticals has reached an agreement with the U.S. Department of Justice (DoJ) with respect to criminal allegations related to activities surrounding the 2003 commercial launch of Cardizem LA, indicated to treat hypertension and for the management of chronic stable angina.
Under the terms of the agreement, Biovail said it would plead guilty to charges relating to making payments to induce purchasing or ordering of Cardizem LA in 2003 and would pay $24.6 million to fully settle the matter. As part of the agreement, Biovail said it expects to receive full releases for all matters related to the DoJ’s investigation.
In particular, Biovail said the allegations relate to prior management’s actions in 2002 and 2003 regarding the Cardizem LA clinical program, PLACE (Proving L.A. through Clinical Experience).
The agreement eliminates any criminal liability for Biovail arising from the matter, and preserves the company’s ability to conduct business in the U.S., according to the Toronto-based company.
Without the agreement, Biovail said it was at risk of being excluded from doing business with any health program sponsored by the U.S. federal government, which represent a material proportion of its business.
The agreement is subject to approval at a court hearing that is expected to take place between July 31 and Sept. 15, according to the company.
“We are pleased to resolve another legacy action. The agreement with the DoJ represents the fourth such action to be resolved in the past six months,” said Bill Wells, Biovail’s CEO. “This is an important and positive result for Biovail and its shareholders as the agreement eliminates the significant exposure to the corporation related to this matter and should immediately reduce our ongoing legal expenses.
“As we continue to work to resolve the regulatory and legal matters that remain outstanding, our primary focus is on implementing our new strategic focus – one we believe will enhance value for all shareholders,” Wells said.
Biovail said the agreement will not affect the current or future its medicines approved for use in the U.S., and will not affect its continued marketing of Cardizem LA.