January 26, 2010 / 4:02 PM / 10 years ago

Novartis will plead guilty to US Trileptal charges

* To pay $185 mln fine over epilepsy drug

* Cooperating with investigation into other drugs

(Adds more details on charges and provisions)

BASEL, Switzerland, Jan 26 (Reuters) - Novartis NOVN.VX will plead guilty to violating U.S. laws relating to potential off-label marketing and promotion of an epilepsy treatment and pay a $185 million fine, it said on Tuesday.

The Swiss drugmaker said its pharmaceuticals unit had been cooperating with parallel civil and criminal investigations by the U.S. Attorney’s Office for the Eastern District of Pennsylvania (EDPA) into Trileptal marketing and promotion.

The EDPA was also investigating certain payments made to healthcare providers in connection with Trileptal.

“In the fourth quarter of 2009, Novartis increased provisions relating to the EDPA’s Trileptal investigations by $318 million,” it said in a statement, in which it also appointed a new chief executive and higher fourth-quarter profit. [ID:nLDE60P0RD]

Novartis Pharmaceuticals is also cooperating with an EDPA investigation into potential off-label marketing and promotion as well as payments made to healthcare providers in connection with five other products: Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

“Novartis is unable to assess with reasonable certainty the outcome of the investigation related to these five products or the amounts, which could be material, that it might be required to pay to resolve this investigation,” the company said. (Reporting by Sam Cage, editing by Will Waterman)

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