Elan and Eisai are served
The Office of the Inspector General has served Elan and Eisai subpoenas requesting documents and materials relating to their marketing practices for the anti-epilepsy agent Zonegran (zonisamide). The Department of Justice also subpoenaed Elan seeking similar information. Eisai acquired Zonegran from Elan in 2004 ("1The Pink Sheet" April 5, 2004, In Brief). Both companies say they will cooperate with the investigation...
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Litigation In Brief: Elan, Novartis Resolve Federal Marketing Investigations
Elan to settle DoJ Zonegran investigation: Elan announced on July 15 that it has reached an agreement in principle with the U.S. Attorney's Office in Massachusetts to pay $203.5 million to settle an investigation of its sales and marketing practices for the antiepileptic Zonegran (zonisamide). The company said it expects to plead guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act and to enter into a corporate integrity agreement with the HHS Office of Inspector General. Eisai acquired Zonegran from Elan in 2004. In 2006, the OIG served Eisai and Elan with subpoenas requesting their marketing materials for the drug (1"The Pink Sheet," Feb. 6, 2006)
Eisai acquires Elan’s Zonegran
Eisai acquires Elan anti-epilepsy agent Zonegran (zonisamide) for $130 mil., plus up to $110 mil. in milestone payments. Eisai also will hire 100 of Elan's sales reps to market the product. Acquisition is part of Eisai's strategy to grow its neurological franchise and its presence in the U.S. Elan's divestiture is one of several used to raise cash ahead of key launches, including Antegren for multiple sclerosis and Crohn's disease in 2005 (1"The Pink Sheet" Feb. 23, 2004, p. 25)...
Stage Set For Generics To Triumph With Skinny-Label Reversal
With the US solicitor general offering support for Teva over GSK in long-running litigation over skinny-label carve-outs of generic indications, the stage could be set for a major reversal at the Supreme Court that would favor the generics industry.