Abbott settled a massive federal and state lawsuit over off-label marketing of Depakote to the tune of $1.5 billion and a token guilty plea – on one violation of the FD&C Act, for misbranding – along with a five-year Corporate Integrity Agreement. The settlement with 49 states, the District of Columbia and the federal government, includes a criminal fine and forfeiture of $700 million, civil settlements of $800 million to be split among state and federal governments and $100 million to state consumer protection agencies. Depakote was approved for treatment of epileptic seizures, bipolar mania and prevention of migraines.The firm plead guilty to misbranding the drug by deploying a specialty sales force to peddle it off-label for control of agitation and aggression in elderly dementia patients from 1998 through 2006. Abbott also pled guilty to pushing the drug for use in combination with atypical antipsychotics for schizophrenia from 2001 through 2006, despite clinical trials that failed to establish efficacy for that use.
Vertex announced Monday that its Phase II results of VX-809 and Kallydeco for treatment of cystic fibrosis showed significant improvement of lung function in patients with two copies of the most common mutations in the gene F508del. Full data is expected by the middle of this year. Today’s results were based on patients that reached 56 days of treatment. “Lung function is the single most important marker of disease progression for people with cystic fibrosis, and improvement in lung function is the goal of every new CF therapy,” Michael Boyle, the study’s lead investigator and an Associate Professor of Medicine at John’s Hopkin’s Adult Cystic Fibrosis Center said in a statement. ISI analyst Mark Schoenebaum said in a brief he expects Vertex will slash the cost of the drug regimen from $300,000 to $100,000, and says the combo could hit peak sales of $4 billion a year.
