Cell Therapeutics has announced that it has settled all government claims arising out of a Department of Justice investigation into allegations regarding alleged overpayments by Medicare to doctors who prescribed the anti-cancer drug, TRISENOX.
As part of the settlement, the Department of Justice agreed to fully release CTI from all liability for the issues under investigation, including claims asserted in a qui tam lawsuit.
The terms of the settlement contain no admission of wrongdoing by CTI.
The claims at issue, which had been under investigation since August 2004, relate to prescriptions written by physicians for certain off-label uses of the drug TRISENOX(R). CTI had announced the government's investigation in a 2004 SEC filing and has fully cooperated during the investigation. CTI transferred all rights, title and interest in TRISENOX(R) to Cephalon in July 2005.
James A. Bianco, M.D., President and CEO, stated, "We were proud to introduce an important and potentially life-saving treatment for patients with relapsed Acute Promyelocytic Leukemia (APL) and more recently, newly-diagnosed APL, and are disappointed the government chose to ignore the benefits this therapy provides for patients with this blood-related cancer."