Biocompatibles Inc., a subsidiary of BTG PLC, has agreed to pay $36 million in a settlement arising from the U.S. Department of Justice (DOJ) investigation into the marketing of LC Bead, which is used to treat tumors and other abnormalities. The settlement resolves all allegations relating to an investigation the company, a United Kingdom health care company, revealed in July 2014 over the marketing of the interventional medicine, focusing on the period before BTG acquired Biocompatibles, an oncology products company, in January 2011.
LC Bead works by blocking the arteries that supply blood to hypervascularized tumors, primarily liver cancer, thereby depriving them of nutrients, BTG explained in a Thursday email to Law360. But in some of its promotion activities to U.S. doctors, Biocompatibles misbranded LC Bead as a drug-delivery device, wherein a doctor loads the beads with a chemotherapeutic drug, BTG said. The company noted that this use by doctors is allowed under U.S. law as long as the manufacturer doesn’t promote unapproved uses. In fact, BTG said, drug-loaded beads have become the standard of care – though no product is specifically indicated for this use.
LC Bead is used to block the blood vessels of hypervascular tumors, which are abnormal growths of non-cancerous or cancerous tissue that get bigger because of the overdevelopment of blood vessels that supply the area, and abnormal connections between arteries and veins that can lead to complications, called arteriovenous malformations, according to BTG. The company says the bead is injected into vessels to stop the blood flow that is feeding the tumor or malformation, making it shrink over time.
In April, BTG announced the U.S. launch of the next generation of the bead, called LC Bead LUMI. According to the company, it is the first commercially available radiopaque embolic bead, meaning it blocks radiation instead of allowing it to pass through, making the bead visible during and after treatment. The next month, BTG said it had agreed to buy Galil Medical Inc., a Minnesota maker of oncology products for the treatment of cancers with extremely cold gas, for a consideration that could reach $110 million.
BTG also made a significant acquisition last year, purchasing interventional pulmonology company PneumRX Inc. in an effort to expand its own pulmonology business with the target company’s lung treatment devices. In December 2014, BTG said it would pay up to $475 million for the California-based company.
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