A federal grand jury in Virginia issued the company with an indictment on Tuesday night, which included 28 charges, including healthcare fraud, wire fraud and mail fraud.
Indivior said it was “extremely disappointed” by the DoJ’s claims, which it insists are “wholly unsupported by either the facts or the law”.
The charges relate to a long-running Department of Justice investigation which claimed Indivior engaged in a fraudulent marketing scheme to boost prescriptions of Suboxone – its blockbuster opioid addiction treatment.
According to the indictment, Indivior marketed its star drug as safer and less abusable than other treatments, deceiving healthcare providers and allowing the company to rake in billions of dollars in extra sales.
The firm, which was spun out of Reckitt Benckiser PLC (LON:RB.) in 2014, has also been accused of boosting profits through its: ‘Here to Help’ scheme which prosecutors claim connected patients to doctors known to prescribe opioids “at high rates and in a clinically unwarranted manner”.
The DoJ also alleged that Indivior sought to delay generic competitors from entering the market by replacing Suboxone tablets with an under-the-tongue film just as the tablet patent was about to expire.
At the time, Indivior cited concerns over the potential for children to get hold of the pills but the DoJ argued that executives knew the real reason was to push back approval for generic rivals.
Indivior not backing down
Indivior said it would “vigorously” defend contest the allegations as it published an eight-page rebuttal of the DoJ’s case.
“We are extremely disappointed in this action by the Justice Department, which is wholly unsupported by either the facts or the law,” read the statement.
“Key allegations made by the Justice Department are contradicted by the government's own scientific agencies, they are almost exclusively based on years-old events from before Indivior became an independent company in 2014, and they are wrong.
“The department has apparently decided it would rather pursue self-serving headlines on a matter of national significance than achieve an appropriate resolution, but we will contest this case vigorously and we look forward to the full facts coming out in court.”
Indivior shares have plunged over the past year as generic competitors to Suboxone enter the market.
The stock lost another three-quarters of its value on Wednesday, falling to 33.2p – the lowest it has ever been.