By Noor Zainab Hussain, Pushkala Aripaka and Nate Raymond
(Reuters) - Reckitt Benckiser has agreed to pay up to $1.4 billion to resolve U.S. claims that its former pharmaceuticals business Indivior before it was spun out of the company carried out an illegal scheme to boost sales of an opioid addiction treatment.
The settlement, the largest by any company related to the U.S. opioid epidemic, resolved long-running probes by the U.S. Justice Department and the Federal Trade Commission into the companies' marketing and sales of Suboxone Film.
The deal came after Indivior in April was indicted and accused of deceiving doctors and healthcare benefit programs into believing Suboxone Film, itself a form of opioid, was safer and less susceptible to abuse than similar drugs.
The indictment said Indivior also used an internet and telephone program touted as a resource for opioid-addicted patients to connect them to doctors it knew were prescribing Suboxone and other opioids at high rates and in suspect circumstances.
The Justice Department said the scheme began before Indivior spun out of Reckitt in 2014 and resulted in thousands of opioid-addicted patients using the drug.
Opioids, including prescription painkillers and heroin, played a role in a record 47,600 U.S. overdose deaths in 2017, the U.S. Centers for Disease Control and Prevention has said.
Reckitt was not indicted like Indivior, but the department last year joined several whistleblower lawsuits alleging the British company improperly marketed the drug.
As part of Thursday's settlement, Reckitt entered into a non-prosecution agreement and agreed to pay nearly $1.35 billion to resolve the Justice Department's criminal and civil claims.
It will also pay $50 million to resolve FTC claims that it engaged in anticompetitive activities aimed at impeding competition from generic versions of Suboxone.
Reckitt said in a statement that it "acted lawfully at all times and expressly denies all allegations that it engaged in any wrongful conduct." But it said its board had decided the settlement was in the company's best interests.
Slough, England-based Indivior has pleaded not guilty to conspiracy and fraud charges. In a statement, it acknowledged Reckitt's settlement but said it had no new information on the case. Its trial in federal court in Abingdon, Virginia is set for May.
'CLARIFIES LEGAL ENVIRONMENT'
Shares in Reckitt, whose products range from Mucinex cold medicine and Lysol cleaners, closed up 2.5%.
While the settlement is significantly higher than the $400 million that the consumer goods group had set aside to cover the cost of the investigations, analysts said it could allow the company's new chief executive to focus on a turnaround plan.
In an effort to regain investor confidence after setbacks including a safety scandal in South Korea, a failed product launch and a cyber attack, Reckitt's outgoing boss Rakesh Kapoor launched a plan to split the group into two business units – one for health and one for hygiene and home products.
Investors had feared the U.S. probes could hinder the transformation. Analysts at JP Morgan wrote in a note that settlement "clarifies the legal environment for RB and should allow the new management to focus on the RB 2.0 transformation."
While welcoming the settlement, AJ Bell investment director Russ Mould said the cost could limit incoming CEO Laxman Narasimhan's ability to undertake much-needed investment in Reckitt's brands.
"The danger is that Narasimhan will be operating with one hand tied behind his back," he said.
The company said it would increase its provision related to the investigations to $1.5 billion to cover both the cost of the settlement and "any remaining litigation exposures." It said the deal would be funded through existing borrowing facilities and cash generation.
Separately, Indivior also raised its full-year profit and revenue guidance after Suboxone lost market share at a slower pace than expected. Its shares closed 6.73% higher.($1 = 0.7981 pounds)
(Additional reporting by Siddharth Cavale in Bengaluru; Editing by Edmund Blair, Mark Potter and Susan Thomas)