After final $600M opioid settlement, Indivior looks to the future

UK drugmaker Indivior looks finally to have put years of uncertainty over its exposure to opioid litigation in the US behind it, after agreeing a $600 million settlement.

The deal resolves criminal and civil liabilities faced by the company related to charges it engaged in an illicit nationwide scheme to increase prescriptions of opioid addiction drug Suboxone Film (buprenorphine/naloxone).

It follows a guilty plea by former chief executive Shaun Thaxter last month, and a $1.4 billion settlement agreed with its former parent company Reckitt Benckiser last year.

There had been speculation after the indictment in the case in April 2019 that it could bankrupt the company, wiping three quarters of the value off its share price, but the stock has firmed since and rocketed 38% after the settlement was announced, with further gains today.

Under the terms of the agreement, the Department of Justice will move to dismiss all charges returned by the jury in the lawsuit, according to Indivior.

"We believe the agreement provides greater certainty for all Indivior stakeholders, including the patients around the world who are prescribed our medicines," said new CEO Mark Crossley and interim chair Daniel Tassé in a statement.

An Indivior subsidiary – Indivior Solutions – pleaded guilty on Friday to one felony count in connection with making false statements to promote the Suboxone Film to the Massachusetts Medicaid programme, namely that the product had a lower risk of children taking the drug by accident.

As a result, MassHealth agreed to provide access to Suboxone Film for patients with children under the age of six.

The settlement includes a $100 million payment as soon as it gets the go-ahead from a judge, plus six annual payments of $50 million between 2022 and 2027. The final balance will be due in December 2027.

Indivior also has to disband its Suboxone sales force and remove medical providers from its promotional programmes who pose a high risk of inappropriate prescribing.

The actions "hold accountable entities and individuals that unlawfully marketed opioid-addiction products," said principal deputy associate attorney general Claire Murray.

"When a drug manufacturer claims to be part of a solution for opioid addicts, we expect honesty and candour to government officials, as well as to the physicians and patients making important treatment decisions based on those representations," she added.

The settlement comes after a difficult couple of years for Indivior in which it also suffered a major defeat in the US courts over patent protection for Suboxone Film, opening the door to early generic competition for the drug – which accounts for most of its sales.

It is trying to compensate with the launch of new products such as long-acting schizophrenia therapy Perseris (risperidone), but sales of that product have been modest so far at just $3 million in the first three months of 2020.

It also sells another buprenorphine-based opioid withdrawal product called Sublocade in the US, and recently claimed approval for the drug as Subutex in Sweden, its first European market.

"The incident to which the agreement relates occurred well in the past and does not reflect the values Indivior has strived to demonstrate and uphold during our long history of partnering with healthcare providers, policymakers, and communities to fight the opioid crisis," said Crossley.