Indivior Submits Products For Approval Outside The US, Where Pressures Mount
Executive Summary
Indivior is working on receiving ex-US approvals for its opioid abuse treatment products and building its cash reserves but faces future uncertainty over US generic competition and a US Department of Justice legal action.
Indivior PLC is working towards achieving marketing approvals for its buprenorphine containing products, Suboxone Film and its once-monthly injectable, Sublocade, in markets outside the US, a small piece of good news for the embattled addiction therapy company.
The once-monthly Sublocade (buprenorphine subcutaneous) injection is now approved in the US, Australia (approved on 17 July) and Malaysia, and the company is responding to questions from regulators on Sublocade marketing submissions in the EU, Israel and New Zealand. Marketing applications are also underway for Suboxone (buprenorphine/naloxone) Film in the EU (approvals expected in Q1 2020), Canada (submitted in June 2019, approval expected in Q1 2020), Israel and New Zealand.
Further, Indivior’s second product in the launch phase in the US, Perseris (once-monthly risperidone injection), is being prepared for a marketing application in Canada, Indivior's chief scientific officer Christian Heidbreder told analysts in a 1 August call. And INDs are being prepared for its orexin 1 receptor antagonist, C4X3256, a potential non-opioid medication for opioid use disorder, and APV202701A, a selective dopamine D3 receptor antagonist for substance abuse disorder.
The firm is also focusing its R&D efforts on addressing treatment-related questions, such as duration of benefits after the end of treatment. Heidbreder noted that in preliminary data from the RECOVER study, involving patients evaluated 12 months after the last dose of Sublocade, there was a clear relationship between the treatment duration on Sublocade and the level of abstinence, as reported by patients and on a urine drug screen. Final results from the RECOVER study are expected in December.
Less Steep Decline
Another fillip seen in Indivior’s first-half results, reported on 31 July, was that Suboxone Film sales in the US did not decline as quickly as expected after the advent of generic competition earlier this year. (Also see "Alvogen and Dr Reddy’s US Suboxone Rivals Face Off Against Sandoz’ Authorized Generic" - Generics Bulletin, 21 Feb, 2019.)
This unexpected turn of events allowed the UK-headquartered Indivior in the middle of July to revise upwards its financial guidance for the year and also to add to its cash reserves which now total just under $1bn, which will be “very helpful as we face the uncertainties” of the coming year, said CEO Shaun Thaxter in the 2 August call. That said, generic erosion is expected to return to industry norms over the coming months and is likely to account for 80% of the buprenorphine/naloxone film market by the end of the year.
The slower decline in Suboxone film sales in the US and a strong performance from the authorized generic version of Suboxone Film marketed by Sandoz International GMBH led to Indivior’s reported net revenues only declining by 13% to $454m in the first half of 2019 (down 12% at constant currency). Net Sublocade revenues totaled $28m in the first half of 2019 (H1 2018: $2m). Net income declined by 13% to $141m in the first half, following previous cost and headcount cuts that meant adjusted operating expenses totaled $199m in the 2019 first half, compared with $282m in the 2018 first half.
The authorized generic version of Suboxone Film from Sandoz accounted for 49% of the total generic buprenorphine/naloxone film market at the end of the first half, while the US market share for Suboxone Film was 27% at the end of the half. Indivior raised its 2019 guidance on 11 July following the strong revenue performance, and the company now expects net revenues to reach between $670m and $720m in the 2019 full year (up from $525m to $575m) and net income to reach $80m to $130m (the previous forecast ranged from a loss of $40m to net income of $10m).
Indivior is facing legal action from the US Department of Justice involving alleged improper marketing of Suboxone Film and/or tablets in the US, against which on 19 July Indivior filed a motion to dismiss, but a seven-week trial is scheduled to begin on 11 May 2020. The DoJ is seeking to recover $3bn, but Indivior says it has a strong defense against the allegations. (Also see "Indivior Knew Suboxone Film Did Not Have Greater Child Safety Than Tablet, Grand Jury Claims" - Pink Sheet, 10 Apr, 2019.)