20th Jul 2018 07:35
LONDON (Alliance News) - Moody's Investors Service on Friday confirmed the B3 corporate family rating of FTSE 250-listed pharmaceutical firm Indivior PLC, while the outlook remained negative.
In mid-June, Moody's initiated the review of Indivior's ratings for a potential downgrade, after generic drug company Dr Reddy's Laboratories secured a US Food & Drug Administration approval to launch a generic version of Suboxone Film drug in the US.
Suboxone Film is an Indivior drug for opioid addiction which accounts for about 80% of its US sales. Moody's said the launch of a generic version of Suboxone Film by any company has the potential to lead to a rapid erosion of its revenue and earnings.
On Friday last week, the US court granted Indivior a preliminary injunction, preventing Dr Reddy's from selling its generic version of Indivior's Suboxone Film, until sometime in 2019.
However, Moody's noted that the injunction could come off sooner if Dr Reddy's appeal is heard and acted upon by the appeals court.
Meanwhile, Indivior is in the early stages of its launch of another buprenorphine product, Sublocade, which is critical in improving Indivior's revenue diversification, Moody's said, and mitigating the potential loss of earnings from Suboxone Film, if generics are launched.
Suboxone is used to treat opioid dependence. Back in June, the US FDA approved a version of Suboxone produced by Dr Reddy's.
The negative outlook reflects the risk that Indivior is unsuccessful at preventing a large-scale launch of a generic Suboxone prior to Sublocade gaining meaningful market uptake.
Sublocade injection, which is intended to treat moderate to severe opioid use disorder, has already been approved by the US FDA and Health Canada's New Drug Submission.
In addition, Moody's said that Indivior's rating could be downgraded if competitors launch a generic version of Suboxone prior to patent litigation resolution, while slow uptake in the launch of Sublocade could also lead to a downgrade.
However, the rating could be upgraded if the outcome of patent litigation of Suboxone is favourable to Indivior and if there is fast uptake in the launch of Sublocade, the agency said.
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