18th Jun 2018 06:56
LONDON (Alliance News) - Moody's Investors Service on Friday placed the ratings of two Indivior PLC subsidiaries under review for a downgrade, after the US Food & Drug Administration approved the launch of a generic version of Indivior's main opioid-addiction drug.
Moody's placed the ratings of RBP Global Holdings Ltd and Indivior Finance Sarl under review.
Late last week, the FDA approved a version of Suboxone Film produced by Dr Reddy's Laboratories Ltd, which could lead to a fall of Indivior's sales.
Indivior shares closed 27% lower at 360.50 pence on Friday in response to the news.
Indivior said Friday it believes its Suboxone film medication could see a "rapid and material loss of market share" following the FDA decision.
Indivior said it intends to revisit its 2018 guidance "in light of the changed market circumstances". Its current guidance remains unchanged.
"The launch of a generic version by any company has the potential to lead to a rapid erosion of its revenues and earnings. US sales of Suboxone Film account for about 80% of Indivior's revenue," Moody's said.
Indivior is seeking a court injunction on the generic launch, due to unresolved patent litigation with Dr Reddy's.
The FDA also approved a version of the Suboxone Film by Mylan NV, which however has not announced any planned launch at this point.
In its rating review Moody's will consider several aspects for the downgrade, including whether the injunction is granted and Mylan launches the drug.
"A second entrant would further accelerate the declines in Suboxone Film sales," Moody's said.
Suboxone is used to treat opioid dependence. The FDA said its decision to approve the generic versions would make the medication accessible to those that need it.
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