23rd Nov 2018 13:48
LONDON (Alliance News) - Indivior PLC's Friday announcement that its Sublocade opioid addiction treatment drug has been approved in Canada ended a complex and challenging week for the pharma company.
Indivior started the week on a positive note, when its schizophrenia medication Perseris became available in the US.
However, Indivior's week soon soured with a late Tuesday announcement that a US court vacated an injunction against launch of generic rival for Indivior's Suboxone sublingual film product, being developed by Dr Reddy's Laboratories Ltd.
The company's Suboxone film contains buprenorphine as its active ingredient. Buprenorphine is used as an opiate replacement in a similar way to methadone.
The Suboxone film franchise held a 57% share of the US buprenorphine market in 2017 and accounts for approximately 80% of Indivior's US sales.
Back in June, the US Food & Drug Administration approved a generic version of the film made by Indian company Dr Reddy's.
Dr Reddy's then announced its intent to launch its generic in the US. The launch, however, was halted first by a temporary restraining order and then by a preliminary injunction.
The injunction was upheld at the end of July but vacated Tuesday. Indivior's stock dropped 47% following the court decision and is down 75% from the start of 2018.
On Wednesday, Indivior expressed surprise and disappointment in the court's decision but said it does not expect the Dr Reddy's generic product to enter the market in 2018.
It therefore maintained its 2018 guidance for net revenue between USD990 million and USD1.02 billion and net income between USD230 million and USD255 million for the year.
However, once the generic is launched, Indivior expects a rapid and material loss of market share.
Broker RBC Capital Markets cut its rating for Indivior to Sector Perform with Speculative Risk from Outperform following the court order. The broker also slashed its price target to 130 pence from 350p.
Closing the week, UK medicine maker had its slow-release opium addiction drug, Sublocade, approved in Canada for use in adult patients with moderate to severe opioid use disorder.
Sublocade also contains buprenorphine, but it is injected rather than being dissolved in the mouth like Suboxone film. Canadian patients taking the drug are required to have been stabilised on a product containing buprenorphine.
Indivior's shares were slightly down at 98.92 pence on Friday, a world away from their Monday opening price of 201.20p.
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