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Indivior boosted as opioid addiction rival trips over regulatory hurdle
Shares in Indivior received a shot in the arm on Monday after news emerged over the weekend that a rival had hit a regulatory hurdle.
Following approval in December from the US Food and Drug Administration for Indivior's Sublocade, a once-monthly injectable treatment for moderate to severe opioid addiction disorder, sector peer Camurus announced that its rival product had not been approved by the FDA.
The FDA sent complete response letter to Camurus detailing issues with its CAM2038 product, like Sublocade also an injectable buprenorphine, which the company claims should not require any further clinical trials.
There was little detail within the statement other than to inform that Camarus and US marketing partner Braeburn will be working with the FDA to answer key concerns.
Analysts RBC Capital Markets said that it appeared this would results in a launch delay of "at least a year". Broker Numis said the delay could range from three to 10 months "depending on the extent of questions" from the regulator.
"We view this news as a slight positive, albeit with Indivior now responsible for all the heavy lifting associated with a new product/ concept launch," said Numis, noting that conversely, Camurus may well benefit from launching into a better-established premium priced market that Indivior will build through 2018.
RBC agreed it was a positive for Indivior, with a 12-plus month's head-start to entrench its position ahead of the launch of CAM2038.
Given CAM2038 is only delayed rather than turned down, RBC saw this as underpinning its forecasts for Sublocade's launch but we provides "no material valuation benefit yet, unless the delay is more material in length".
Indivior's full year results are due on 15 February.