Indivior’s (INDV) shares have recouped almost all of their recent losses after two US advisory bodies voted to approve the group’s new opioid addiction drug. Eighteen out of 19 members of the two committees voted in favour of RBP-6000, which is now expected to be given the green light by US regulators in November.
This is a mammoth hurdle for Indivior, which has recently been hammered by the threat of competition to its only approved drug, Suboxone. In September, a US court ruled that an unbranded version of Suboxone, made by Indian group Dr Reddy’s, did not breach the group’s patent protection and would therefore be free for approval after completing its final clinical trial. Although analysts don’t expect Dr Reddy’s drug to hit the shelves before the end of 2017, the announcement wiped £1bn off Indivior’s market capitalisation in one day.
And it is not just Dr Reddy’s that is circling Indivior and Suboxone. The group has ongoing patent disputes with Mylan, Actavis, Par, Sandoz, Alvogen and Rhodes Pharmaceuticals, all of which are attempting to launch their own opioid addiction treatments. The expected approval of RBP-6000 is therefore an enormous relief as it will alleviate Indivior’s reliance on US sales of Suboxone, which are expected to drop by as much as 66 per cent with the launch of an unbranded competitor.
RBP-6000 has the same active ingredient as Suboxone – buprenorphine – which has proved in clinical trials to help wean addicts off opioids. Addiction to prescription pain relief medicines has become an enormous problem in the US, with 11.8m Americans engaged in misuse of opioids in the past year, according to a National Survey on Drug Use and Health report. RBP-6000’s method of delivery is thought to be far superior to any other treatment currently on the market as it only has to be taken once a month. Broker Numis thinks the drug could achieve peak annual sales of $1bn.
