Indivior’s plan to strengthen its dominance of the opioid addiction market is falling into place. Two months after winning a crucial legal battle with generics firms in the US over its biggest product, the company has announced a successful pivotal trial of a follow-on asset.
Shares in the Reckitt Benckiser spin-out advanced 9% in London on the news to a record high – the company has more than doubled in value since it floated in December 2014, and is now worth a respectable £2.3bn ($3bn). The pressure is on for that plan to succeed.
The company’s performance since becoming a stand-alone entity suggests that is not an impossible outcome.
It has successfully suppressed the biggest fear about its future – namely generic challenges to Suboxone film, an under-the-tongue formulation of buprenorphine and naloxone that represents about 80% of its revenues. In June it won a suit against Par and Actavis that could keep copycats off the market until April 2024. Other challengers remain – a suit against Teva will hear in November – but the omens are looking good for several more years of exclusivity.
In the meantime Indivior has managed to increase its share of the market with Suboxone film, even amid the intensely competitive environment in the US. Competition from generic versions of older tablet forms and new entrants caused its share of the market to slip from 67% in 2013 to 58% by the end of 2014. Since then Indivior has managed to claw that back to 61%.
The company has proven remarkably successful at switching patients from its older tablet forms of buprenorphine onto the film, which was only launched in 2010. Suboxone sales peaked at $717m in 2012 – this figure also includes some sales of the Suboxone tablet – but generic competition and price cuts taken to retain formulary positions caused sales to decline to $568m last year.
Two successive quarters of sales growth this year, despite little cessation of competitive and pricing pressures, have helped fan investor confidence.
These displays of commercial strength have also bestowed confidence in RBP-6000, a once-monthly injection of a sustained-release formulation of buprenorphine, on which top-line phase III data was released today.
RBP-6000 met both primary and secondary endpoints versus placebo (p<0.0001) in a trial of 489 patients with moderate or severe opioid use disorder, while tolerability also looked good. The agent has fast track designation and could be on the market by the end of 2017.
Sell-side consensus currently sits at $376m for 2022, according to EvaluatePharma, and on a conference call this afternoon chief executive Shaun Thaxter reiterated peak sales guidance for the product of $400m-$700m. He stated “optimism” about the top end of the range.
For this optimism to prove well founded, Indivior will need to persuade physicians and patients of the attributes of this novel administration route. Payers as well of course and here health economic data will be crucial, although arguments about compliance and low abuse potential look fairly easy to make.
Competition from other new sustained release formulations will also emerge – a handful of other injected or implantable assets are approaching the market. And of course RBP-6000 still has to pass FDA muster.
And ironically the brighter the future looks for RBP-6000, the harder generic companies will fight over Suboxone film. They will have little motivation to settle, and potentially delay the launch of their copycat versions, when a valuable replacement product is moving fast towards the market. As such the patent threat hanging over Indivior is unlikely to lessen in the coming years.
Undoubtedly, however, the future is looking bright for Indivior. Opioid addiction and abuse remains a huge public health concern in the US and lawmakers are actively involved in battling the crisis. Only last month the Comprehensive Addiction & Recovery Act (CARA) was enacted, allowing nurses and physician assistants to prescribe addiction medication, while the US health department moved to raise the cap on the number of patients that can be treated by qualified doctors to 275, from 100.
Indivior looks like a well-stocked vessel on a rising tide. No wonder investors are jumping on board.