If this were to be replicated it would be the best data ever seen in this refractory setting, the company says. Very encouraging phase II data and confirmation that the FDA had granted fast-track status and is happy for the company to repeat its novel trial design across the pivotal programme for ‘5461 has stoked these hopes.Īlkermes is pursuing patients who have already failed on other agents, a setting in which the phase II trial generated a 7-point improvement in the MADRS depression scale. Mr Pops insists that Alkermes is undecided about partnering the promise of ALKS 5461 is adding to the hesitation. The products can improve outcomes – an important theme for physicians and payers these days – and demand is being driven by a realisation that with improved compliance comes better efficacy and, ultimately, reduced healthcare costs as events such as hospitalisations are reduced.īut oral anti-psychotics are entrenched, particularly in the US, and building a market in the presence of well-known generics certainly sounds the territory of big pharma. Long-acting, injectable anti-psychotics is a growth area despite the genericisation of their original oral versions – sales of J&J’s Invega Sustenna, a version of the off-patent Risperdal, topped $1bn last year, its fifth on the market. Abilify, an Otsuka blockbuster, loses patent protection in 2015, and Otsuka and Lundbeck have already launched their own injected form, Abilify Maintena consensus sales forecasts for this already top $1bn by 2017. Phase III data on the Abilify version, aripiprazole lauroxil, will be reported in the next few months, while the novel anti-depressant ALKS 5461 is about to enter pivotal studies. “We’re talking to pharma – there’s a scarcity value for products so it’s worth talking – but we’re loath to break up these assets into too many different sections,” he told EP Vantage. Speaking at the JP Morgan conference in San Francisco this week, Richard Pops, Alkermes’ chief executive, said both had attracted partnering attention, but rights could still be retained. An 18% jump in Alkermes’ share price already this year, after the stock more than doubled in 2013, reveals the expectations that have built around this company’s CNS pipeline – unusual given how renowned this area is for disappointment.īut investors are getting excited about once-monthly injectable Abilify and a novel anti-depressant.
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