Positive phase III data represent a key milestone for what looks set to become a new once-monthly injected alternative to Abilify, but more important still is what they mean for the broader commercial future of its developer, Alkermes.
The project, aripiprazole lauroxil, should now enter a market that, while highly competitive, is expanding. Add to this the recent weakness in Alkermes stock, its Ireland domicile and the fact that two key competitors have no presence in long-acting injectable antipsychotics, and a takeover thesis starts to take shape.
Otsuka’s once-monthly injected version of Abilify was approved a year ago, but aripiprazole lauroxil (ALKS 9070) is different. It is a prodrug of Abilify’s active ingredient, and thus is not a reformulation but a new chemical entity.
That said, it will compete in the same space for long-acting injectable versions of established oral anti-psychotic drugs. This scene is dominated by Johnson & Johnson’s Invega Sustenna and Risperdal Consta, for which somewhat ironically Alkermes supplies the extended-release technology.
The sector is becoming increasingly important since an infrequently injected anti-psychotic can improve compliance considerably versus a daily oral medication. Indeed, J&J looks like it will soon launch a three-monthly version of Sustenna (J&J readies even longer-acting Sustenna for a growing market, March 25, 2014).
Long-acting injectables are expected to dominate the branded anti-schizophrenia market, though this also reflects patent expiries for their oral equivalents.
In the 623-patient phase III study ALKS 9070 met the primary endpoint of bettering placebo in the positive and negative syndrome scale score after 12 weeks. A strong level of statistical significance, with p<0.001, was hit for both the 441mg and 882mg strengths.
Clearly, beating placebo is no great achievement given that Abilify itself is known to work. Moreover, for the first three weeks of the study patients in the active arms were also given daily oral Abilify, while those randomised to a sham injection were given a daily oral placebo.
But the key benefit that ALKS 9070 offers is improved compliance, and UBS analysis said the strength of the efficacy and the relatively good tolerability supported a US filing in the third quarter.
It is interesting that Alkermes has not signed up a commercial licensee – and one is surely vital for ALKS 9070 to have a chance of making a dent in the market.
If J&J has enough on its plate then companies like Lilly or AstraZeneca might make logical partners, since neither is a significant player in the non-oral segment. Lilly’s once-monthly injected form of Zyprexa was a commercial failure, while Astra does not appear to have attempted to expand Seroquel beyond its oral use.
And, if a partnership makes sense, why not a takeover? If the promise of a new entrant in this field is not enough, then surely Alkermes’ Ireland domicile, with its low tax rate, feeds into one of the most important themes of recent mid-sized acquisitions.
Alkermes’ one-year gain of 88% look quite pedestrian by biotech bull market standards, though it cannot be denied that the group trades on a demanding 21x multiple of forecast 2018 earnings. Combined with a relative lack of triggers beyond ALKS 9070 this could dampen the M&A thesis.
Still, recent takeovers by Horizon Pharma, Mallinckrodt and others have shown that price is no object when the promise of tax inversion is thrown into the mix.
Now, if only Alkermes could somehow rebrand itself as a speciality pharma group.
|623 patients, phase III||NCT01469039|