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| Richard Pops--Courtesy of Alkermes |
Alkermes has crossed the finish line in a Phase III schizophrenia study of a long-acting version of Abilify, picking up the statistically significant results needed to back a new drug application later in the year. The company's shares ($ALKS) shot up 10% in early trading Tuesday.
The company--which is domiciled in Ireland with facilities in Waltham, MA--is sticking with topline data for now, adding that both doses of aripiprazole lauroxil passed the test for statistical significance. The plan now is to push ahead with what Alkermes CEO Richard Pops tells FierceBiotech is "clearly a blockbuster scale opportunity," with plans to hire a sales force of about 150 to market the drug, provided they win an FDA OK in 2015.
The drawback is that Alkermes isn't alone in doing the same thing. More than a year ago Otsuka and Lundbeck got an FDA approval for their once-monthly versions of Abilify, Abilify Maintena, putting Alkermes well behind the first mover. Johnson & Johnson ($JNJ), meanwhile, has two long-acting injectables, Risperdal Consta and Invega Sustenna on the market. That franchise is worth $2.7 billion and is growing fast, And Lilly ($LLY) is competing with a low-profile contender of its own.
Pops, though, doesn't sound in the least bit daunted by the major league competition. He sees it as an advantage.
"More entrants drive more awareness," he says, which will push utilization of Alkermes' new drug. That's a particularly important issue in the U.S., he adds, where compliance rates in the patient population are well behind Europe. Every time patients afflicted with schizophrenia suffer a relapse, they lose functional abilities that can't be regained. And that makes compliance supremely important.
Alkermes plans to sit down with regulators in Europe, but Pops says the company will need to do another study there, which is likely to be a head-to-head trial with a standard therapy to help establish pricing. Pricing guidance in the U.S. will come closer to launch, he adds.
For Alkermes, the successful Phase III helps spotlight a strategy for using its delivery know-how to come up with me-better therapies. The low/high dose approach, for example, should help distinguish this drug, as well as the use of a prefilled syringe to facilitate the use of the therapy. Targeting new versions of an existing drug also significantly derisks CNS projects, which have had a low rate of success in recent years. But it's also a watershed moment for Alkermes, says the CEO, which has in the past allied with Big Pharma companies to develop new products.
Alkermes is now going it alone, taking on the risk of commercialization while expecting to earn some big rewards for it as well.
"A once-monthly version of aripiprazole with multiple dose strengths would be a welcome addition since it would enhance current treatment options and provide dosing flexibility. These data come at a time when the treatment landscape for schizophrenia is evolving; more physicians are now recognizing the benefits of long-acting injectable antipsychotics and considering their use earlier in disease progression." said Henry Nasrallah, who chairs the Department of Neurology and Psychiatry at Saint Louis University School of Medicine.
- here's the press release
Special Report: 2013's 25 most influential people in biopharma - Richard Pops