Alkermes has taken another step toward the market with its long-acting version of the schizophrenia drug Abilify, filing for an approval with the FDA as it lays the foundation for a hoped-for launch in 2015.
The marketing application is built around the pivotal data collected in the once-monthly injectable aripiprazole lauroxil in the Phase III study, which hit its marks on the primary as well as secondary endpoints. The placebo-controlled study demonstrated that both doses used in the trial helped control the symptoms of the disease, as measured by a standard medical scale used to determine how well patients are doing.
Alkermes ($ALKS) plays to win on a series of singles and doubles, avoiding the big home-run swings that often leave other companies empty-handed. In this case, it's also prepping to get into a field that has some heavyweight players already in the market.
Otsuka and Lundbeck got an FDA approval for their once-monthly versions of Abilify, Abilify Maintena, well over a year ago, putting Alkermes well behind the first mover. Johnson & Johnson ($JNJ), meanwhile, has two long-acting injectables, Risperdal Consta and Invega Sustenna, on the market. That franchise is worth $2.7 billion and is growing fast. And Eli Lilly ($LLY) is competing with a low-profile contender of its own.
Undaunted, Alkermes CEO Richard Pops has been confident that the company--which is based in Ireland with big facilities in Waltham, MA--can carve out a place for itself, with the rival drugs helping attract more attention and patients into the market niche.
"We have designed aripiprazole lauroxil to be a differentiated treatment option for schizophrenia, with a ready-to-use format with multiple dosing options, to help meet the individual needs of patients and their healthcare providers," said Pops in a statement. "These attributes, together with the robust clinical data observed in the pivotal study, position aripiprazole lauroxil to be a meaningful new entrant in the growing long-acting injectable antipsychotic market, and we look forward to working with the FDA to bring this important new medication to patients and physicians as quickly as possible."
- here's the release