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Alkermes (NASDAQ: ALKS ) has earned a living making drugs created by other companies stay stable in the bloodstream longer and then splitting the financial rewards with those companies. For the first time, however, the Dublin and Waltham, Mass.-based company looks like it'll soon have a marketed drug it won't have to share with anyone.
Alkermes is announcing today that aripiprazole lauroxil -- its proprietary, once-monthly injectable form of Bristol-Myers Squibb's blockbuster oral schizophrenia drug aripiprazole (Abilify) -- hit its primary and secondary goals in a late-stage clinical trial. The drug reduced patients' schizophrenia symptoms in a statistically significant way compared to a placebo, as measured by two standardized, clinically validated tests. Based on the results, Alkermes will file a new drug application with the FDA during the third quarter.
Alkermes said its drug was well tolerated and had a safety profile comparable to that of Bristol's drug. The most common side effects patients experienced were insomnia, headache, and restlessness. Alkermes only presented top-line results from the trial. It'll release all the data at a future medical meeting.
In the study, 623 schizophrenia patients were randomized and given either a low (441 milligram) or high (882 mg) dose of aripiprazole lauroxil, or a placebo, once a month, for three months. After they were randomized, patients in both the low and high dose group got daily doses of oral aripiprazole for three weeks before stopping. The goal of the study was to see a statistically significant change in patients' scores on the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression scale, two common rating scales used to judge the effectiveness of schizophrenia and other mental health treatments.
Alkermes, of course, has built a steady cash base of more than $500 million in annual revenue deriving royalty streams from companies that use its drug delivery technology to make drugs remain stable in the bloodstream for longer periods of time, enabling fewer injections -- like it's done for Johnson & Johnson with risperidone (Risperdal Consta) and paliperidone (Ingeva Sustanna). Aripiprazole lauroxil, however, is a much bigger opportunity for the company altogether -- it's the first drug Alkermes owns full rights to.
Assuming the FDA gives Alkermes the green light on aripiprazole lauroxil, then the question for the company will become just how big of a seller it has on its hands. Otsuka and Lundbeck are already selling a different, once-monthly formulation of Bristol-Myers' drug -- which has patent protection through 2015 -- and oral antipsychotic drugs still dominate the market. But long-acting injectables are gaining steam. Citing IMS Health data, for instance, Cowen & Co. analyst Anant Padmanabhan wrote in a recent research note that long-acting injectables could double in market share over the next five years due in part to an "increased emphasis" in hospitals on preventing people from relapsing. Leerink Partners analyst Michael Schmidt wrote recently that total prescriptions for long-acting injectables jumped 22 percent over the past 12 months compared to just 3 percent for oral drugs.
"J&J has already established that the long-acting injectable psychotic franchise can drive, in their case, $2.7 billion a year in sales," CEO Richard Pops told me recently. "So there's a proof point here. It's a very logical, medical and commercial opportunity. It's a proven market, a proven added value of the long-acting injectable format, and a drug that's got a $7 billion installed base of use already."
Alkermes is holding a conference call this morning to discuss the study.
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This article originally appeared on Xconomy, along with: