- Alkermes' drug Aristada and Johnson & Johnson's Invega Sustenna showed similar efficacy in a six-month study evaluating them as treatments for acute exacerbation of schizophrenia, according to results announced Tuesday.
- Both drugs met the study's primary endpoint by significantly improving schizophrenia symptoms from baseline. Patients in the Aristada arm started with an initiation dose of the drug plus 30 mg of aripiprazole, the active ingredient in Abilify, followed by a larger dose of Aristada every two months after. Those in the Invega Sustenna arm got a loading dose of the long-acting injectable (LAI) and then a smaller dose every month thereafter.
- In addition to testing safety and efficacy, the Phase 3b trial showed how Aristada could be used as an initiation therapy in hospitals and then as a maintenance treatment in the outpatient setting. Craig Hopkinson, Alkermes' chief medical officer, said the positive results for both Aristada and Invega Sustenna "may be clinically useful in helping to bridge the critical transition between inpatient and outpatient settings of care."
Alkermes has been repositioning itself, with the company moving its business model from royalty-dependent to direct sales.
Part of the strategy involves investing in a few key drugs. They include Aristada (aripiprazole lauroxil), which has racked up a few schizophrenia indications; Vivitrol (naltrexone), which is approved to treat alcohol and opioid dependence; and ALKS-3831, an investigational schizophrenia drug that should reach the market in 2020, according to Marc Goodman of SVB Leerink.
Invega (aliperidone palmitate) is a main competitor to Aristada. Sales for the Invega franchise were $763 million worldwide in the fourth quarter and $2.9 billion across the whole of 2018. Aristada, meanwhile, fetched $48 million and $148 million for those periods, respectively. Even with a projected $210 million to $230 million in 2019, Alkermes' drug still has a lot of catching up to do.
The positive readout from the Phase 3b APLINE study hands Alkermes a small but needed win, given other setbacks in its pipeline.
One of the biotech's drug, ALKS-5461 — in development for the adjunctive treatment of major depressive disorder — received a Complete Response Letter in February, following a 21-2 vote by an FDA advisory panel recommending against approval.
The rejection also came just over three months after ALKS-3831 generated, as Credit Suisse's Vamil Divan called it, "statistically significant but somewhat clinically underwhelming" data in a Phase 3 study.
Alkermes plans to present full study results from the Phase 3b ALPINE study of Aristada at an upcoming scientific meetings.
Though Divan argues Aristada and its initiation regimen, Aristada Initio, aren't as important of catalysts for Alkermes as ALKS-3831, the analyst did acknowledge that the ALPINE data showed "solid efficacy" and a cleaner safety profile for Aristada when it came to injection site pain and weight gain.
"At our Therapeutics Day last week, our panelists had limited enthusiasm towards Initio to date, though they did say that adherence is a key benefit of LAIs and they expect overall use of the LAI class to continue to increase," Divan wrote in an April 10 note.