J&J eyes long-acting boost for Invega franchise with quick FDA look at new formula

Johnson & Johnson's ($JNJ) once-a-month antipsychotic med Invega Sustenna is already bringing in blockbuster-plus sales for J&J, and if the company has its way, a new, even longer acting formula will give the franchise a bigger boost.

The FDA granted the pharma giant priority review for a three-month dosing option for Invega (paliperidone), shaving four months off its usual review time and potentially allowing J&J to kick off marketing for the drug as early as mid-2015, PMLive reports. Invega Sustenna, approved to treat schizophrenia and bipolar disorder, racked up $418 million in worldwide sales during the fourth quarter, and snagged $1.5 billion in 2014--a 27.2% increase over last year. The original, short-acting formula of the drug, Invega, brought in $161 million in Q4 and $640 million last year--a 9.8% jump.

The quarterly formula could bolster an already successful line of antipsychotics and help keep the Invega brand alive long after the original version of the drug goes off patent. Pharma market research firm Decision Resources predicts that a three-monthly formulation of paliperidone will be one of the main drivers of growth in the schizophrenia market, which is forecast to grow from $5.9 billion in 2013 to $6.4 billion in 2017 as new products launch.

But J&J is not the only company looking for its piece of the long-acting antipsychotic pie. Lundbeck and Otsuka boast their own once-a-month antipsychotic, Abilify Maintena, approved in late 2013. Analysts set peak Abilify Maintena sales between $500 million and $1 billion. Eli Lilly ($LLY) sells a long-acting version of its blockbuster Zyprexa, dubbed Zyprexa Relprevv, which has helped keep that brand alive after the original pill went generic--albeit as a faint shadow of its former self. The once-megablockbuster franchise brought in $257.4 million in worldwide sales during the company's third quarter and racked up $784.2 million in sales for the first 9 months of 2014.

J&J could also face some competition from Alkermes ($ALKS), which is hard at work on its own injectable antipsychotic. The Dublin-based company asked the FDA to approve its long-acting formula of Abilify (aripiprazole), touting results from a Phase III study that found its once-monthly injectable helped control schizophrenia symptoms.

J&J will need as much help from new drugs as it can get as competition rears up for other meds, including the hep C blockbuster Olysio. The drug posted $2.3 billion in global sales for 2014, a sizeable chunk of the company's overall drug revenue, and won a new FDA indication in November as a combo treatment with Gilead Sciences' ($GILD) Sovaldi. But the advent of Gilead and AbbVie's ($ABBV) hep C combo pills could quickly eat away at the drug's market share.

- read the PMLive story

Special Reports: The top 10 pharma companies by 2013 revenue - Johnson & Johnson | The top 10 patent losses of 2015 - Abilify

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