Otsuka stares down another rival with FDA approval for Alkermes' long-acting Abilify

It's been a tough year for Otsuka with its antipsychotic franchise, with the FDA earlier this year approving generics of its blockbuster Abilify and a federal judge subsequently shooting down the company's exclusivity for the med. Now the company is facing more bad news, as Alkermes ($ALKS) scored FDA approval for a long-acting injectable version of Abilify as it vies for a bigger spot in an increasingly crowded antipsychotic market.

The Dublin-based drugmaker plans to launch its Aristada (aripiprazole lauroxil) injection for schizophrenia "immediately," it said in a statement. The FDA signed off on the drug citing data from a Phase II study, which showed that Aristada helped reduce symptoms of the disorder compared to a placebo. The drug can be given once-monthly or every 6 weeks--the first atypical antipsychotic with this distinction, the company said in a statement.

Additional dosing options give Aristada some ammo as it competes head-to-head with Otsuka and Lundbeck's long-acting schizophrenia injection, Abilify Maintena. Unlike Abilify Maintena, Aristada "covers the entire spectrum of available oral Abilify doses," Leerink analyst Michael Schmidt said in a note to clients. And the company is expected to roll out an 8-week formula of Aristada in 2017, he added, which could add to its haul.

But Alkermes is not stopping there. The company also plans to explore an indication for the drug for treatment-resistant depression, which could "unlock a much larger opportunity" for Aristada, Schmidt said--and give Otsuka a run for its money. As the long-acting injectable market continues to expand, the drug is "well positioned as a key near-term growth driver" for Alkermes, he added.

Meanwhile, Otsuka has been working hard to staunch the bleeding after the FDA in April approved Abilify generics from companies such as Alembic Pharmaceuticals, Hetero Labs, Teva ($TEVA) and Torrent Pharmaceuticals. In July, the company got FDA approval for antipsychotic Rexulti, which is pegged to bring in $1.4 billion in peak sales. And analysts still peg peak sales for Abilify Maintena between $500 and $1 billion, giving Otsuka and marketing partner Bristol-Myers Squibb ($BMY) some light at the end of the tunnel.

Other drugmakers such as Johnson & Johnson ($JNJ) and Allergan ($AGN) are charging ahead with rival meds to cash in on the rapidly growing antipsychotic market. J&J's once-monthly antipsychotic, Invega Sustenna, is already bringing in blockbuster numbers. Earlier this year, the company nabbed FDA approval for a quarterly formula of its once-a-month med, giving the brand another boost after J&J lost its Invega patent last year.

Last month, Allergan snagged FDA approval for its antipsychotic, Vraylar, weeks after Abilify generics were released. The FDA based its approval on three, 6-week clinical trials which showed that the drug reduced the symptoms of schizophrenia compared with a placebo in 1,754 study participants.

- read Alkermes' statement

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