Teva has taken a step toward winning approval for a long-acting injectable to challenge Johnson & Johnson for the schizophrenia market. The FDA has accepted a filing for approval, giving Teva a shot at mounting a push to claim more than 10% of the market starting next year.
A 2022 launch has been on the cards since January, when Teva revealed a phase 3 clinical trial of its extended-release formulation of the antipsychotic drug risperidone had met its primary endpoint. At that time, Teva said it was exploring options for a potential filing. Teva ultimately filed with the FDA using the phase 3 data and interim results from an ongoing trial of the long-term effects of the drug.
The filing covers risperidone, the active ingredient in J&J’s off-patent oral antipsychotic Risperdal, in an injectable formulation made using MedinCell’s BEPO technology. MedinCell creates long-acting injectable products by formulating active ingredients so they create a depot upon administration.
While the active ingredient is old, the application of the drug delivery technology is new. Teva thinks the work done to develop the long-acting mechanism and to create a subcutaneous formulation puts it in a position to compete on benefits, not price, with branded competitors.
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Talking to investors in July, CEO Kåre Schultz said Teva plans to launch the risperidone formulation at a price that is comparable to branded, patent-protected long-acting injectables. Schultz is aiming to take 10% of the market. Given J&J makes billions of dollars a year from its schizophrenia franchise, Teva will generate significant sales if it captures 10% of the market without undercutting on price.
“I think it's quite a big opportunity, because the pricing on LAIs is quite stable and good in the marketplace. And the pricing of LAI has really not gone generic for the new and better products, so that means that we will be launching probably with a price that's the average price of branded patent-protected LAIs,” Schultz said.