Much of the recent buzz in the schizophrenia space has been around Bristol Myers Squibb’s Cobenfy, which last year became the condition’s first newly approved therapy in decades.
But even with the added option, schizophrenia patients are likely to continue cycling through drugs as they grapple with difficult side effects and varying levels of efficacy. Because of these unique treatment dynamics, there’s still room for next-generation options of existing medications to shake up the field — and that’s where Teva Pharmaceuticals sees an opportunity.
In 2023, the pharma giant won an FDA nod for its schizophrenia drug Uzedy, which pulled in higher-than-expected revenue of $117 million last year. Rather than offering patients a new molecule, Uzedy’s breakthrough is tied to its method of delivery.
Developed with a technology Teva licensed from Medincell called SteadyTeq, Uzedy offered the first long-acting subcutaneous form of the decades-old Johnson & Johnson medicine risperidone. The once-monthly, slow-release formulation is designed to keep patients on the medication for longer — a hefty challenge in schizophrenia.
“We know 80% of patients relapse from their medications,” said Heather DeMyers, Teva’s vice president of U.S. innovative medicines. “So when we look at different types of innovative solutions, we look at adherence.”
The company is now looking to repeat that success with the up-and-coming schizophrenia drug TEV-’749, which, like Uzedy, is a subcutaneous long-acting form of a common schizophrenia medication — in this case, olanzapine.
“Olanzapine has been out for 30+ years, but what’s different here is that we’ve used our experience with Uzedy [to] again control the release, which helps patients reach an optimal treatment quickly but also it can help reduce adherence and relapse,” DeMyers said.
Positive late-stage results for TEV-’749 have been rolling in since last year.
Teva’s larger plan
Overall, Teva’s CNS pipeline is set to play a starring role in the company’s quest to drive growth by leaning on four pillars: its generics and biosimilars business, where Teva has long been a powerhouse; operations; branded drugs; and innovative medicines.
This so-called “Pivot to Growth” plan helped the company’s revenue jump 6% to $16.54 billion last year.
In addition to Uzedy, Teva’s innovative medicines portfolio was propelled by sales for Austedo, which skyrocketed 34% last year. The drug scored its first FDA nod in 2017 for a Huntington’s disease indication, has since been approved for a nervous system disorder called tardive dyskinesias, and is now on track to hit $2.5 billion in revenue by 2027, the company said.
Later this year, Teva will have a better sense of whether TEV-’749 could be its next big hit on the mental health scene.
Interim late-stage results for TEV-’749 published in 2024 showed the drug met its efficacy endpoint at eight weeks, which was measured using the common Positive and Negative Syndrome Scale. Critically, there were no incidences of post-injection delirium/sedation syndrome in the treatment’s phase 1 study.
Although rare, PDSS can be life threatening, DeMyers said, and other long-acting treatments carry a black box warning for the side effect. If data from the later-stage studies show lower incidence of PDSS, the improved safety profile would differentiate TEV-’749 on the market.
Teva and Medincell announced earlier this month that they’ve completed the phase 3 trial for TEV-’749. DeMyers said Teva expects to evaluate full results from the study later this year and then assess if and when it will file for regulatory approval.
Teva has yet to offer potential sales guidance for TEV-’749, but DeMyers noted that the oral version of olanzapine currently has about 20% market share in schizophrenia.
The company is also one of several developing longer-acting schizophrenia medications, including Lyndra Therapeutics, which released positive results from its late-stage study of a weekly oral version of risperidone last year.
And although approximately 3.5 million Americans are currently living with the condition, the stigma surrounding schizophrenia can often delay diagnosis or contribute to low medication adherence — a key reason long-acting medications could make a mark.
“Some patients don't want to take an injection or take a pill every day because it reminds them they have the disease,” DeMyers said. “That’s why this could potentially be really different, especially with our subcutaneous technology.”
