Otsuka’s Longer-Acting Schizophrenia Injection to Offset Abilify Patent Loss

 While Otsuka Pharmaceutical can expect to a drop in sales as its schizophrenia therapy Abilify Maintena (aripiprazole) loses its market exclusivity later this year, the recently approved longer-acting formulation Abilify Asimtufii will help the company buttress its revenues, according to a report Wednesday from data analytics and consulting firm GlobalData.

Abilify Maintena—approved in 2013 as a once-monthly intramuscular injection for the treatment of schizophrenia—is set to lose its patent protections in the U.S. and in Europe in October 2024.

GlobalData estimates that losing its market exclusivity will hurt Abilify Maintena’s sales by 12% from 2024 to 2025, and will continue to “plummet” through 2029, according to the report. Abilify Maintena annual revenues are likely to drop below $1 billion by 2027 or 2028, before dipping to around $700,000 by 2029.

“The upcoming patent expiry of Abilify Maintena is a critical moment for Otsuka, highlighting the challenges inherent in the pharmaceutical industry’s lifecycle management,” Eleni Tokali, pharma analyst at GlobalData, said in a statement.

Still, the Japanese multinational has demonstrated “adaptability in the face of patent expirations” by developing new formulations of its schizophrenia therapy, while opening up a “robust pathway for sustained growth in mental health solutions,” Tokali added.

This novel formulation is Otsuka’s Abilify Asimtufii, which it developed in partnership with Lundbeck and won the FDA’s approval in April 2023.

Compared with Abilify Maintena, Abilify Asimtufii is a longer-acting injectable and only needs to be administered once every two months. The pivotal 031-201-00181 study, which supported its approval, showed that a 960-mg dose of Abilify Asimtufii could achieve similar plasma levels of aripiprazole as Abilify Maintena.

The safety profiles of the two formulations were also largely similar. Even at multiple doses, Abilify Asimtufii was well-tolerated.

Following its approval, Otsuka and Lundbeck made Abilify Asimtufii available in 960-mg and 720-mg prefilled syringes, both of which can achieve sustained plasma levels of aripiprazole.

Beyond the reformulated Abilify Asimtufii, Otsuka is also looking to preserve its revenues with Rexulti (brexpiprazole), another Lundbeck-partnered asset that was approved in May 2023 to treat agitation associated with dementia in Alzheimer’s disease patients. Rexulti is also approved for major depressive disorder and schizophrenia.

On Monday, however, Otsuka reported that its potential successor to Rexulti—an investigational two-drug combo dubbed AVP-786—failed its Phase III trial in agitation in Alzheimer’s. Otsuka will continue to dig into the data of the study to figure out a way forward for AVP-786.

https://www.biospace.com/article/otsuka-s-longer-acting-schizophrenia-injection-to-offset-abilify-patent-loss-globaldata/