Anti-schizophrenia drug Cobenfy could treat Alzheimer's

Bristol-Myers Squibb believes Alzheimer's is the largest market for its recently approved anti-schizophrenia drug, Cobenfy, which it hopes to eventually generate billions of dollars in revenue.

In an interview, company executives said each treatment use they are studying for Cobenfy has multimillion-dollar potential, including Alzheimer's disease psychosis, Alzheimer's agitation and cognition, bipolar disease and autism. But Alzheimer's is “a really big market here,” Bristol Myers Squibb Chief Financial Officer David Elkins told CNBC Tuesday at the JPMorgan Health Care Conference in San Francisco.

There are nearly 6 million patients in the United States with Alzheimer's, and about half of them have psychosis or symptoms such as hallucinations and delusions, Elkins said. Cobenfy could be the first drug approved specifically for Alzheimer's-related psychosis, marketing chief said Officer Adam Lenkowsky.

Atypical antipsychotics (drugs used to treat a variety of psychiatric disorders) are often used to treat psychosis in Alzheimer's patients, although they are not approved for that purpose. But those treatments can increase the risk of death, and Cobenfy does not, according to Bristol Myers Squibb.

Meanwhile, Alzheimer's agitation, a symptom that can make a patient feel restless and worried, is estimated to affect between 60% and 70% of patients with the disease, according to some studies.

Bristol Myers Squibb said Monday it plans to release data from the initial late-stage trial of Cobenfy in the treatment of Alzheimer's-related psychosis during the latter part of the year, which is earlier than expected. The company also expects to begin phase three trials in Alzheimer's agitation, Alzheimer's cognition and bipolar disorder in 2025, while studies in autism will begin in 2026.

JPMorgan analyst Chris Schott expects Cobenfy sales to reach around $5 billion by 2030, with peak sales potential in the range of $10 billion across multiple treatment uses, according to a research note. published on Tuesday. This is a boon for Bristol Myers Squibb as it faces pressure to make up for potential lost revenue from best-selling treatments whose patents are set to expire.

It's a full-circle moment for Cobenfy, which became the first novel type of treatment for the estimated 3 million American adults with schizophrenia in decades after its approval in September. The drug comes from Bristol Myers Squibb's massive acquisition of biotech company Karuna Therapeutics in late 2023.

But the drug's roots are in the treatment of Alzheimer's.

Eli Lilly originally tested a part of the drug, xanomeline, in the 1990s to reduce cognitive decline before shelving it due to serious side effects such as nausea, vomiting, diarrhea and constipation. Xanomeline activates certain muscarinic receptors in the brain to decrease dopamine activity without causing the side effects associated with antipsychotics.

Andrew Miller, founder and former president of research and development at Karuna Therapeutics and now an advisor at Bristol Myers Squibb, saw xanomeline's potential in neuroscience and theorized combining xanomeline with a second existing drug, trospium, to reduce those side effects. . He then launched Karuna to develop the combination as a treatment for schizophrenia.

Other innovative treatments for Alzheimer's have recently appeared on the market, including biogen and Eisai's Leqembi and Eli LillyIt's Kisunla. Those treatments work in part by removing toxic plaques in the brain called amyloid, a hallmark of Alzheimer's, to slow the decline of memory and thinking in patients in the early stages of the disease.

But as people progress in their illness, they experience symptoms such as psychosis and agitation, said Bristol Myers Squibb's Elkins.

“That's where Cobenfy fits in,” he said. “If you can get rid of the psychosis, the agitation, people's cognition improves. Imagine, for caregivers and the healthcare system in general, the impact this medication could have for those patients and their loved ones. It's really exciting when you think about it in that context.”