Bristol Myers Squibb has targeted launch plan for ‘multi-billion-dollar opportunity’ in Karuna schizophrenia drug

Bristol Myers Squibb spent $14 billion in December on neurology biotech Karuna and its schizophrenia drug-in-waiting KarXT; now the focus is on launch plans and creating a franchise in a drug that could be worth billions to its new owner.

Speaking at the J.P. Morgan Healthcare Conference 2024 in San Francisco, Bristol’s CEO Chris Boerner, Ph.D., set out his plans for KarXT. “We're very excited about the opportunity,” he told investors and journalists at its official presentation at JPM.

“This is going to be a very targeted launch [in schizophrenia]. This will be for those physicians who are treating those patients.” He added, however, that this “is not a massive opportunity in terms of the number of folks that we have to target,” given the relatively low number of schizophrenia patients in the U.S.

He explained that Karuna has already "made good progress in hiring a number of folks, for example, on the market access side.”

“While we're operating as two separate companies today, pending the regulatory approval of this deal, we feel comfortable that we'll be able to build that team. We'll make decisions at risk in order to be ready for that launch.”

Launch could come this year as KarTX has a PDUFA for late September. The drug works as a first-in-class M1 / M4 muscarinic receptor agonist and is seeking FDA approval first in schizophrenia.

This condition is underserved and there are few treatments on the market, given that it remains a severe but typically rare disease, and drugs such as Rexulti from Lundbeck and Otsuka, seek bigger sales from other conditions, namely bipolar disorder and dementia agitation, with a host of older generics also on the market.

Karuna, and now BMS, however, believe its advantages come from its clinical performance paired with the lack of side effects that have plagued existing schizophrenia treatments, including drowsiness and weight gain.

Karuna has also been looking to enlarge KarXT’s use, with ongoing trials testing it as a treatment for psychosis in Alzheimer’s patients and as an adjunctive treatment with another psychosis med, among other uses, something BMS is also keen to push on with.

Boerner said that the schizophrenia programs “are heavily de-risked” because they have the late-stage data to hand.

When it comes to Alzheimer's disease psychosis, for example, “we have reason to believe based on earlier data from another company that showed that this mechanism has the potential to work […] And so, we think that this has got a high probability of success,” he added.

He also sees “an opportunity in Alzheimer's disease agitation, potentially in bipolar.”

If you add it all up, “we think the product has multi-billion-dollar opportunity. Obviously, those later programs, the studies have to read out, but we have a high degree of confidence that given the unique MOA of the asset, it should work.”