Bristol Myers Backs Cobenfy Amid Trial Setback and Market Hesitation

Highlights

• Bristol Myers remains optimistic about Cobenfy despite a failed phase 3 trial in adjunctive schizophrenia treatment.
• CEO Chris Boerner cites strong physician feedback, particularly for cognitive benefits.
• Commercial uptake has reached 30,000 prescriptions, though weekly numbers plateaued in May.
• Physician response to efficacy is mixed, with concerns over real-world performance and cost.
• BMS is expanding Cobenfy’s development pipeline with trials in Alzheimer’s psychosis, bipolar disorder, and autism-related irritability.
• Future trial readouts are expected annually through the end of the decade, positioning the drug for long-term growth.

Company Maintains Confidence Despite Trial Failure

Bristol Myers Squibb remains confident in the long-term prospects of its novel antipsychotic drug Cobenfy, despite a recent setback in a key clinical trial and signs of waning market momentum. Acquired through a $14 billion deal, Cobenfy failed in a phase 3 trial evaluating its effectiveness as an adjunctive treatment for inadequately controlled schizophrenia. Goldman Sachs analyst Asad Haider also noted a slowdown in new-to-brand prescription growth as the second quarter concludes.

Still, CEO Chris Boerner and Chief Commercialization Officer Adam Lenkowsky expressed optimism during their remarks at the Goldman Sachs Annual Global Healthcare Conference. Boerner emphasized positive feedback from physicians regarding Cobenfy’s efficacy across positive symptoms, negative symptoms, and cognitive benefits:“We’ve got very good feedback from physicians in terms of what they’re seeing on positive symptoms, negative symptoms and … the cognitive benefits,”Boerner said. He added that several clinical programs are underway or planned to extend the drug’s use beyond schizophrenia.

Commercial Impact and Physician Reception

While the failure of the Arise trial is under review, Lenkowsky assured that it would have“zero impact”on Cobenfy’s commercial outlook“in the short term or in the long term.”He also clarified that no sales forecasts were tied to the adjunctive indication, and awareness of the trial failure is currently limited to investigators.

Despite the trial outcome, two psychiatrists cited in a May 5 note by Leerink Partners still foresee Cobenfy’s use in adjunctive therapy, citing the absence of approved alternatives. However, they cautioned that payers might deny coverage for this use.

Prescription Trends and Market Dynamics

According to Lenkowsky, Cobenfy’s launch remains on track, having surpassed 30,000 total prescriptions since its FDA approval in late September. However, Leerink Partners’ analysis of IQVIA data revealed stagnation, with weekly scripts hovering around 1,800 through most of May before dipping to 1,700 during Memorial Day week.

Lenkowsky acknowledged challenges in changing longstanding prescribing habits tied to generic dopamine D2 receptor antagonists. He noted,“We’ve got a very robust plan in place right now... we’ll be upsizing our teams in the near future as well to make sure we’ve got the right reach and frequency.”The company is also conducting studies to assist physicians in transitioning patients and managing potential side effects.

Mixed Real-World Feedback

While physician feedback has generally highlighted Cobenfy’s cognitive benefits, not all reviews have been favorable. According to Leerink, one expert observed limited efficacy in patients unresponsive to other treatments. The physician raised concerns about the drug’s cost, twice-daily dosing, and whether trial results would translate to real-world success:“He questioned whether Cobenfy’s real-world efficacy will turn out to be robust enough to justify its [twice-daily] dosing and high cost,”the analysts noted.

Pipeline Expansion Beyond Schizophrenia

Bristol Myers is broadening Cobenfy’s scope with clinical trials targeting Alzheimer’s disease psychosis, where approximately half of the six million patients experience hallucinations and delusions. The first study in this area, Adept-2, is expected to report results this year. Adjustments have been made to the drug’s formulation in response to concerns about gastrointestinal side effects in Alzheimer’s patients, particularly reducing the trospium component. Leerink analysts, however, warned that this modification could pose new tolerability issues.

In addition, BMS is launching seven new phase 3 trials covering Alzheimer’s agitation and cognition, bipolar disorder, autism-related irritability, and a new formulation of Cobenfy. According to Lenkowsky, these trials are expected to yield annual data through the end of the decade, potentially making Cobenfy a“meaningful contributor to growth for the company in the back end of the decade and beyond.”