The board of directors at Karuna, a founded entity of PureTech Health, and Bristol Myers Squibb unanimously approved the transaction which also equates to $330 per share.
Karuna is a biopharmaceutical company that discovers, develops, and aims to deliver transformative medicines for people living with psychiatric and neurological conditions. Its lead asset, KarXT (xanomeline-trospium), is an antipsychotic with a novel mechanism of action and differentiated efficacy and safety.
Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults was accepted for review by the US Food and Drug Administration, with a Prescription Drug User Fee Act date of September 26, 2024.
The treatment is also in registrational trials both for adjunctive therapy to existing standard-of-care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease. Bristol Myers Squibb said that it believes the treatment represents a significant revenue contribution opportunity and also sees potential from Karuna’s early-stage and pre-clinical pipeline.
PureTech is a founder of Karuna and co-inventor of the KarXT program. If approved, it will be the third therapeutic candidate to be taken from inception at PureTech to FDA regulatory approval.
Tremendous opportunities in neuroscience
“There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space. We expect KarXT to enhance our growth through the late 2020s and into the next decade,” said Christopher Boerner, chief executive officer of Bristol Myers Squibb.
“This transaction fits squarely within our business development priorities of pursuing assets that are strategically aligned, scientifically sound, financially attractive, and have the potential to address areas of significant unmet medical need. We look forward to welcoming the talented Karuna team to Bristol Myers Squibb.”
The companies say KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments, including no meaningful weight gain, extrapyramidal symptoms, increased prolactin levels, akathisia and/or sedation.
Bill Meury, president and chief executive officer of Karuna Therapeutics, said, “Karuna’s portfolio offers advancements in treatment not seen in many years. With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale and legacy in neuroscience, KarXT and the other assets in our pipeline will be well-positioned to reach those living with schizophrenia and Alzheimer’s disease psychosis. This announcement is a testament to the Karuna team’s talent, hard work, and innovation.”
KarXT is expected to launch in late 2024 in the US as a treatment for schizophrenia in adults. There are approximately 1.6 million people treated for schizophrenia in the US, a significant portion of whom do not respond to currently available therapies and experience unacceptable side effects.
Psychosis affects millions worldwide
“Schizophrenia and Alzheimer’s disease psychosis affect millions of people worldwide, with limited to no treatment options. KarXT’s novel mechanism has resulted in a transformational profile in schizophrenia, with compelling efficacy and a differentiated safety profile,” said Samit Hirawat, executive vice president, chief medical officer, drug development of Bristol Myers Squibb.
“KarXT also has the potential to deliver meaningful benefits to patients as an adjunctive treatment for patients with schizophrenia and as a first treatment for Alzheimer’s disease psychosis.”
A registrational clinical trial is currently underway evaluating KarXT as adjunctive treatment with current standard-of-care agents for the treatment of schizophrenia, with data expected in 2025.
Registrational clinical trials are currently underway evaluating KarXT for the treatment of Alzheimer’s disease psychosis, with data expected in 2026. More than 6 million people are living with Alzheimer’s disease in the US. There are currently no approved treatments for Alzheimer’s disease psychosis.
Bristol Myers Squibb believes KarXT also has potential in additional indications, including bipolar disorder, which impacts approximately 1.4 million people in the US, and Alzheimer’s disease agitation.