AbbVie, Gedeon Richter Ink Deal to Develop Novel Targets for Neuropsychiatric Conditions

Image Credit: Adobe Stock Images/Lila Patel

AbbVie and Gedeon Richter announced a new collaboration to discover and develop novel targets for neuropsychiatric conditions. According to AbbVie, the new license agreement will expand upon close to two decades of partnering on central nervous system (CNS) projects, including globally launched products, such as Vraylar (cariprazine), and the discovery of investigational drug candidate, ABBV-932, for the treatment of bipolar depression and generalized anxiety disorder.¹

"There remains a large unmet need for people living with neuropsychiatric disorders, making it imperative that we continue to innovate and pursue novel targets and approaches to discover and develop new therapies," said Jonathon Sedgwick, PhD, SVP global head, discovery research, AbbVie, in a press release. "We are excited to expand our longstanding and successful partnership with Richter to help address the complex needs of these patients."

Under terms of the partnership, which includes both preclinical and clinical R&D activities, AbbVie and Gedeon Richter will split financial responsibilities. Richter will receive an upfront cash payment of $25 million, with the potential to receive future developmental, regulatory, and commercialization milestone payments. Further, Richter could also earn sales-based royalties. AbbVie will have worldwide commercialization rights, outside of common Richter markets, including geographic Europe, Russia, and Vietnam.¹

Vraylar has been approved for four indications, including schizophrenia, bipolar I disorder, major depressive disorder (MDD), and as adjunctive therapy to antidepressants for the treatment of MDD. It works through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors. On September 17, 2015, it was first approved by the FDA for treating schizophrenia and bipolar disorders, with the additional indications being approved in 2017, 2019, and 2022.

Common adverse events (AEs) associated with Vraylar include cerebrovascular AEs in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; tardive dyskinesia; late-occurring AEs due to long half-life; metabolic changes; leukopenia; neutropenia; agranulocytosis; orthostatic hypotension and syncope; seizures; and the potential for cognitive and motor impairment. For patients with schizophrenia, common AEs include extrapyramidal symptoms and akathisia. For bipolar mania, AEs include xtrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness. Lastly, in patients receiving adjunctive treatment for MDD, AEs include akathisia, restlessness, fatigue, constipation, nausea, insomnia, increased appetite, dizziness, and extrapyramidal symptoms.²

According to the National Institute for Mental Health, it was estimated that more than one in every five people in the United States were living with a mental illness in 2022, ranging from mild to moderate to severe. This included the categories of Any Mental Illness (AMI) and Serious Mental Illness (SMI), with AMI including any recognized mental illness and SMI consisting of a smaller and more severe subset of mental illnesses.

The study also found that in 2022, the prevalence of AMI was an estimated 59.3 million adults over 18 years of age, representing 23.1% of the United States. Data also show that more females with AMI received treatment than males. For SMI, the number was 15.4 million, with 10.2 million receiving mental health treatment in the past year. In adolescents, 49.5% had any form of a mental disorder, with an estimated 22.2% having severe impairment and/or distress.³

"This new agreement builds on years of successful partnership allowing Richter to further support AbbVie's global ambition in neuropsychiatry and validates the quality of science behind our unique discovery platform," said Gábor Orbán, CEO, Gedeon Richter, in the press release.

References

1. AbbVie and Gedeon Richter Announce New Collaboration for the Discovery and Development of Novel Targets for Neuropsychiatric Conditions. AbbVie. October 24, 2024. Accessed October 25, 2024. https://news.abbvie.com/2024-10-24-AbbVie-and-Gedeon-Richter-Announce-New-Collaboration-for-the-Discovery-and-Development-of-Novel-Targets-for-Neuropsychiatric-Conditions

2. Vraylar FDA Approval History. Drugs.com Accessed October 25, 2024. https://www.drugs.com/history/vraylar.html

3. Mental Illness. NIH. Accessed October 25, 2024. https://www.nimh.nih.gov/health/statistics/mental-illness#:~:text=Prevalence%20of%20Any%20Mental%20Illness%20(AMI),-Figure%201%20shows&text=In%202022%2C%20there%20were%20an,%25)%20than%20males%20(19.7%25).