Year Established: 1921
Revenues: $10,240 (-16%)
Net Income: $866 (-32%)
R&D: $1,446 (-17%)
TOP SELLING DRUGS
The pharmaceutical business of The Otsuka Group focuses on the priority areas of the central nervous system and oncology. To support global expansion efforts, Otsuka recently announced plans to construct a new pharmaceutical manufacturing facility in Mima City, Japan, which is scheduled to begin operations in 2020. Otsuka currently manufactures pharmaceuticals and ingredients at five factories in Japan.
Also, the recent acquisition of Neurovance, Inc. expands Otsuka’s attention-deficit hyperactivity disorder (ADHD) strategy in the CNS therapy area to develop new products that also address issues of patient compliance and the challenging side effects from existing medications. Neurovance is developing centanafadine, a non-stimulant, triple reuptake inhibitor in patients with ADHD, and it has shown comparable efficacy to stimulant drugs with a potentially lower risk of abuse.
The company’s antipsychotic drug Abilify gained approval in Japan for the additional indication of irritability in pediatric autism spectrum disorder. This is the fourth indication for Otsuka’s top seller, after schizophrenia, bipolar I disorder, and depression.
Under its alliance with development partner Lundbeck, Health Canada approved REXULTI for the treatment of schizophrenia. REXULTI, which became commercially available in Canada this spring, was discovered by Otsuka and will be co-marketed by the two companies. Separately, the U.S. FDA approved a labeling update of REXULTI for maintenance treatment of schizophrenia.
Otsuka and Lundbeck also recently announced positive results from Phase III trials evaluating brexpiprazole in the treatment of agitation in dementia of the Alzheimer’s type, which showed improvements in symptoms relative to placebo.
Additionally, results from the companies Phase III trials of nalmefene in alcohol dependency demonstrated a statistically significant difference compared to placebo for the primary endpoint. This candidate is anticipated as a new, potentially continuous treatment option for the purpose of reducing alcohol consumption and social reintegration.
Among its late stage assets, Otsuka and Proteus Digital Heath have resubmitted an application to the FDA for the first potential digital medicine, which consists of Abilify embedded with the Proteus ingestible sensor in a single tablet, intended for serious mental illness. If approved, the drug/device would provide digital records of medication ingestion and share information with healthcare providers. The NDA has an anticipated action date in 4Q17.