The pharmaceutical business of The Otsuka Group focuses on the priority areas of the central nervous system and on- cology. 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 cen-tanafadine, 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 na-lmefene 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. CP
Abilify irritability in pediatric autism spectrum
Mikeluna glaucoma and ocular hypertension
Samsca/JINARC hepatic edema, cardiac edema
Abilify Maintena bipolar I / depot injection
Zosyn complicated skin, soft tissue infections
PHASE IIB AND BEYOND
Rexulti major depressive disorder / oral, agitation
associated with dementia
ASC-01 major depressive disorder
AVP-786 agitation associated with dementia
Lu AA36143 alcohol dependence
Lonsurf colorectal cancer, gastric cancer
TAS-118 pancreatic cancer, gastric cancer
SGI-110 acute myeloid leukemia, myelodysplastic
Samsca/Jinarc autosomal dominant polycystic kidney
AKB-6548 anemia associated with chronic kidney
OPC-12759E dry eyes
SGI-110 myelodysplastic syndrome
EARLY RESEARCH PROJECTS
Rexulti schizophrenia / depot injection
Lu AF20513 Alzheimer’s demetia / injection
ASTX660 solid tumors, lymphomas
OPB-111077 solid tumors
TAS-117 solid tumors
TAS-119 solid tumors
TAS3681 prostate cancer
OCV-C02 colorectal cancer
TOP SELLING DRUGS
DRUG INDICATION 2016 SALES (+/-%)
Abilify schizophrenia $817 -72%
Samsca/Jinarc hyponatremia $419 18%
Abilify Maintena schizophrenia $490 41%
Headquarters: Tokyo, Japan
YEAR ESTABLISHED: 1921
REVENUES: $10,240 (-16%)
NET INCOME: $866 (-32%)
R&D: $1,446 (-17%)