Headcount: 31,800
Revenues: $11,710 (+4%)
Net Income: $982 (+4%)
R&D: $1,959 (+4%)

TOP SELLING DRUGS

Revenue in Otsuka’s pharmaceutical segment was up 4% for the year at $11.7 billion. In the company’s main area of psychiatry and neurology, sales of antipsychotic agent Abilify Maintena grew 36% to $2.3 billion. Also, the new antipsychotic agent Rexulti was launched in April 2018 for schizophrenia.

Otsuka’s research areas are in psychiatric and neurological diseases, hematological cancers, and kidney, cardiovascular, and infectious diseases. The company is placing an emphasis on discovery and development platforms for antibody development as a means to increase the efficiency of drug discovery across its programs and in addition to conventional R&D processes.

Towards efforts to diversify its portfolio, Otsuka acquired clinical stage biotech Visterra for approximately $430 million. The company’s Hierotope platform, comprised of novel computational and experimental technologies, enables the design and engineering of precision antibody-based therapies that specifically bind to, and modulate, disease targets that are not adequately addressed by current technologies in antibody therapeutics. Visterra’s pipeline includes programs targeting IgA nephropathy and other kidney diseases, cancer, chronic pain and infectious diseases.

During the year Otsuka reinforced its commitment to provide new advancements in digital medicine products and care models to address the needs of patients suffering from severe mental illness. With Proteus Digital Health, based in CA, it signed an expanded global collaboration for the further development and commercialization of a portfolio of medicines including the Abilify Mycite (aripiprazole tablets with sensor) offering, which received NDA approval from the FDA in November 2017.

In another deal Otsuka America and Click Therapeutics signed a collaboration agreement for Otsuka and Click to develop and commercialize a prescription digital therapeutic for treatment of Major Depressive Disorder (MDD). This collaboration will leverage Click’s ability to discover and validate a software application and deploy it commercially, with Otsuka’s expertise in developing approved prescription therapies for patients with serious mental illnesses.

Otsuka says digital therapeutics align naturally with psychiatry and have significant potential to transform mental healthcare. Together, with its partners, Otsuka aims to bring to market a new offering that will provide a novel treatment for patients with MDD.

On the cancer research front, Osaka University and Otsuka Pharmaceutical entered into a licensing agreement for novel CAR-T cell therapy for multiple myeloma. It also teamed up with Takara Bio for co-development and sales rights in Japan to NY-ESO-1 siTCR and CD19 CAR gene therapies.

Expanding its global reach, Otsuka announced during the year the establishment of a new foreign subsidiary, Otsuka Pharmaceutical (Singapore), which held an opening ceremony on in May 2018.

Headcount: 31,800
Revenues: $11,006 (+4%)
Net Income: $1,015 (+23%)
R&D: $1,558 (+4%)
TOP SELLING DRUGS

The Otsuka Group’s pharmaceutical business saw several  major drug approvals this year. In a partnership with Lundbeck, Abilify Maintena (aripiprazole) for extended-release injectable suspension was approved by the FDA for the maintenance monotherapy treatment of bipolar I disorder in adults. The once-monthly injectable formulation was created by Otsuka and co-developed and co-commercialized with Lundbeck.

Also, in collaboration with Proteus Digital Health, the FDA granted approval of a digital medicine system, Abilify Mycite. The drug-device combination product comprises of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker sensor. The Abilify Mycite System includes the Mycite Patch (a wearable sensor, developed by Proteus); the Mycite APP, a smartphone application, used with a compatible smartphone to display information for the patient; and web-based portals for healthcare providers and caregivers that display a summary of aripiprazole ingestion over time. The system is to be used for the treatment of schizophrenia, acute manic and mixed episodes,  maintenance treatment of bipolar I disorder as monotherapy, and major depressive disorder.

Meanwhile, in Japan, regulatory approval was received for the manufacture and sale of Rexulti Tablets (generic name is brexpiprazole) in 1mg and 2 mg dosage sizes, for the treatment of Schizophrenia. Additionally, the FDA approved Otsuka’s Jynarque (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease.

On the collaboration front, Otsuka Pharmaceutical and X-Chem signed a collaborative research agreement to advance the discovery process for new Otsuka drug compounds. Under the terms of the agreement, X-Chem will utilize its DNA-encoded library (DEXTM) screening and informatics platform to search for novel drug leads for several Otsuka discovery targets. X-Chem received an initial research fee from Otsuka upon the signing of the agreement, and is eligible for future payments based on the achievement of research and development milestones, as well as royalties and sales milestones on compounds identified under the collaboration that receive regulatory approval.

In another strategic collaboration, Otsuka partnered with Science 37, a company focused on “site-less” clinical trials, to support efforts to further digitize Otsuka’s mobile clinical study protocols with a strong focus on psychiatry and behavioral health. The collaboration follows an investment in Science 37 by Otsuka as a minority shareholder as part of the final close of a $35 million Series C investment round earlier this year.

Headcount: 11,238
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.

Headcount: 28,000
Revenues: $11,993 (n/a*)
Net Income: $698 (n/a)
R&D: $1,668 (n/a)

TOP SELLING DRUGS 

At the very end of 2014 Otsuka made a move to expand its portfolio and expertise in psychiatric diseases with the $3.5 billion acquisition of Avanir, a Southern CA-based biopharma company specialized in central nervous system (CNS) diseases.

Avanir developed and launched Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) in the U.S. in 2011 as the first and only approved treatment for the neurologic disease pseudobulbar affect (PBA). Sales of Nuedexta in fiscal year 2013 were $94 million, a 50% increase for the year. The acquisition also gives Otsuka the late-stage investigational compound AVP-786 in clinical development to treat agitation associated with Alzheimer’s disease, and Avanir’s clinical development and commercial expertise in neurologic diseases, which supports Otsuka’s expansion strategy in psychiatric diseases.

Otsuka kicked off 2015 by established a presence in Australia with a new office in Sydney as part of an effort to build a larger, long-term presence in Australia and Oceania. These regions have been experiencing single-digit percentage growth in the past several years and were estimated at approximately $13 billion in 2012.

While Otsuka focuses on the development of new drugs for CNS such as schizophrenia, depression and Alzheimer’s disease, it said these are areas where patients in Australia and elsewhere need better treatments.

The opening in Australia represents Otsuka’s 27th affiliate outside Japan, an important milestone the company said as it continues its mission to expand around the globe.

On the product front, during the year Otsuka’s schizophrenia treatment Abilify was granted approval in Japan for a new formulation. Abilify extended–release injectable suspension, for intramuscular use, is administered to the patient just once every four weeks. It first became available to patients in the U.S. in March 2013 and is also available in 18 European countries, starting with the UK in 2014.

Also during the year, the FDA approved Rexulti (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD) and as a treatment for adults with schizophrenia. Rexulti was discovered by Otsuka and co-developed with H. Lundbeck A/S. It will be co-marketed by the two companies and is currently available to patients in the U.S.

At the end of the year, Otsuka and UCB Japan announced the launch of E Keppra for IV Drip Infusion 500 mg (levetiracetam) in Japan. Like its oral formulations, E Keppra IV Drip Infusion will be indicated for partial-onset seizures in epilepsy patients as a temporary alternative when they are unable to ingest oral formulations.

* Due to a change in the fiscal year end to December 2014, percentage changes compared to the previous fiscal year are not applicable.

Headcount: 28,000
Revenues: $10,207 (n/a*)
Net Income: $1,192 (n/a)
R&D: $1,441 (n/a)

TOP SELLING DRUGS   

The Japanese giant Otsuka has shown its face for the first time in the rankings this year. The second biggest pharma company in Japan behind Takeda, it has grown steadily following the joining of the Tokyo Stock Exchange in 2010. This has been facilitated in part by the acquisition of Astex Pharmaceuticals in 2013. Also, in December 2014 Otsuka announced a deal in which Otsuka America, its U.S. subsidiary, would buy U.S.-based Avanir Pharmaceuticals for just over $3.5 billion, and is expected to complete any time now. Avanir, based in Southern California, is a biopharma company specializing in CNS diseases. More recently, Otsuka established Australian ops with a new office in Sydney as part of an effort to build a larger, long-term presence in the region.

Otsuka co-promotes Abilify (arpiprazole) an antipsychotic used to treat schizophrenia with BMS, and this agreement has literally bagged them millions since its launch. However, Abilify lost its patent in 4Q14 and with the longer acting sister Ability Maintena due to come off patent in May 2015 the outlook for sales this year looks bleak, bearing in mind its CNS sales last year dropped by 50%.

Avanir could be Otuskas’ knight in shining armor as it will give them immediate access to Nuedexta, a pseudobulbar affect drug commonly used in neurological conditions. Its sales came in around $100 million last year and merrily growing it is expected to peak at $300 million. On top of this, Otsuka has an Alzheimer’s drug candidate AVP-923, which is showing lots of promise, and if that doesn’t work out there’s always AVP-825, an inhaled migraine therapy. AVP-825 has some wrinkles to iron out having been rejected by the FDA last year; however it could be a very wise purchase, and maybe, just maybe, keep Otsuka in the Top 25 in 2016.

—Adele Graham-King           

* Due to a change in the fiscal year end to December 2014, a transitional period for the change covers nine months from April 1, 2014 to December 31, 2014. Thus, percentage changes compared to the previous fiscal year are not applicable.

Headcount: 25,330
Pharma Revenues: $10,295 (4%)
Total Revenues: $14,738 (1%)
Net Income: $1,481 (27%)
R&D Budget: $2,328 (15%)

Top Selling Drugs

Account for 61% of total pharma sales, down from 64% in 2011.

Headcount: 25,000

Pharma Revenues: $8,440 (9%/1%*)

Total Revenues: $12,755 (9%/1%*)

Net Income: $948 (30%/20%*)

R&D Budget: $1,925 (18%/8%*)

* Converted at avg. exch. rate / based on reported currency (JPY)

Top-Selling Drugs in 2010

Account for 58% of total pharma sales, down from 60% in 2009.

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