Otsuka's Two Core Businesses

Helping to cure disease and protect health
— a holistic healthcare company concerned about the entire body

Pharmaceutical Business

Providing Breakthrough Treatments for Patients Around the World

Otsuka Pharmaceutical is dedicated to the research & development of highly-innovative drugs and diagnostics. Leveraging our research culture of curiosity, determination and unconventional thinking, we strive for solutions that only Otsuka can deliver, to improve the health of people across the world.
Our R&D philosophy places emphasis on encouraging individual researchers to take the untraveled path, pursuing fresh ideas within a collaborative, accommodating environment. Supported by the global integration of our research and development institutes in Asia, the US and Europe, the result has been epoch-making drugs in the following fields.

Central Nervous System (CNS): The antipsychotic drug ABILIFY, which is available in 60 countries and regions, has reached 7th place*1 in the global ranking of drug sales. In the US, growing prescriptions for bipolar disorder and as an adjuvant therapy for major depression pushed ABILIFY to the top sales position*2 among prescription drugs. On April 1, 2013, Otsuka began co-promotion of ABILIFY in Europe with H. Lundbeck A/S.
Marketing of Abilify Maintena, a once-monthly extended-release injection, began in the US in March 2013, as a new treatment option for schizophrenia, building on the success of ABILIFY. This was soon followed by the launch of marketing in Europe, and as of February 2015, the product is being sold in 18 European countries including the UK. In September 2014, marketing approval was obtained from the US Food and Drug Administration (FDA) for a new injectable formulation of Abilify Maintena in a ready-to-use prefilled syringe (the new pre-filled dual chamber syringe kit).
Otsuka acquired Avanir Pharmaceuticals, Inc. of the US in January 2015. The aim is to make a full-scale entry into the neurologic disease area, and also build upon the Otsuka’s presence in the psychiatric disease area and core business presence in the CNS field. In the US, Avanir sells NUEDEXTA, the world’s first and only approved treatment for the neurologic disease pseudobulbar affect (PBA). It is also engaged in the development of therapeutic agents in the neurologic disease field, such as agents for Alzheimer’s type dementia, and for Parkinson’s disease. Otsuka will continue to expand its business into the neurologic disease area, aiming to improve on the low treatment satisfaction in this area.

Oncology: Busulfex, the only drug approved by the US FDA for the conditioning regimen prior to hematopoietic progenitor cell transplantation, is now available in over 50 countries through Otsuka Pharmaceutical and its partners. It has become a standard treatment replacing radiotherapy within the bone marrow transplantation regimen. In December 2014, Otsuka signed an agreement with ARIAD Pharmaceuticals, Inc. to commercialize ARIAD’s treatment for resistant and intolerant chronic myeloid leukemia in Japan and nine other Asian countries*3 and regions, and to fund future clinical trials in those countries.

Cardiovascular: The vasopressin V2 receptor antagonist Samsca, which is now available in 20 countries and regions, has achieved good penetration in medical settings thanks to the new value and utility it provides as an oral aquaretic drug. In 2014, the world’s first approval of a treatment for autosomal dominant polycystic kidney disease (ADPKD), an intractable disease with no treatments until now, was obtained for Samsca in Japan. In 2015, approval recommendations of JINARC (global product name) were obtained in Canada as well as in Europe from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency.

Ophthalmology: Long- term prescriptions are now available for Mucosta ophthalmic suspension UD2%, a dry eye treatment that repairs the mucous membrane of the eye and promotes mucin production.

*1
©2015 IMS Health, All rights reserved. Estimated based on “World Review Preview 2014 (Year 2014 Sales Data).” Reprinted with permission.
*2
©2015 IMS Health, All rights reserved. Estimated based on “MIDAS Quantum 4Q/2013 Sales data.” Reprinted with permission.
*3
Japan, China (including Hong Kong), Indonesia, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam

As of March 2015

Nutraceutical Business*4

Helping Healthy People be Even
Healthier

Otsuka Pharmaceutical develops and delivers innovative products, based on cutting-edge science, to maintain and promote peoples' health around the world. Our nutraceutical business has defined and developed a totally new market in a unique way, as we communicate the value of our products to consumers in person.

The water and ion replenishment drink POCARI SWEAT is now being sold in 18 countries and regions, as of January 2015. In Japan, in April 2013 the company launched POCARI SWEAT ION WATER, which is suited to modern lifestyles with fewer calories, a light sweetness, and a refreshing aftertaste. In this way, POCARI SWEAT is still creating new markets as a rehydration beverage for everyday use, not just after actively perspiring.

In September 2014, a new item was added to the Calorie Mate lineup of balanced nutrition food products—Calorie Mate Plain. With the diversification of diets and eating styles, Calorie Mate is made for those seeking a nutritionally balanced food product containing five major nutrients that can be easily consumed by anyone, anywhere, at any time.

Otsuka Pharmaceutical has been focusing on developing new soy products and winning new customers based on the concept of “Soylution”*5—that soy can provide solutions to human health and environmental issues. In April 2012, the company launched the healthy soy snack SoyCarat. Along with the soy baked bar SOYJOY, which is now available in 11 countries and regions, and the sparkling soy water SOYSH, the company now has a lineup of three Soylution products. In April 2014, Japan saw the launch of SOYJOY Almond & Chocolate, followed by SoyCarat Chili Pepper in September of the same year.

With women’s health in mind, Otsuka Pharmaceutical released EQUELLE in April 2014. The food product contains equol and is easy to take every day.

In the Cosmedics*6 business for healthy skin, Otsuka Pharmaceutical launched a skin conditioner in the UL•OS brand of men’s skincare products in August 2014. UL•OS is expanding steadily as a familiar skincare brand for the whole body.

*4
Nutraceuticals: nutrition + pharmaceuticals
*5
Soylution: Soy + solution
*6
Cosmedics: cosmetics + medicine

As of March 2015