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Otsuka – Key Facts

The Otsuka Group is a highly respected global healthcare company with a focus on
pharmaceutical products for the treatment of diseases, and consumer products for the
maintenance of everyday health. Ranked 20th globally and our corporate philosophy is:
‘Otsuka-people creating new products for better health worldwide’
It was Mr Busaburo Otsuka who founded the first Otsuka Factory in Naruto, Japan, in 1921.
Starting out as a small scale manufacturer of chemical raw materials, the company began
producing and selling intravenous solutions in 1946, marking its entry into the pharmaceutical
products market.
Otsuka Pharmaceutical Co., Ltd was established in 1964 and initiated the development of its
own new drugs in 1971. Otsuka’s sustained growth has enabled us to evolve from a small
pharmaceutical company, focusing on developing ethical drugs, into a global healthcare
corporation with a diverse product range.
The Otsuka Group comprises 145 companies in 23 countries and regions worldwide with over
39,000 employees with global sales of approximately €8.27 billion (FY to 31st March 2010).
The organisation in Europe was started in 1979 in Spain with the acquisition of Laboratorios
Miquel. Sales and marketing businesses in France, Germany, Italy, the Nordic region, Spain
and the UK are supported by the regional office of Otsuka Pharmaceutical Europe. Ltd.
(OPEL), based in London. The company has been operational in the Nordic and Baltic
regions since 2001, with a regional office in Stockholm.

Products
Otsuka currently markets the following products in the Nordic and Baltic regions:
Pletal® (cilostazol) - a medicinal product for the treatment of intermittent claudication. It is the first and only pharmaceutical approved for the treatment of disease symptoms, with the aim to prolong the stretch of pain-free walking distance. Adacolumn® apheresis treatment – a unique medical device treatment for inflammatory bowel disease (Crohn’s disease and ulcerative colitis). Patients suffering from inflammatory bowel disease present an increased level of white blood cells such as granulocytes and monocytes, which are known to increase during inflammation. These white blood cells in the blood are reduced through, for the body a mild technique, which in turn reduces their negative effects, and thus leads to an improvement in the patient’s condition. Samsca® (tolvaptan), the only vasopressin V2 receptor antagonist for the treatment of hyponatreamia (low sodium in the serum) in SIADH (Syndrome of Inappropriate Antidiuretic Hormone) in adults. SIADH may result from serious diseases such as cancer, infections and head injuries as well as side effect of some drugs. Samsca influences the very mechanism that is causing hyponatreamia. Birger Jarlsgatan 39, 111 45 Stockholm Sweden, Tel: +46-8-545-28660 Fax: +46-8-545-28669

Abilify® (aripiprazol) – for the treatment of patients with for the treatment of patients with schizophrenia and manic depressive episodes of bipolar disorders. It is based on the research conducted by the Swedish Novel Prize winner Arvid Carlsson on the dopamine system. The product has received over 10 distinctions, including that of the most innovative product in USA and Germany1,2. Abilify® is marketed in the Nordic region by our collaborative partner, Bristol Myers Squibb.
The company is currently in preparation for the launch of additional products.

Research

The company has 46 research centres worldwide and was ranked 4th in Jpaan in terms of R&D
investment with a spend of €1.1 billion (FY to 31st March 2010) . The Tokushima Research
Institute and the Frankfurt Research Institute in Germany was started in 1971 and 1982
respectively. The latter is focused on clinical research in Phases I, II, III and IV and provides
regulatory and pharmacovigilance servisec to the European business.
Fast facts on Otsuka
 Ranked 20th globally (Pharmaceutical Executive Europe - May 2010)  Ranked 4th in Japan in terms of R&D investment with a spend of €1,1billion (FY to  Ranked 4th in Japan in Pharmaceutical Sales  An international network of 145 companies  39,000 employees worldwide  Operating in 23 countries and regions across Asia-Pacific, the United States, Europe  137 Factories  Global sales of approximately $8.2 billion (FY to 31st March 2010). 1 Pharma Barometer, Most Innovative Neurological Product 2005, Innovation Award 2006 and 2007 (Germany) 2 Frost & Sullivan Product Innovation of the Year Award for Antipsychotic Medications 2004 (US) Birger Jarlsgatan 39, 111 45 Stockholm Sweden, Tel: +46-8-545-28660 Fax: +46-8-545-28669

Clinical studies

Pletal®
According to the international guidelines TASC II3, Pletal® (cilostazol) presents the best
medical evidence for the treatment of disease symptoms. Over 1.9 million patients have been
treated with Pletal worldwide, which is indicated to be a well tolerated and safe treatment
alternative.
Other clinical studies involving Pletal:
1. Hiatt WR et al. Long-term safety of cilostazol in patients with peripheral artery disease: The
CASTLE study. J Vasc Surg 2008;47: 330-336.
2. Beebe HG, Dawson DL, Cutler BS, et al. A new pharmacological treatment for intermittent
claudication. Arch Intern Med 1999;159:2041-2050.
3. Thompson PD et al.Meta Analysis of Results from Eight Randomized, Placebo-Controlled Trials on
the Effect of Cilostazol on Patients Intermittent Claudication. AM J Cardiol 2002; 90: 1314-1319.
Adacolumn® apheresis treatment
A retrospective study of over 100 patients whom underwent apheresis treatment with
Adacolumn at a total of 24 Scandinavian centres showed remission/response in 69% of the
patients4.
A selection of studies on Adacolumn apheresis treatment is as follows:
1. Maiden L, Takeuchi K, Baur R, Bjarnason I, O´Donohue J, Forgacs I, Chung-Faye G, Sanderson J,
Bjarnason Selective White Cell Apheresis Reduces Relapse Rates in Patients with IBD at Significant
Risk of Clinical Relapse: Inflammatory Bowel Disease 2008 Oct;14(10):1413-1418.
2. Sauerland S, Habermalz B, Neugebauer E A.M. A Meta-Analysis on the Clinical Effectiveness of
Selective Granulocyte and Monocyte Adsorptive (GMA) apheresis with the ADACOLUMN® device
in ulcerative colitis: Langenbecks Arch Surg (abstract) 2008; 393:759-815.
3. Hanai, H et al. Intensive Granulocyte and Monocyte Adsorption Versus Intravenous Prednisolone in
Patients with Severe Ulcerative Colitis: An Unblinded Randomised Multicentre Controlled Study:
Digestive and Liver Disease 2008;40:433-440.
4. Ruuska T, Lähdeaho M-L, Sutas Y, Ashorn M, Grönlund J. Leucocyte apheresis in the treatment of
paediatric ulcerative colitis: Scandinavian J. Gastro. 2007;42;1390-1391.
5. Kruis W, Dignass A, Steinhagen-Thiessen E, Morgenstern J, Mössner J, Schreiber S, Vecchi M,
Malesci A, Reinshagen M, Löfberg R. Open label trial of granulocyte apheresis suggests therapeutic
efficacy in chronically active steroid refractory ulcerative colitis: World Journal of Gastroeneterology
2005;11(44): 7001-7006.
3 TASC II. Eur J Vasc Endovasc Surg 2007; 33:suppl 1 4 Granulocyte, Monocyte/macrophage Apheresis for IBD in Clinical Practice. Clinical Results from the First 100 Patients Treated in Scandinavia. T Ljung, OO Thomsen, M Vatn, O Grip, P Karlén, A Kilander, R Gillberg, C Tysk, R Befrits, SU Nilsson, L N Karlsen, R Löfberg. Scandinavian Journal of Gastroenterology 2007; 42:221- Birger Jarlsgatan 39, 111 45 Stockholm Sweden, Tel: +46-8-545-28660 Fax: +46-8-545-28669

 
 
Samsca®
1. Verbalis J et al. Hyponatremia Treatment Guidelines 2007: Expert Panel
Recommendations. Am J Med 2007;120:S1 – S21.
2. Schrier RW et al. Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist, for
Hyponatremia. N Engl J Med 2006;355;2099-2112

Contact information – Otsuka in the Nordic region

Anders Nilsson, Managing Director, Otsuka Pharma Scandinavia AB.
Telephone: 08-545 286 60, mobile: 0702-52 02 74, e-mail: [email protected]
Charles Cline, Medical Director, Otsuka Pharma Scandinavia AB
Telephone: 08-545 286 60, e-mail: [email protected]
Mari Liljefors, Communications Director, Otsuka Pharma Scandinavia AB
Telephone: 08-545 286 62, mobile: 0702-25 60 37, e-mail: [email protected]
For additional information, please visit www.otsukapharma.info
Birger Jarlsgatan 39, 111 45 Stockholm Sweden, Tel: +46-8-545-28660 Fax: +46-8-545-28669

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