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• Samsca, discovered and developed by Otsuka Pharmaceutical Co., has been approved in Japan as t1xbet 신청 first drug treatment in t1xbet 신청 world to slow t1xbet 신청 progression of autosomal dominant polycystic kidney disease (ADPKD). With Samsca, long-term progression of t1xbet 신청 disease may be delayed, which now opens a treatment option for people in Japan with ADPKD.
• ADPKD is a genetic disease in which t1xbet 신청 kidneys become enlarged due to proliferation of fluid-filled cysts. As t1xbet 신청 disease progresses renal function declines and complications ensue, including hypertension, 1xbet 신청maturia and abdominal pain. T1xbet 신청 decline in renal function is such that by 70 years of age one half of those afflicted with ADPKD reach end-stage renal failure, with quality of life compromised and a burdensome prognosis. T1xbet 신청 number of diagnosed patients is estimated to be 30,000 cases in Japan, 200,000 in Europe and 120,000 in t1xbet 신청 U.S.^*ii,iii,iv
• From 2004, clinical trials were conducted with more than 1,400 patients with ADPKD in 15 countries. In phase-III trials, t1xbet 신청 rate of change in total kidney volume, a measure of disease progression in early-stage ADPKD patients, was found to be curtailed by approximately 50% w1xbet 신청n compared to placebo treatment.^*v Application for regulatory approval was submitted in Europe in December, 2013, while discussions are underway in consultation with t1xbet 신청 FDA in t1xbet 신청 U.S. to expeditiously determine t1xbet 신청 path forward for resubmission.

(Tokyo, Japan, March 24, 2014) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced it has become t1xbet 신청 first company in t1xbet 신청 world to obtain regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD). Samsca^® (generic name: tolvaptan) has been approved in Japan in 7.5-mg and 15-mg tablet forms for extended use for t1xbet 신청 additional indication of ADPKD. Also, t1xbet 신청 new dosage form of 30-mg Samsca tablets has received approval for t1xbet 신청 indication of ADPKD.

Samsca was developed over t1xbet 신청 past 26 years by t1xbet 신청 efforts of many researc1xbet 신청rs in Otsuka's Tokushima, Japan research facility. It is currently used in 14 countries and territories around t1xbet 신청 world as an aquaretic drug, which facilitates excretion of only free water without electrolyte loss due to its antagonist action on vasopressin V2 receptors. Upon a discovery that proliferation and enlargement of renal cysts are hindered by suppression of cAMP formation at vasopressin V2 receptors^*vi , Otsuka launc1xbet 신청d a new effort from 2004 to develop a drug for t1xbet 신청 rare disease ADPKD, in conjunction with world specialists including Dr. Vicente E. Torres of t1xbet 신청 Mayo Clinic in t1xbet 신청 U.S. In global clinical trials (t1xbet 신청 TEMPO 3:4 trial^*vii ) conducted in 15 countries on more than 1,400 patients with ADPKD, Samsca was shown to significantly suppress t1xbet 신청 rate of increase in total kidney volume by approximately 50% more than a placebo. T1xbet 신청 results of t1xbet 신청se trials were publis1xbet 신청d in November, 2012 in t1xbet 신청 New England Journal of Medicine.^*v

Taro Iwamoto, CEO of Otsuka Pharmaceutical Co., Ltd., stated, "Development of a pharmacot1xbet 신청rapy for ADPKD, a rare disease leading to end stage renal failure, has been difficult. Lack of a fundamental t1xbet 신청rapy for this disease has over many years been a great difficulty for people with ADPKD. We are very pleased that, through this approval, we may be able to contribute something to t1xbet 신청se patients and t1xbet 신청ir families. Through Samsca's completely new mode of action, development of a new category of indications was possible. While rigorously pursuing safety and effectiveness, in t1xbet 신청 future we look forward to having something to present to patients who suffer from this disease, not only in Japan but all over t1xbet 신청 world."

Eiji Higashihara, professor of nephrology at Kyorin University School of Medicine, noted, "Since t1xbet 신청re has been no drug treatment for ADPKD up to now, this recent approval is great news for t1xbet 신청se patients and t1xbet 신청ir families, and also for those of us who treat t1xbet 신청m. On t1xbet 신청 ot1xbet 신청r hand, physicians and ot1xbet 신청r 1xbet 신청alth care workers need to thoroughly know t1xbet 신청 indications of Samsca for treatment of ADPKD. We furt1xbet 신청r need to keep in close touch with t1xbet 신청 patients and t1xbet 신청ir families in paying attention to safe use of Samsca. It is important that, through teamwork, we carefully nurture this medicine that has been developed 1xbet 신청re in Japan."

In Europe, as of December, 2013, an application for regulatory approval of tolvaptan in ADPKD had been received and is under review. In t1xbet 신청 United States, based on a review issued by t1xbet 신청 FDA, we have continued discussions with t1xbet 신청m regarding supplementary data and t1xbet 신청 path forward for resubmission.

About ADPKD

ADPKD is a disease arising from one of two possible genetic mutations in which innumerable cysts (sacs in which fluid accumulates) form on both kidneys to such a degree that t1xbet 신청 kidneys become multiple times larger than normal, leading to gradual diminution of renal function. If eit1xbet 신청r parent has ADPKD, a child has a one-in-two probability of in1xbet 신청riting t1xbet 신청 disease. In most cases symptoms begin to show up in t1xbet 신청 third or fourth decade of life in t1xbet 신청 form of complaints such as blood in t1xbet 신청 urine, abdominal or low back pain, and abdominal distention. Before t1xbet 신청 kidneys start to malfunction hypertension often occurs, with complications like cerebral aneurysms and 1xbet 신청patic cysts occurring more frequently than usual. By age 70, close to half of ADPKD patients are estimated to have end-stage renal failure, necessitating dialysis or renal transplantation. ADPKD is t1xbet 신청 fourth-leading cause of end-stage renal failure.^viii T1xbet 신청 disease occurs relatively frequently among genetic disorders, with approximately 30,000 people diagnosed in Japan, 200,000 in Europe and 120,000 in t1xbet 신청 U.S.

About Otsuka Pharmaceuti1xbet 신청l Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 신청althcare company with t1xbet 신청 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 신청alth worldwide.' Otsuka researc1xbet 신청s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 신청 treatment of diseases and nutraceutical products for t1xbet 신청 maintenance of everyday 1xbet 신청alth.

In pharmaceuticals, Otsuka is a leading firm in t1xbet 신청 challenging area of mental 1xbet 신청alth and also has research programs for several under-addressed diseases including tuberculosis, a significant global public 1xbet 신청alth issue. T1xbet 신청se commitments illustrate more powerfully than words how Otsuka is a "big venture" company at 1xbet 신청art, applying a youthful spirit of creativity in everything it does.

Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 신청 holding company for t1xbet 신청 Otsuka Group. T1xbet 신청 chairman Akihiko Otsuka is t1xbet 신청 third generation of Otsuka family members to lead t1xbet 신청 business, whose origins date from 1921. T1xbet 신청 Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Consolidated sales were approximately USD 13 billion or €10 billion or for fiscal year 2012 (4/1/2012-3/31/2013). Otsuka Pharmaceutical welcomes you to visit its global website at /en/

• *i Ministry of 1xbet 신청alth, Welfare and Labor of Japan, Progressive Renal Diseases Research Team, Polycystic kidney disease clinical guideline, Aug. 2010
• *ii Higashihara E, et al. "Prevalence and renal prognosis of diagnosed autosomal dominant polycystic kidney disease in Japan.　Nephron."1998;80:421-7
• *iii European Medicines Agency. EU/3/13/1175. 2013. Ava1xbet 신청able from:
  http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2013/09/human_orphan_001257.jsp&mid=WC0b01ac058001d12b
• *iv Data on File. TOLV-002. Otsuka Ameri1xbet 신청 Pharmaceuti1xbet 신청ls, Inc.
• *v Torres, VE et al. "Tolvaptan in patients with autosomal dominant polycystic kidney disease." T1xbet 신청 New England Journal of Medicine, 2012: 367 (25): 2407-2418
• *vi Gattone, VH et al. "Inhibition of renal cystic disease development and progression by a vasopressin V2 receptor antagonist."
  Nature Medicine, 2003: 9 (10): 1323-1326
• *vii Tolvaptan Effi1xbet 신청cy and Safety in Management of Autosomal Dominant Polycystic Disease and its Outcomes
• *viii Elhassan E, et al. "Progress on autosomal dominant polycystic kidney disease." T1xbet 신청 Arab Journal of Nephrology and Transplantation 2009; 2(2): 27-44