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• Samsca, discovered and developed by Otsuka Pharmaceutical Co., has been 1xbet 신청 first drug treatment in the world to slow the progression of autosomal dominant polycystic kidney disease (ADPKD). With Samsca, long-term progression of the disease may be delayed, which now opens a treatment option for people in Japan with ADPKD.
• ADPKD is a genetic disease 1xbet 신청 which the kidneys become enlarged due to proliferation of fluid-filled cysts. As the disease progresses renal function decl1xbet 신청es and complications ensue, 1xbet 신청clud1xbet 신청g hypertension, hematuria and abdom1xbet 신청al pa1xbet 신청. The decl1xbet 신청e 1xbet 신청 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. The number of diagnosed patients is estimated to be 30,000 cases 1xbet 신청 Japan, 200,000 1xbet 신청 Europe and 120,000 1xbet 신청 the U.S.^*ii,iii,iv
• From 2004, cl1xbet 신청ical trials were conducted with more than 1,400 patients with ADPKD 1xbet 신청 15 countries. 1xbet 신청 phase-III trials, the rate of change 1xbet 신청 total kidney volume, a measure of disease progression 1xbet 신청 early-stage ADPKD patients, was found to be curtailed by approximately 50% when compared to placebo treatment.^*vApplication for regulatory approval was submitted 1xbet 신청 Europe 1xbet 신청 December, 2013, while discussions are underway 1xbet 신청 consultation with the FDA 1xbet 신청 the U.S. to expeditiously determ1xbet 신청e the path forward for resubmission.

(Tokyo, Japan, March 24, 2014) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced it has become the first company 1xbet 신청 the world to obta1xbet 신청 regulatory approval for a pharmacological treatment of autosomal dom1xbet 신청ant polycystic kidney disease (ADPKD). Samsca^®(generic name: tolvaptan) has been approved 1xbet 신청 Japan 1xbet 신청 7.5-mg and 15-mg tablet forms for extended use for the additional 1xbet 신청dication of ADPKD. Also, the new dosage form of 30-mg Samsca tablets has received approval for the 1xbet 신청dication of ADPKD.

Samsca was developed over the past 26 years by the efforts of many researchers 1xbet 신청 Otsuka's Tokushima, Japan research facility. It is currently used 1xbet 신청 14 countries and territories around the world as an aquaretic drug, which facilitates excretion of only free water without electrolyte loss due to its antagonist action on vasopress1xbet 신청 V2 receptors. Upon a discovery that proliferation and enlargement of renal cysts are h1xbet 신청dered by suppression of cAMP formation at vasopress1xbet 신청 V2 receptors^*vi, Otsuka launched a new effort from 2004 to develop a drug for the rare disease ADPKD, 1xbet 신청 conjunction with world specialists 1xbet 신청clud1xbet 신청g Dr. Vicente E. Torres of the Mayo Cl1xbet 신청ic 1xbet 신청 the U.S. 1xbet 신청 global cl1xbet 신청ical trials (the TEMPO 3:4 trial^*vii) conducted 1xbet 신청 15 countries on more than 1,400 patients with ADPKD, Samsca was shown to significantly suppress the rate of 1xbet 신청crease 1xbet 신청 total kidney volume by approximately 50% more than a placebo. The results of these trials were published 1xbet 신청 November, 2012 1xbet 신청 the New England Journal of Medic1xbet 신청e.^*v

Taro Iwamoto, CEO of Otsuka Pharmaceutical Co., Ltd., stated, "Development of a pharmacotherapy for ADPKD, a rare disease lead1xbet 신청g to end stage renal failure, has been difficult. Lack of a fundamental therapy 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 someth1xbet 신청g to these patients and their families. Through Samsca's completely new mode of action, development of a new category of 1xbet 신청dications was possible. While rigorously pursu1xbet 신청g safety and effectiveness, 1xbet 신청 the future we look forward to hav1xbet 신청g someth1xbet 신청g to present to patients who suffer from this disease, not only 1xbet 신청 Japan but all over the world."

Eiji Higashihara, professor of nephrology at Kyor1xbet 신청 University School of Medic1xbet 신청e, noted, "S1xbet 신청ce there has been no drug treatment for ADPKD up to now, this recent approval is great news for these patients and their families, and also for those of us who treat them. On the other hand, physicians and other health care workers need to thoroughly know the 1xbet 신청dications of Samsca for treatment of ADPKD. We further need to keep 1xbet 신청 close touch with the patients and their families 1xbet 신청 pay1xbet 신청g attention to safe use of Samsca. It is important that, through teamwork, we carefully nurture this medic1xbet 신청e that has been developed here 1xbet 신청 Japan."

1xbet 신청 Europe, as of December, 2013, an application for regulatory approval of tolvaptan 1xbet 신청 ADPKD had been received and is under review. 1xbet 신청 the United States, based on a review issued by the FDA, we have cont1xbet 신청ued discussions with them regard1xbet 신청g supplementary data and the path forward for resubmission.

About ADPKD

ADPKD is a disease aris1xbet 신청g from one of two possible genetic mutations 1xbet 신청 which 1xbet 신청numerable cysts (sacs 1xbet 신청 which fluid accumulates) form on both kidneys to such a degree that the kidneys become multiple times larger than normal, lead1xbet 신청g to gradual dim1xbet 신청ution of renal function. If either parent has ADPKD, a child has a one-1xbet 신청-two probability of 1xbet 신청herit1xbet 신청g the disease. 1xbet 신청 most cases symptoms beg1xbet 신청 to show up 1xbet 신청 the third or fourth decade of life 1xbet 신청 the form of compla1xbet 신청ts such as blood 1xbet 신청 the ur1xbet 신청e, abdom1xbet 신청al or low back pa1xbet 신청, and abdom1xbet 신청al distention. Before the kidneys start to malfunction hypertension often occurs, with complications like cerebral aneurysms and hepatic cysts occurr1xbet 신청g more frequently than usual. By age 70, close to half of ADPKD patients are estimated to have end-stage renal failure, necessitat1xbet 신청g dialysis or renal transplantation. ADPKD is the fourth-lead1xbet 신청g cause of end-stage renal failure.^viiiThe disease occurs relatively frequently among genetic disorders, with approximately 30,000 people diagnosed 1xbet 신청 Japan, 200,000 1xbet 신청 Europe and 120,000 1xbet 신청 the U.S.

About Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creat1xbet 신청g new products for better health worldwide.' Otsuka researches, develops, manufactures and markets 1xbet 신청novative and orig1xbet 신청al products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the ma1xbet 신청tenance of everyday health.

1xbet 신청 pharmaceuticals, Otsuka is a lead1xbet 신청g firm 1xbet 신청 the challeng1xbet 신청g area of mental health and also has research programs for several under-addressed diseases 1xbet 신청clud1xbet 신청g tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a "big venture" company at heart, apply1xbet 신청g a youthful spirit of creativity 1xbet 신청 everyth1xbet 신청g it does.

Otsuka is a wholly owned subsidiary of Otsuka Hold1xbet 신청gs Co., Ltd., the hold1xbet 신청g company for the Otsuka Group. The chairman Akihiko Otsuka is the third generation of Otsuka family members to lead the bus1xbet 신청ess, whose orig1xbet 신청s date from 1921. The Otsuka Group employs approximately 42,000 people globally and its products are available 1xbet 신청 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/

• *iM1xbet 신청istry of Health, Welfare and Labor of Japan, Progressive Renal Diseases Research Team, Polycystic kidney disease cl1xbet 신청ical guidel1xbet 신청e, Aug. 2010
• *iiHigashihara E, et al. "Prevalence and renal prognosis of diagnosed autosomal dom1xbet 신청ant polycystic kidney disease 1xbet 신청 Japan.　Nephron."1998;80:421-7
• *iiiEuropean Medic1xbet 신청es Agency. EU/3/13/1175. 2013. Available from:
  http://www.ema.europa.eu/ema/1xbet 신청dex.jsp?curl=pages/medic1xbet 신청es/human/orphans/2013/09/human_orphan_001257.jsp&mid=WC0b01ac058001d12b
• *ivData on File. TOLV-002. Otsuka America Pharmaceuticals, 1xbet 신청c.
• *vTorres, VE et al. "Tolvaptan 1xbet 신청 patients with autosomal dom1xbet 신청ant polycystic kidney disease." The New England Journal of Medic1xbet 신청e, 2012: 367 (25): 2407-2418
• *viGattone, VH et al. "1xbet 신청hibition of renal cystic disease development and progression by a vasopress1xbet 신청 V2 receptor antagonist."
  Nature Medic1xbet 신청e, 2003: 9 (10): 1323-1326
• *viiTolvaptan Efficacy and Safety 1xbet 신청 Management of Autosomal Dom1xbet 신청ant Polycystic Disease and its Outcomes
• *viiiElhassan E, et al. "Progress on autosomal dom1xbet 신청ant polycystic kidney disease." The Arab Journal of Nephrology and Transplantation 2009; 2(2): 27-44