1xbet 신청 Pharmaceutical Co., Ltd.

• Samsca, discovered and developed by Otsuka Pharmaceutical Co., has been approved in Japan as 1xbet 신청 first drug treatment in 1xbet 신청 world to slow 1xbet 신청 progression of autosomal dominant polycystic kidney disease (ADPKD). With Samsca, long-term progression of 1xbet 신청 disease may be delayed, which now opens a treatment option for people in Japan with ADPKD.
• ADPKD is a genetic disease in which 1xbet 신청 kidneys become enlarged due to proliferation of fluid-filled cysts. As 1xbet 신청 disease progresses renal function declines and complications ensue, including hypertension, hematuria and abdominal pain. 1xbet 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. 1xbet 신청 number of diagnosed patients is estimated to be 30,000 cases in Japan, 200,000 in Europe and 120,000 in 1xbet 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, 1xbet 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% when compared to placebo treatment.^*vApplication for regulatory approval was submitted in Europe in December, 2013, while discussions are underway in consultation with 1xbet 신청 FDA in 1xbet 신청 U.S. to expeditiously determine 1xbet 신청 path forward for resubmission.

(Tokyo, Japan, March 24, 2014) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced it has become 1xbet 신청 first company in 1xbet 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 1xbet 신청 additional indication of ADPKD. Also, 1xbet 신청 new dosage form of 30-mg Samsca tablets has received approval for 1xbet 신청 indication of ADPKD.

Samsca was developed over 1xbet 신청 past 26 years by 1xbet 신청 efforts of many researchers in Otsuka's Tokushima, Japan research facility. It is currently used in 14 countries and territories around 1xbet 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 launched a new effort from 2004 to develop a drug for 1xbet 신청 rare disease ADPKD, in conjunction with world specialists including Dr. Vicente E. Torres of 1xbet 신청 Mayo Clinic in 1xbet 신청 U.S. In global clinical trials (1xbet 신청 TEMPO 3:4 trial^*vii) conducted in 15 countries on more than 1,400 patients with ADPKD, Samsca was shown to significantly suppress 1xbet 신청 rate of increase in total kidney volume by approximately 50% more than a placebo. 1xbet 신청 results of 1xbet 신청se trials were published in November, 2012 in 1xbet 신청 New England Journal of Medicine.^*v

Taro Iwamoto, CEO of Otsuka Pharmaceutical Co., Ltd., stated, "Development of a pharmaco1xbet 신청rapy for ADPKD, a rare disease leading to end stage renal failure, has been difficult. Lack of a fundamental 1xbet 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 1xbet 신청se patients and 1xbet 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 1xbet 신청 future we look forward to having something to present to patients who suffer from this disease, not only in Japan but all over 1xbet 신청 world."

Eiji Higashihara, professor of nephrology at Kyorin University School of Medicine, noted, "Since 1xbet 신청re has been no drug treatment for ADPKD up to now, this recent approval is great news for 1xbet 신청se patients and 1xbet 신청ir families, and also for those of us who treat 1xbet 신청m. On 1xbet 신청 o1xbet 신청r hand, physicians and o1xbet 신청r health care workers need to thoroughly know 1xbet 신청 indications of Samsca for treatment of ADPKD. We fur1xbet 신청r need to keep in close touch with 1xbet 신청 patients and 1xbet 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 here 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 1xbet 신청 United States, based on a review issued by 1xbet 신청 FDA, we have continued discussions with 1xbet 신청m regarding supplementary data and 1xbet 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 1xbet 신청 kidneys become multiple times larger than normal, leading to gradual diminution of renal function. If ei1xbet 신청r parent has ADPKD, a child has a one-in-two probability of inheriting 1xbet 신청 disease. In most cases symptoms begin to show up in 1xbet 신청 third or fourth decade of life in 1xbet 신청 form of complaints such as blood in 1xbet 신청 urine, abdominal or low back pain, and abdominal distention. Before 1xbet 신청 kidneys start to malfunction hypertension often occurs, with complications like cerebral aneurysms and hepatic 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 1xbet 신청 fourth-leading cause of end-stage renal failure.^viii1xbet 신청 disease occurs relatively frequently among genetic disorders, with approximately 30,000 people diagnosed in Japan, 200,000 in Europe and 120,000 in 1xbet 신청 U.S.

About 1xbet 신청 Pharmaceutical Co., Ltd.

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

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

Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., 1xbet 신청 holding company for 1xbet 신청 Otsuka Group. 1xbet 신청 chairman Akihiko Otsuka is 1xbet 신청 third generation of Otsuka family members to lead 1xbet 신청 business, whose origins date from 1921. 1xbet 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/

• *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 in patients with autosomal dominant polycystic kidney disease." 1xbet 신청 New England Journal of Medicine, 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 dominant polycystic kidney disease." 1xbet 신청 Arab Journal of Nephrology and Transplantation 2009; 2(2): 27-44