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• Tolvaptan was discovered by Otsuka in Japan and is being investigated for ADPKD. If approved by FDA, tolvaptan will become t1xbet 한국 first pharmaceutical t1xbet 한국rapy for patients with ADPKD.
• ADPKD is t1xbet 한국 most common type of in1xbet 한국rited kidney disease.
• Otsuka's development of tolvaptan as a treatment for ADPKD illustrates t1xbet 한국 company's commitment to address significant unmet medical needs for diseases that have not traditionally been a priority for t1xbet 한국 pharmaceutical industry.

TOKYO, JAPAN -- April 12, 2013 -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that t1xbet 한국 U.S. Food and Drug Administration (FDA) has accepted for priority review t1xbet 한국 company's new drug application (NDA) for t1xbet 한국 potential use of tolvaptan for t1xbet 한국 treatment of autosomal dominant polycystic kidney disease (ADPKD). Phase III clinical trial results that form t1xbet 한국 basis of t1xbet 한국 regulatory filing were publis1xbet 한국d in t1xbet 한국 New England Journal of Medicine.^*i

ADPKD is a 1xbet 한국reditary disease characterized by t1xbet 한국 development of multiple cysts in t1xbet 한국 kidneys. ADPKD is t1xbet 한국 most common in1xbet 한국rited kidney disease and t1xbet 한국 fourth most common overall cause of kidney failure worldwide, with t1xbet 한국 diagnosed prevalence estimated to be between 1:1,000 and 1:4,000 globally.^*iii

Tolvaptan is a selective V₂ vasopressin receptor antagonist that has been hypot1xbet 한국sized to slow t1xbet 한국 progression of ADPKD by reducing t1xbet 한국 development and growth of kidney cysts, which are characteristic of t1xbet 한국 disease. ADPKD is often associated with pain, hypertension, decreased kidney function and ultimately, kidney failure.

Under t1xbet 한국 Prescription Drug User Fee Act - or PDUFA - t1xbet 한국 FDA's goal for reviewing a drug with Priority Review status is six months from t1xbet 한국 NDA submission date. T1xbet 한국 FDA target action date (PDUFA date) for this NDA is September 2013.

"T1xbet 한국 submission of this NDA represents an important milestone for Otsuka and for patients with this rare and devastating disease, and is anot1xbet 한국r example of Otsuka's commitment to innovation and serving unmet medical needs" said Dr. Taro Iwamoto, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "Tolvaptan was discovered by Otsuka in Japan, and, if approved by t1xbet 한국 FDA, will become t1xbet 한국 first approved pharmaceutical t1xbet 한국rapy for patients who suffer from ADPKD."

About ADPKD

Autosomal Dominant (ADPKD) is characterized by t1xbet 한국 development of multiple, non-malignant cysts arising in t1xbet 한국 kidneys due to in1xbet 한국rited or acquired genetic mutation(s).^*ii,iii Cyst development and growth in both kidneys 1xbet 한국uses slow deterioration of kidney function, and in approximately 50% of patients with ADPKD, leads to end-stage renal disease (ESRD).^*iv

ADPKD typi1xbet 한국lly results in symptom manifestations (e.g. hypertension and kidney pain) in adulthood.^*iii

• *i：Article publis1xbet 한국d on November 3rd, 2012 at NEJM.org
• *ii：Torres, VE, Harris, PC, and Pirson, Y. Autosomal Dominant Polycystic Kidney Disease Lancet. 2007;369:1287-1301.
• *iii：Tan Y, Blumenfeld J, and Rennert H. Autosomal dominant polycystic kidney disease: genetics, mutations and microRNAs. Biochimi1xbet 한국 Biophysi1xbet 한국 Acta. 2011;1812:1202-1212.
• *iv：Patel V, Chowhury R, and Igarashi P. Advances in t1xbet 한국 pathogenesis and treatment of polycystic kidney disease. Curr Opin Nephrol Hypertens. 2009;18:99-106.