Market Overview

Otsuka to Host Web Briefing on Tolvaptan Phase 3 Trial Results in Polycystic Kidney Disease


Otsuka Pharmaceutical Co., Ltd. (OPCJ) and its affiliate Otsuka
Pharmaceutical Development & Commercialization, Inc. (OPDC) are pleased
to invite investors and media to a November 4 web briefing on in-depth
results from the REPRISE phase 3 trial for tolvaptan, a drug candidate
for the treatment of patients in the U.S. with autosomal dominant
polycystic kidney disease (ADPKD).


Webinar briefing for investors and media on November 4 at 7 PM,
US Central Daylight Time


  Welcome, introductions and overview (5 min.)
Robert McQuade, Ph.D., executive vice president/chief strategic
officer, OPDC

About ADPKD and Tolvaptan (15 min.)
Frank Czerwiec, M.D., Ph.D., vice president, Global Clinical
Development, OPDC

REPRISE phase 3 data (20 min.)
Ronald Perrone, M.D., scientific director, Clinical and
Translational Research Center and associate chief, Division of
Nephrology, Tufts Medical Center, Boston, MA, and a member of the
Phase 3 REPRISE trial Steering Committee

Q&A (20 min.)


To participate in the web briefing, kindly pre-register at:

Confirmation of registration and information on how to access the web
briefing on November 4 will be sent to registrants by email.

An archived version of the webcast will be accessible on the website of
Otsuka Pharmaceutical Company's parent company, Otsuka Holdings Co.,
Ltd., within 24 hours after the web briefing.

The REPRISE phase 3 trial data will also be presented earlier in the day
on November 4 in a late breaking oral abstract session at American
Society of Nephrology (ASN) Kidney Week 2017, in New Orleans (Abstract#
SA-OR128). Attendees of Kidney Week 2017 are invited to attend the
session, between 10:30 AM and 12:30 PM in Hall J.

The REPRISE trial was completed to supply confirmatory data to the
previous studyi to address the Complete Response Letter
issued by the U.S. FDA in 2013 for a New Drug Application for tolvaptan
in the treatment of adults with ADPKD.

About Tolvaptan
Tolvaptan is a selective vasopressin V2-receptor
antagonist. By selectively blocking vasopressin at the V2-receptor,
tolvaptan has been shown to decrease cyst-cell proliferation and fluid
secretion in subjects with ADPKD, ultimately reducing cyst development.ii
In a previous Phase 3 clinical trial, tolvaptan was associated with
reduced kidney growth and slowed decline of kidney function.i

About Otsuka
Otsuka Pharmaceutical Company is a global
healthcare company with the corporate philosophy: "Otsuka–people
creating new products for better health worldwide."

All Otsuka stories start by taking the road less travelled. Learn more
about Otsuka at
and connect with us in the US on LinkedIn and Twitter at @OtsukaUS.



  Torres VE, Harris PC et al. Tolvaptan in patients with autosomal
dominant polycystic kidney disease. NEJM. 2012;367 (25): 2407-2418


Reif, GA, Yamaguchi, T et al. Tolvaptan inhibits ERK-dependent cell
proliferation, Cl – secretion, and in vitro cyst growth of human
ADPKD cells stimulated by vasopressin. Am J Physiol Renal Physiol;
2011; 301:F1005-F1013

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